21st Century Cures Bill- Notes

Gibson`s bill

http://www.lymediseaseassociation.org/images/NewDirectory/Government/2015_789_Gibson.pdf

Smith`s bill - for comparison

http://www.lymediseaseassociation.org/images/NewDirectory/Government/2015_665_SmithBill.pdf

21st Century Cures Bill

http://docs.house.gov/meetings/IF/IF00/20150519/103516/BILLS-1146ih.pdf

May 20, 2015 My Notes... This bill is setting us all up to have and be controlled by the government and its buddies, IDSA, medical guidelines, amongst many other problems.

21st Century Cure Bill

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..................................................................... (Original Signature of Member)

H. R. ll

To accelerate the discovery, development, and delivery of 21st century cures,

and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

Mr. UPTON (for himself, Ms. DEGETTE, Mr. PITTS, Mr. PALLONE, and Mr. GENE GREEN of Texas) introduced the following bill; which was referred to the Committee on lllllllllllllll

114TH CONGRESS 1ST SESSION

A BILL

To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.

Be it enacted by the Senate and House of Representa- tives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the ‘‘21st Century Cures Act’’.

Pgs 9-10

‘‘(B) Research in which—

‘‘(i) a principal investigator has shown promise in biomedical research; and

‘‘(ii) funding is not tied to a specific project or specific objectives.

‘‘(C) Research to be carried out by an

early stage investigator (as defined in para- graph (7)).

‘‘(D) Research to be carried out by a small business concern (as defined in section 3 of the Small Business Act).

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‘‘(E) The Accelerating Advancement Pro-

gram under paragraph (5).

‘‘(F) Development and implementation of

the strategic plan under paragraph (6).

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Pgs. 10-11

‘(5) ACCELERATING ADVANCEMENT PRO- GRAM.—The Director of NIH shall establish a pro- gram, to be known as the Accelerating Advancement

Program, under which—

‘‘(A) the Director of NIH partners with

national research institutes and national centers to accomplish important biomedical research ob- jectives; and

‘‘(B) for every $1 made available by the Director of NIH to a national research institute or national center for a research project, the in- stitute or center makes $1 available for such

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project from funds that are not derived from

the NIH Innovation Fund.

Pgs. 11

‘‘(i) is designed to increase the effi- cient and effective focus of biomedical re- search in a manner that leverages the best scientific opportunities through a delibera- tive planning process;

Pgs. 11 & 12

‘‘(ii) identifies areas, to be known as strategic focus areas, in which the re- sources of the NIH Innovation Fund can contribute to the goals of expanding knowl- edge to address, and find more effective treatments for, unmet medical needs in the United States, including the areas of—

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‘‘(I) biomarkers;

‘‘(II) precision medicine;

‘‘(III) infectious diseases, includ-

ing pathogens listed as a qualifying

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pathogen under section 505E(f) of the Federal Food, Drug, and Cosmetic Act or listed or designated as a trop- ical disease under section 524 of such Act; and

‘‘(IV) antibiotics;

‘‘(iii) includes objectives for each such

strategic focus area; and

‘‘(iv) ensures that basic research re-

mains a priority.

‘‘(B) UPDATES AND REVIEWS.—The Direc- tor shall review and, as appropriate, update the research strategic plan under subparagraph (A) not less than every 18 months.

Pgs. 14

1. ‘‘(5) shall ensure that scientifically based stra-

2. 2 tegic planning is implemented in support of research

3. 3 priorities as determined by the agencies of the Na-

4. 4 tional Institutes of Health, including through devel-

5. 5 opment, use, and updating of the research strategic

6. 6 plan under subsection (m);’’; and

pgs. 15

‘‘(B) ENTITIES DESCRIBED.—The entities

described in this subparagraph are the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.

Pgs. 16

‘‘(A) STRATEGIC FOCUS AREAS.—The stra- tegic focus areas identified pursuant to para- graph (1)(A)(ii) shall—

‘‘(i) be identified in a manner that— ‘‘(I) considers the return on in- vestment to the United States public through the investments of the Na- tional Institutes of Health in bio-

medical research; and

‘‘(ii) include overarching and trans-

National Institutes of Health strategic focus areas, to be known as Mission Pri- ority Focus Areas, which best serve the goals of preventing or eliminating the bur- den of a disease or condition and scientif- ically merit enhanced and focused research over the next 5 years.

Pg. 18

SEC. 1022. INCREASING ACCOUNTABILITY AT THE NA- TIONAL INSTITUTES OF HEALTH.

(a) APPOINTMENT AND TERMS OF DIRECTORS OF NATIONAL RESEARCH INSTITUTES AND NATIONAL CEN- TERS.—Subsection (a) of section 405 of the Public Health Service Act (42 U.S.C. 284) is amended to read as follows:

‘‘(a) APPOINTMENT; TERMS.—

‘‘(1) APPOINTMENT.—The Director of the Na-

tional Cancer Institute shall be appointed by the President and the directors of the other national re- search institutes, as well as the directors of the na- tional centers, shall be appointed by the Director of NIH. The directors of the national research insti- tutes, as well as national centers, shall report di- rectly to the Director of NIH.

Pgs 19

‘‘(E) TRANSITIONAL PROVISION.—Each di- rector of a national research institute or na- tional center serving on the date of enactment of the 21st Century Cures Act is deemed to be appointed for a 5-year term under this sub- section starting on such date of enactment.’’.

1. ‘‘(3) Before an award is made by a national research

2. 13 institute or by a national center for a grant for a research

3. 14 program or project (commonly referred to as an ‘R-series

4. 15 grant’), other than an award constituting a noncompeting

5. 16 renewal of such grant, or a noncompeting administrative

6. 17 supplement to such grant, the director of such national

7. 18 research institute or national center—

pgs. 20

‘‘(A) shall review and approve the award; and ‘‘(B) shall take into consideration—

‘‘(i) the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section 402(m); and

Pgs 21

‘‘(ii) whether other agencies are funding

programs or projects to accomplish the same

goal.’’.

(d) IOM STUDY ON DUPLICATION IN FEDERAL BIO-

MEDICAL RESEARCH.—The Secretary of Health and Human Services shall enter into an arrangement with the Institute of Medicine of the National Academies (or, if the Institute declines, another appropriate entity) under which the Institute (or other appropriate entity) not later than 2 years after the date of enactment of this Act will—

(1) complete a study on the extent to which bio- medical research conducted or supported by Federal agencies is duplicative; and

(2) submit a report to the Congress on the re- sults of such study, including recommendations on how to prevent such duplication.

SEC. 1023. REDUCING ADMINISTRATIVE BURDENS OF RE- SEARCHERS.

(a) IMPLEMENTATION OF MEASURES TO REDUCE ADMINISTRATIVE BURDENS.—The Director of the Na- tional Institutes of Health shall implement measures to reduce the administrative burdens of researchers funded by the National Institutes of Health, taking into account the recommendations, evaluations, and plans researched by the following entities:

Pg 21

(d) IOM STUDY ON DUPLICATION IN FEDERAL BIO-

(1) complete a study on the extent to which bio- medical research conducted or supported by Federal agencies is duplicative; and

(2) submit a report to the Congress on the re- sults of such study, including recommendations on how to prevent such duplication.

Pgs. 33 & 34

(a) INPUT FROM EXPERTS.—Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a work- shop of experts on pediatrics and experts on geriatrics to provide input on—

(1) appropriate age groupings to be included in research studies involving human subjects; and

(2) acceptable scientific justifications for ex- cluding participants from a range of age groups from human subjects research studies.

(b) GUIDELINES.—Not later than 180 days after the

conclusion of the workshop under subsection (a), the Di- rector of the National Institutes of Health shall publish guidelines—

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1. 1 (1) addressing the consideration of age as an

2. 2 inclusion variable in research involving human sub-

3. 3 jects; and

4. 4 (2) identifying criteria for justifications for any

5. 5 age-related exclusions in such research.

Pg 35- NOT GOOD

‘‘(m) SHARING OF DATA GENERATED THROUGH NIH-FUNDED RESEARCH.—

‘‘(1) AUTHORITY.—Subject to paragraph (2), the Director of NIH may require recipients of the award of an NIH grant or other financial support, provided that the research is fully funded through such grant or other support, to share scientific data generated from research conducted through such support for research purposes.

‘‘(2) LIMITATION.—The Director of NIH shall not require the sharing of data that is inconsistent with applicable law and policy protecting—

‘‘(A) privacy and confidentiality;

‘‘(B) proprietary interests;

‘‘(C) business confidential information; ‘‘(D) intellectual property rights; and ‘‘(E) other relevant rights.’’.

Bad for doctors- It doesn’t exclude doctors info

Pgs 37 & 38

1. 15 (2) CONFORMING AMENDMENT.—Clause (iv) of

2. 16 section 402(j)(2)(B) of the Public Health Service

3. 17 Act (42 U.S.C. 282(j)(2)(B)) is hereby stricken.

4. 18 (b) CONSULTATION.—Not later than 90 days after

5. 19 the date of enactment of this Act, the Secretary of Health

6. 20 and Human Services shall consult with stakeholders (in-

7. 21 cluding patients, researchers, physicians, industry rep-

8. 22 resentatives, health information technology providers, the

9. 23 Food and Drug Administration, and standard setting or-

10. 24 ganizations such as CDISC that have experience working

11. 25 with Federal agencies to standardize health data submis-

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1. 1 sions) to receive advice on enhancements to the clinical

2. 2 trial registry data bank under section 402(j) of the Public

3. 3 Health Service Act (42 U.S.C. 282(j)) (including enhance-

4. 4 ments to usability, functionality, and search capability)

5. 5 that are necessary to implement paragraph (7) of section

6. 6 402(j) of such Act, as added by subsection (a).

pgs. 38-41

1. ESTABLISHMENT.—The Secretary, acting

2. 16 through the Commissioner of Food and Drugs and the Di-

3. 17 rector of the National Institutes of Health, shall enter into

4. 18 a cooperative agreement, contract, or grant for a period

5. 19 of 7 years, to be known as the Clinical Trial Data System

6. 20 Agreement, with one or more eligible entities to implement

7. 21 a pilot program with respect to all clinical trial data ob-

8. 22 tained from qualified clinical trials for purposes of reg-

9. 23 istered users conducting further research on such data.

10. 24 (b) APPLICATION.—Eligible entities seeking to enter

11. 25 into a cooperative agreement, contract, or grant with the

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1. 1 Secretary under this section shall submit to the Secretary

2. 2 an application in such time and manner, and containing

3. 3 such information, as the Secretary may require in accord-

4. 4 ance with this section. The Secretary shall not enter into

5. 5 a cooperative agreement, contract, or grant with an eligi-

6. 6 ble entity unless such entity submits an application includ-

7. 7 ing the following:

8. 8 (1) A certification that the eligible entity is not

9. 9 currently and does not plan to be involved in spon-

10. 10 soring, operating, or participating in a clinical trial

11. 11 nor collaborating with another entity for the pur-

12. 12 poses of sponsoring, operating, or participating in a

13. 13 clinical trial.

14. 14 (2) Information demonstrating that the eligible

15. 15 entity can compile clinical trial data in standardized

16. 16 formats using terminologies and standards that have

17. 17 been developed by recognized standards developing

18. 18 organizations with input from diverse stakeholder

19. 19 groups, and information demonstrating that the eli-

20. 20 gible entity can de-identify clinical trial data con-

21. 21 sistent with the requirements of section 164.514 of

22. 22 title 45, Code of Federal Regulations (or successor

23. 23 regulations).

24. 24 (3) A description of the system the eligible enti-

25. 25 ty will use to store and maintain such data, and in-

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1. 1 formation demonstrating that this system will com-

2. 2 ply with applicable standards and requirements for

3. 3 ensuring the security of the clinical trial data.

4. 4 (4) A certification that the eligible entity will

5. 5 allow only registered users to access and use de-

6. 6 identified clinical trial data, gathered from qualified

7. 7 clinical trials, and that the eligible entity will allow

8. 8 each registered user to access and use such data

9. 9 only after such registered user agrees in writing to

10. 10 the terms described in (e)(4)(B), and such other

11. 11 carefully controlled contractual terms as may be de-

12. 12 fined by the Secretary.

13. 13 (5) Evidence demonstrating the ability of the

14. 14 eligible entity to ensure that registered users dis-

15. 15 seminate the results of the research conducted in ac-

16. 16 cordance with this section to interested parties to

17. 17 serve as a guide to future medical product develop-

18. 18 ment or scientific research.

19. 19 (6) The plan of the eligible entity for securing

20. 20 funding for the activities it would conduct under the

21. 21 clinical trial data system agreement from govern-

22. 22 mental sources and private foundations, entities, and

23. 23 individuals.

24. 24 (7) Evidence demonstrating a proven track

25. 25 record of—

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(A) being a neutral third party in working

with medical product manufacturers, academic institutions, and the Food and Drug Adminis- tration; and

(B) having the ability to protect confiden- tial data.

(8) An agreement that the eligible entity will work with the Comptroller General of the United States for purposes of the study and report in sub- section (d).

Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, upon the expiration of the 7-year period referred to in subsection (a), may extend (including permanently), expand, or terminate the pilot program established under such subsection, in whole, or in part.

Neurological Diseases- not good

53-56

‘‘SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART

OF HEALTH CARE OPERATIONS.

‘‘(a) IN GENERAL.—Subject to subsection (b), the Secretary shall revise or clarify the rule to allow the use and disclosure of protected health information by a cov-

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‘‘(A) another covered entity for health care operations (as defined in such section 164.501 of part 164);

‘‘(B) a business associate that has entered into a contract under section 164.504(e) of part 164 with a disclosing covered entity to perform health care operations; or

‘‘(C) a business associate that has entered into a contract under section 164.504(e) of part 164 for the purpose of data aggregation (as de- fined in such section 164.501 of part 164); and

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1. 1 ered entity for research purposes, including studies whose

2. 2 purpose is to obtain generalizable knowledge, to be treated

3. 3 as the use and disclosure of such information for health

4. 4 care operations described in subparagraph (1) of the defi-

5. 5 nition of health care operations in section 164.501 of part

6. 6 164.

7. 7 ‘‘(b) MODIFICATIONS TO RULES FOR DISCLOSURES

8. 8 FOR HEALTH CARE OPERATIONS.—In applying section

9. 9 164.506 of part 164 to the disclosure of protected health

10. 10 information described in subsection (a)—

11. 11 ‘‘(1) the Secretary shall revise or clarify the

12. 12 Rule so that the disclosure may be made by the cov-

13. 13 ered entity to only—

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‘‘(2) the Secretary shall further revise or clarify

the Rule so that the limitation specified by section 164.506(c)(4) of part 164 does not apply to disclo- sures that are described by subsection (a).

‘‘(c) RULE OF CONSTRUCTION.—This section shall

not be construed as prohibiting or restricting a use or dis- closure of protected health information for research pur- poses that is otherwise permitted under part 164.

‘‘SEC. 13443. TREATING DISCLOSURES OF PROTECTED

HEALTH INFORMATION FOR RESEARCH SIMI- LARLY TO DISCLOSURES OF SUCH INFORMA- TION FOR PUBLIC HEALTH PURPOSES.

‘‘(a) REMUNERATION.—The Secretary shall revise or clarify the Rule so that disclosures of protected health in- formation for research purposes are not subject to the lim- itation on remuneration described in section 164.502(a)(5)(ii)(B)(2)(ii) of part 164.

‘‘(b) PERMITTED USES AND DISCLOSURES.—The Secretary shall revise or clarify the Rule so that research activities, including comparative research activities, re- lated to the quality, safety, or effectiveness of a product or activity that is regulated by the Food and Drug Admin- istration are included as public health activities for pur- poses of which a covered entity may disclose protected

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health information to a person described in section

164.512(b)(1)(iii) of part 164.

Pg 57-58

‘‘SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED HEALTH INFORMATION BY RESEARCHERS.

‘‘The Secretary shall revise or clarify the Rule so that subparagraph (B) of section 164.512(i)(1)(ii) of part 164 (prohibiting the removal of protected health information by a researcher) shall not prohibit remote access to health information by a researcher so long as—

‘‘(1) appropriate security and privacy safe- guards are maintained by the covered entity and the researcher; and

‘‘(2) the protected health information is not copied or otherwise retained by the researcher.

‘‘SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE AND DISCLOSURE OF PROTECTED HEALTH

INFORMATION FOR RESEARCH PURPOSES.

‘‘(a) IN GENERAL.—The Secretary shall revise or clarify the Rule to specify that an authorization for the use or disclosure of protected health information, with re- spect to an individual, for future research purposes shall be deemed to contain a sufficient description of the pur- pose of the use or disclosure if the authorization—

‘‘(1) sufficiently describes the purposes such that it would be reasonable for the individual to ex-

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pect that the protected health information could be

used or disclosed for such future research; ‘‘(2) either—

‘‘(A) states that the authorization will ex- pire on a particular date or on the occurrence of a particular event; or

‘‘(B) states that the authorization will re- main valid unless and until it is revoked by the individual; and

‘‘(3) provides instruction to the individual on

how to revoke such authorization at any time.

‘‘(b) REVOCATION OF AUTHORIZATION.—The Sec- retary shall revise or clarify the Rule to specify that, if an individual revokes an authorization for future research purposes such as is described by subsection (a), the cov- ered entity may not make any further uses or disclosures based on that authorization, except, as provided in para- graph (b)(5) of section 164.508 of part 164, to the extent that the covered entity has taken action in reliance on the authorization.’’.

(b) REVISION OF REGULATIONS.—Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall revise and clarify the provisions of title 45, Code of Federal Regula-

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1. 1 tions, for consistency with part 4 of subtitle D of the

2. 2 HITECH Act, as added by subsection (a).

Pgs 58-60- Ugggggg!

1. ‘‘PART E—COUNCIL FOR 21ST CENTURY CURES

2. 10 ‘‘SEC. 281. ESTABLISHMENT.

3. 11 ‘‘A nonprofit corporation to be known as the Council

4. 12 for 21st Century Cures (referred to in this part as the

5. 13 ‘Council’) shall be established in accordance with this sec-

6. 14 tion. The Council shall be a public-private partnership

7. 15 headed by an Executive Director (referred to in this part

8. 16 as the ‘Executive Director’), appointed by the members

9. 17 of the Board of Directors. The Council shall not be an

10. 18 agency or instrumentality of the United States Govern-

11. 19 ment.

12. 20 ‘‘SEC. 281A. PURPOSE.

13. 21 ‘‘The purpose of the Council is to accelerate the dis-

14. 22 covery, development, and delivery in the United States of

15. 23 innovative cures, treatments, and preventive measures for

16. 24 patients.

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‘‘SEC. 281B. DUTIES.

‘‘For the purpose described in section 281A, the Council shall—

‘‘(1) foster collaboration and coordination among the entities that comprise the Council, includ- ing academia, government agencies, industry, health care payors and providers, patient advocates, and others engaged in the cycle of discovery, develop- ment, and delivery of life-saving and health-enhanc- ing innovative interventions;

‘‘(2) undertake communication and dissemina- tion activities;

‘‘(3) publish information on the activities fund- ed under section 281D;

‘‘(4) establish a strategic agenda for accel- erating the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients;

‘‘(5) identify gaps and opportunities within and across the discovery, development, and delivery cycle; ‘‘

(6) develop and propose recommendations

based on the gaps and opportunities so identified; ‘‘

(7) facilitate the interoperability of the compo- nents of the discovery, development, and delivery

cycle;

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‘‘(8) propose recommendations that will facili-

tate precompetitive collaboration;

‘‘(9) identify opportunities to work with, but

not duplicate the efforts of, nonprofit organizations and other public-private partnerships; and

‘‘(10) identify opportunities for collaboration with organizations operating outside of the United States, such as the Innovative Medicines Initiative of the European Union

pgs. 61 - 63

BOARD OF DIRECTORS.— ‘‘(1) ESTABLISHMENT.—

‘‘(A) IN GENERAL.—The Council shall have a Board of Directors (in this part referred to as the ‘Board of Directors’), which shall be composed of the ex officio members under sub- paragraph (B) and the appointed members under subparagraph (C). All members of the Board shall be voting members.

‘‘(B) EX OFFICIO MEMBERS.—The ex offi- cio members of the Board shall be the following individuals or their designees:

‘‘(i) The Director of the National In- stitutes of Health.

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‘‘(ii) The Commissioner of Food and

Drugs.

‘‘(iii) The Administrator of the Cen-

ters for Medicare & Medicaid Services. ‘‘(iv) The heads of five other Federal agencies deemed by the Secretary to be en- gaged in biomedical research and develop-

ment.

‘‘(C) APPOINTED MEMBERS.—The ap- pointed members of the Board shall consist of 17 individuals, of whom—

‘‘(i) 8 shall be by the Comptroller General of the United States from a list of nominations submitted by leading trade as- sociations—

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‘‘(I) 4 of whom shall be rep- resentatives of the biopharmaceutical industry;

‘‘(II) 2 of whom shall be rep- resentatives of the medical device in- dustry; and

‘‘(III) 2 of whom shall be rep- resentatives of the information and digital technology industry; and

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‘‘(ii) 9 shall be appointed by the

Comptroller General of the United States, after soliciting nominations—

‘‘(I) 2 of whom shall be rep- resentatives of academic researchers;

‘‘(II) 3 of whom shall be rep- resentative of patients;

‘‘(III) 2 of whom shall be rep- resentatives of health care providers; and

‘‘(IV) 2 of whom shall be rep- resentatives of health care plans and insurers.

‘‘(D) CHAIR.—The Chair of the Board shall be selected by the members of the Board by majority vote from among the members of the Board.

‘‘(2) TERMS AND VACANCIES.—

‘‘(A) IN GENERAL.—The term of office of each member of the Board appointed under paragraph (1)(C) shall be 5 years.

‘‘(B) VACANCY.—Any vacancy in the mem- bership of the Board—

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‘‘(A) are published in the Federal Register and available for public comment;

‘‘(B) establish policies for the selection and, as applicable, appointment of—

‘‘(i) the officers, employees, agents, and contractors of the Council; and

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1. 1 ‘‘(i) shall not affect the power of the

2. 2 remaining members to execute the duties

3. 3 of the Board; and

4. 4 ‘‘(ii) shall be filled by appointment by

5. 5 the appointed members described in para-

6. 6 graph (1)(C) by majority vote.

Sidenote-

Gene L. Dodaro became the eighth Comptroller General of the United States and head of the U.S. Government Accountability Office (GAO) on December 22, 2010, when he was confirmed by the United States Senate. He was nominated by President Obama in September of 2010 from a list of candidates selected by a bipartisan, bicameral congressional commission. He had been serving as Acting Comptroller General since March of 2008. http://www.gao.gov/cghome/gdbiog.html

pgs 81

‘‘(2) RELATION TO TRADE SECRETS ACT.—In- formation made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18, United States Code.

Pg 82

1. 16 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

2. 17 are authorized to be appropriated to carry out this section,

3. 18 $10,000,000 for each of fiscal years 2016 through 2020.

Pg. 83

1. 19 ‘‘(f) DEFINITIONS.—In this section:

2. 20 ‘‘(1) BIOMARKER.—(A) The term ‘biomarker’

3. 21 means a characteristic (such as a physiologic,

4. 22 pathologic, or anatomic characteristic or measure-

5. 23 ment) that is objectively measured and evaluated as

6. 24 an indicator of normal biologic processes, pathologic

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1. 1 processes, or biological responses to a therapeutic

2. 2 intervention; and

3. 3 ‘‘(B) such term includes a surrogate endpoint.

4. 4 ‘‘(2) BIOMEDICAL RESEARCH CONSORTIA.—The

5. 5 term ‘biomedical research consortia’ means collabo-

6. 6 rative groups that may take the form of public-pri-

7. 7 vate partnerships and may include government agen-

8. 8 cies, institutions of higher education (as defined in

9. 9 section 101(a) of the Higher Education Act of 1965

10. 10 (20 U.S.C. 1001)), patient advocacy groups, indus-

11. 11 try representatives, clinical and scientific experts,

12. 12 and other relevant entities and individuals.

13. 13 ‘‘(3) CLINICAL OUTCOME ASSESSMENT.—(A)

14. 14 The term ‘clinical outcome assessment’ means a

15. 15 measurement of a patient’s symptoms, overall men-

16. 16 tal state, or the effects of a disease or condition on

17. 17 how the patient functions; and

18. 18 ‘‘(B) such term includes a patient-reported out-

19. 19 come.

20. 20 ‘‘(4) CONTEXT OF USE.—The term ‘context of

21. 21 use’ means, with respect to a drug development tool,

22. 22 a statement that describes the circumstances under

23. 23 which the drug development tool is to be used in

24. 24 drug development and regulatory review.

Pg 87

(A) update and finalize the draft guidance

addressing the use of adaptive trial design for drugs and biological products; and

(B) issue draft guidance on the use of Bayesian methods in the development and regu- latory review and approval or licensure of drugs and biological products.

Pg. 98

1. (3) PUBLIC MEETING.—Prior to updating or

2. 3 developing the guidances required by paragraph (1),

3. 4 the Secretary shall consult with stakeholders, includ-

4. 5 ing representatives of regulated industry, academia,

5. 6 patient advocacy organizations, and disease research

6. 7 foundations, through a public meeting to be held not

7. later than 1 year after the date of enactment of this

8. 9 Act.

????????????????????????????

Pg 99

‘‘SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERI- ENCE.

‘‘(a) IN GENERAL.—The Secretary shall establish a program to evaluate the potential use of evidence from clinical experience—

‘‘(1) to help support the approval of a new indi- cation for a drug approved under section 505(b); and

‘‘(2) to help support or satisfy postapproval study requirements.

‘‘(b) EVIDENCE FROM CLINICAL EXPERIENCE DE-

FINED.—In this section, the term ‘evidence from clinical experience’ means data regarding the usage, or the poten- tial benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observa- tional studies, registries, and therapeutic use.

Pgs 100-101

‘(3) CONSULTATION.—

‘‘(A) IN GENERAL.—In developing the pro- gram framework under this subsection, the Sec- retary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organiza- tions, disease research foundations, and other interested parties.

‘‘(B) PROCESS.—The consultation under subparagraph (A) may be carried out through approaches such as—

‘‘(i) a public-private partnership with the entities described in such subparagraph in which the Secretary may participate; or

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101

‘‘(ii) a contract, grant, or other ar-

rangement, as determined appropriate by the Secretary with such a partnership or an independent research organization.

101

‘(2) not later than 36 months after the date of

enactment of this section, issue draft guidance for industry as described in paragraph (1); and

‘‘(3) not later than 48 months after the date of enactment of this section, after providing an oppor- tunity for public comment on the draft guidance, issue final guidance.

102

‘‘(2) This section shall not be construed to alter—

‘‘(A) the standards of evidence under— ‘‘(i) subsection (c) or (d) of section 505, including the substantial evidence

standard in such subsection (d); or

‘‘(ii) section 351(a) of the Public

Health Service Act; or

‘‘(B) the Secretary’s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.

Pgs. 104-105

‘‘(A) consult with regulated industry, aca- demia, medical professional organizations, rep- resentatives of patient advocacy organizations, disease research foundations, and other inter- ested parties through a public process; and

‘‘(B) develop a framework to promote ap- propriate transparency and dialogue about re- search conducted under these pilot demonstra- tions, including by—

‘(i) providing adequate notice to a sponsor of a drug approved under section 505 or section 351 of the Public Health Service Act of the Secretary’s intent to conduct analyses of such sponsor’s drug or drugs under these pilot demonstrations;

‘‘(ii) providing adequate notice of the findings related to analyses described in clause (i) and an opportunity for the spon- sor of such drug or drugs to comment on such findings; and

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1 and infrastructure the Secretary determines ap-

2. 2 propriate and necessary.

3. 3 ‘‘(2) CONSULTATION.—In developing the pilot

4. 4 demonstrations under this subsection, the Secretary

5. 5 shall—

6 7 8 9

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‘‘(A) deem such pilot demonstrations pub- lic health activities, permitting the use and dis- closure of protected health information as de- scribed in section 164.512(b)(1)(iii) of title 45, Code of Federal Regulations (or any successor regulation) and exempted as a public health ac- tivity as described in section 46.101(b)(5) of title 46, Code of Federal Regulations (or any successor regulation); and

‘‘(B) deem safety surveillance performed at the request of the Food and Drug Administra- tion or under such jurisdiction by a sponsor with responsibility for a drug approved under this section or section 351 of the Public Health Services Act using the Sentinel System surveil- lance infrastructure authorized under section 505(k), including use of analytic tools and

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1. 1 ‘‘(iii) ensuring the protection from

2. 2 public disclosure of any information that is

3. 3 a trade secret or confidential information

4. 4 subject to section 552(b)(4) of title 5,

5. 5 United States Code, or section 1905 of

6. 6 title 18, United States Code.

1. PUBLIC HEALTH EXEMPTION.—The Sec-

2. 8 retary may—

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1. 1 ‘‘(iii) ensuring the protection from

2. 2 public disclosure of any information that is

3. 3 a trade secret or confidential information

4. 4 subject to section 552(b)(4) of title 5,

5. 5 United States Code, or section 1905 of

6. 6 title 18, United States Code.

7. 7 ‘‘(3) PUBLIC HEALTH EXEMPTION.—The Sec-

8. 8 retary may—

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106

1. 1 querying capabilities developed to implement

2. 2 the active postmarket surveillance system de-

3. 3 scribed in this section, public health activities

4. 4 as described in section 164.512(b)(1)(iii) of title

5. 5 45, Code of Federal Regulations (or any suc-

6. 6 cessor regulation) and exempted as a public

7. 7 health activity as described in section

8. 8 46.101(b)(5) of title 46, Code of Federal Regu-

9. 9 lations (or any successor regulation).

1. ‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

2. 11 are authorized to be appropriated to carry out this section

3. 12 $3,000,000 for each of fiscal years 2016 through 2020.’’.

4. 13 SEC. 2063. STREAMLINED DATA REVIEW PROGRAM.

Pgs 107

1. ‘‘(3) there is an existing database acceptable to

2. 19 the Secretary regarding the safety of the drug devel-

3. 20 oped for one or more indications of the drug ap-

4. 21 proved under such section 505(c) or licensed under

5. 22 such section 351(a);

pgs 110

1. SEC. 2081. SENSE OF CONGRESS. (NONE)

2. 12 It is the sense of Congress that the Food and Drug

3. 13 Administration should continue to expedite the approval

4. 14 of drugs designated as breakthrough therapies pursuant

5. 15 to section 506(a) of the Federal Food, Drug, and Cos-

6. 16 metic Act (21 U.S.C. 356(a)) by approving drugs so des-

7. 17 ignated as early as possible in the clinical development

8. 18 process, regardless of the phase of development, provided

9. 19 that the Secretary of Health and Human Services deter-

10. 20 mines that an application for such a drug meets the stand-

11. 21 ards of evidence of safety and effectiveness under section

12. 22 505 of such Act (21 U.S.C. 355), including the substantial

13. 23 evidence standard under subsection (d) of such section or

14. 24 under section 351(a) of the Public Health Service Act (42

15. 25 U.S.C. 262(a)).

Pg 112

‘‘(d) REVISED POLICY.—A manufacturer or dis- tributor that has made a policy publicly available as re- quired by this section may revise the policy at any time.

Pgs. 113-115

SEC. 2101. FACILITATING DISSEMINATION OF HEALTH CARE ECONOMIC INFORMATION. YULK YULK YULK YULK!!!!!

Section 502(a) of the Federal Food, Drug, and Cos- metic Act (21 U.S.C. 352(a)) is amended—

(1) by striking ‘‘(a) If its’’ and inserting ‘‘(a)(1) If its’’;

(2) by striking ‘‘a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations’’ and inserting ‘‘a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic

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114

1. 1 analysis, carrying out its responsibilities for the se-

2. 2 lection of drugs for coverage or reimbursement’’;

3. 3 (3) by striking ‘‘directly relates’’ and inserting

4. 4 ‘‘relates’’;

5. 5 (4) by striking ‘‘and is based on competent and

6. 6 reliable scientific evidence. The requirements set

7. 7 forth in section 505(a) or in section 351(a) of the

8. 8 Public Health Service Act shall not apply to health

9. 9 care economic information provided to such a com-

10. 10 mittee or entity in accordance with this paragraph’’

11. 11 and inserting ‘‘, is based on competent and reliable

12. 12 scientific evidence, and includes, where applicable, a

13. 13 conspicuous and prominent statement describing any

14. 14 material differences between the health care eco-

15. 15 nomic information and the labeling approved for the

16. 16 drug under section 505 or under section 351 of the

17. 17 Public Health Service Act. The requirements set

18. 18 forth in section 505(a) or in subsections (a) and (k)

19. 19 of section 351 of the Public Health Service Act shall

20. 20 not apply to health care economic information pro-

21. 21 vided to such a payor, committee, or entity in ac-

22. 22 cordance with this paragraph’’; and

23. 23 (5) by striking ‘‘In this paragraph, the term’’

24. 24 and all that follows and inserting the following:

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1. 1 ‘‘(2)(A) For purposes of this paragraph, the term

2. 2 ‘health care economic information’ means any analysis (in-

3. 3 cluding the clinical data, inputs, clinical or other assump-

4. 4 tions, methods, results, and other components underlying

5. 5 or comprising the analysis) that identifies, measures, or

6. 6 describes the economic consequences, which may be based

7. 7 on the separate or aggregated clinical consequences of the

8. 8 represented health outcomes, of the use of a drug. Such

9. 9 analyses may be comparative to the use of another drug,

10. 10 to another health care intervention, or to no intervention.

Pgs. 115

1. SEC. 2102. FACILITATING RESPONSIBLE COMMUNICATION

2. 16 OF SCIENTIFIC AND MEDICAL DEVELOP-

3. 17 MENTS.

4. 18 (a) GUIDANCE.—Not later than 18 months after the

5. 19 date of enactment of this Act, the Secretary of Health and

6. 20 Human Services shall issue draft guidance on facilitating

7. 21 the responsible dissemination of truthful and non-mis-

8. 22 leading scientific and medical information not included in

9. 23 the approved labeling of drugs and devices.

Pg. 116 Antibiotic Bull

(b) APPROVAL OF CERTAIN ANTIBACTERIAL AND ANTIFUNGAL DRUGS.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 2001, is further amended by adding at the end the following new subsection:

‘‘(z) APPROVAL OF CERTAIN ANTIBACTERIAL AND ANTIFUNGAL DRUGS FOR USE IN A LIMITED POPU- LATION OF PATIENTS.—

‘‘(1) PROCESS.—At the request of the sponsor of an antibacterial or antifungal drug that is in- tended to treat a serious or life-threatening infec- tion, the Secretary—

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117

‘‘(A) may execute a written agreement

with the sponsor on the process for developing data to support an application for approval of such drug, for use in a limited population of pa- tients in accordance with this subsection;

‘‘(B) shall proceed with the development and approval of such a drug in accordance with this subsection only if a written agreement is reached under subparagraph (A);

‘‘(C) shall provide the sponsor with an op- portunity to request meetings under paragraph (2);

‘‘(D) if a written agreement is reached under subparagraph (A), may approve the drug under this subsection for such use —

‘‘(i) in a limited population of patients for which there is an unmet medical need; ‘‘(ii) based on a streamlined develop-

ment program; and

‘‘(iii) only if the standards for ap-

proval under subsections (c) and (d) of this section or licensure under section 351 of the Public Health Service Act, as applica- ble, are met; and

pg. 122

RULE OF CONSTRUCTION.—Nothing in

this subsection shall be construed—

‘‘(A) to alter the standards of evidence

under subsection (c) or (d) (including the sub- stantial evidence standard in subsection (d));

Pgs 122

‘‘(D) to restrict in any manner, the pre-

scribing of antibiotics or other products by health care providers, or to otherwise limit or restrict the practice of health care.

‘‘(8) EFFECTIVE IMMEDIATELY.—The Sec-

retary shall have the authorities vested in the Sec- retary by this subsection beginning on the date of enactment of this subsection, irrespective of when and whether the Secretary promulgates final regula- tions or guidance.

Pgs 124

1. (c) GUIDANCE.—Not later than 18 months after the

2. 16 date of enactment of this Act, the Secretary of Health and

3. 17 Human Services, acting through the Commissioner of

4. 18 Food and Drugs, shall issue draft guidance describing cri-

5. 19 teria, process, and other general considerations for dem-

6. 20 onstrating the safety and effectiveness of antibacterial and

7. 21 antifungal drugs to be approved for use in a limited popu-

8. 22 lation in accordance with section 505(z) of the Federal

9. 23 Food, Drug, and Cosmetic Act, as added by subsection

10. 24 (b).

pg 127

1. The ap-

2. 15 proval of any drugs under any such expansion shall be

3. 16 subject to the considerations and requirements described

4. 17 in such section 505(z) for purposes of expansion to other

5. 18 serious or life-threatening diseases or conditions.

Pg 127

‘‘SEC. 317U. MONITORING ANTIBACTERIAL AND

ANTIFUNGAL DRUG USE AND RESISTANCE.

‘‘(a) MONITORING.—The Secretary shall use an ap- propriate monitoring system to monitor—

1. ‘‘(1) the use of antibacterial and antifungal

2. 2 drugs, including those receiving approval or licensure

3. 3 for a limited population pursuant to section 505(z)

4. 4 of the Federal Food, Drug, and Cosmetic Act; and

5. 5 ‘‘(2) changes in bacterial and fungal resistance

6. 6 to drugs.

7. 7 ‘‘(b) PUBLIC AVAILABILITY OF DATA.—The Sec-

8. 8 retary shall make summaries of the data derived from

9. 9 monitoring under this section publicly available for the

10. 10 purposes of—

11. 11 ‘‘(1) improving the monitoring of important

12. 12 trends in antibacterial and antifungal resistance;

13. 13 and

14. 14 ‘‘(2) ensuring appropriate stewardship of anti-

15. 15 bacterial and antifungal drugs, including those re-

16. 16 ceiving approval or licensure for a limited population

17. 17 pursuant to section 505(z) of the Federal Food,

18. 18 Drug, and Cosmetic Act.’’.

pgs. 129

1. ‘‘SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY

2. 2 TEST INTERPRETIVE CRITERIA FOR MICRO-

3. 3 ORGANISMS.

4. 4 ‘‘(a) PURPOSE; IDENTIFICATION OF CRITERIA.—

5. 5 ‘‘(1) PURPOSE.—The purpose of this section is

6. 6 to provide the Secretary with an expedited, flexible

7. 7 method for—

‘‘(A) clearance or premarket approval of antimicrobial susceptibility testing devices uti- lizing updated, recognized susceptibility test in- terpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms to antimicrobial drugs; and

pg 130

1. ‘(3) BASES FOR INITIAL IDENTIFICATION.—

2. 7 The Secretary shall identify appropriate suscepti-

3. 8 bility test interpretive criteria under paragraph (2),

4. 9 based on the Secretary’s review of, to the extent

5. 10 available and relevant—

6. ‘‘(A) preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epide- miological data;

7. ‘‘(B) Bayesian and pharmacometric statis- tical methodologies; and

8. ‘‘(C) such other evidence and information as the Secretary considers appropriate.

‘(2) LISTING OF SUSCEPTIBILITY TEST INTER- PRETIVE CRITERIA STANDARDS.—

‘‘(A) IN GENERAL.—The list described in paragraph (1) shall consist of any new or up- dated susceptibility test interpretive criteria standards that are—

‘‘(i) established by a nationally or internationally recognized standard devel- opment organization that—

‘‘(I) establishes and maintains procedures to address potential con- flicts of interest and ensure trans- parent decisionmaking;

‘‘(II) holds open meetings to en- sure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and

‘‘(III) permits its standards to be made publicly available, through the National Library of Medicine or an-

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131

interpretive criteria standards in accordance with

paragraph (2) (referred to in this section as the ‘In- terpretive Criteria Website’).

‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTER- PRETIVE CRITERIA STANDARDS.—

‘‘(A) IN GENERAL.—The list described in paragraph (1) shall consist of any new or up- dated susceptibility test interpretive criteria standards that are—

‘‘(i) established by a nationally or internationally recognized standard devel- opment organization that—

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other similar source acceptable to the Secretary; and

‘‘(ii) recognized in whole, or in part,

by the Secretary under subsection (c).

‘‘(B) OTHER LIST.—The Interpretive Cri- teria Website shall, in addition to the list de- scribed in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed

antimicrobial drugs, where—

‘‘(i) the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph (A) otherwise applicable to such a drug;

‘‘(ii) the Secretary withdraws under subsection (c)(1)(B) recognition of a standard, in whole or in part, otherwise applicable to such a drug;

‘‘(iii) the Secretary approves an appli- cation under section 505 of this Act or sec- tion 351 of the Public Health Service Act, as applicable, with respect to marketing of such a drug for which there are no rel- evant interpretive criteria included in a

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standard recognized by the Secretary under subsection (c); or

‘‘(iv) because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug—

‘‘(I) differ from otherwise appli- cable interpretive criteria included in a standard listed under subparagraph (A) or interpretive criteria otherwise listed under this subparagraph; and

‘‘(II) are determined by the Sec- retary to be appropriate for the drug.

teria Website shall include the following: ‘‘(i) A statement that—

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‘‘(I) the website provides infor- mation about the susceptibility of bac- teria, fungi, or other microorganisms to a certain drug (or drugs); and

‘‘(II) the safety and efficacy of the drug in treating clinical infections due to such bacteria, fungi, or other microorganisms may not have been es-

1. tablished in adequate and well-con-

2. 2 trolled clinical trials and the clinical

3. 3 significance of such susceptibility in-

4. 4 formation in such trials is unknown.

5. 5 ‘‘(ii) A statement that directs health

6. 6 care practitioners to consult the approved

7. 7 product labeling for specific drugs to deter-

8. 8 mine the uses for which the Food and

9. 9 Drug Administration has approved the

10. 10 product.

11. 11 ‘‘(iii) Any other statement that the

12. 12 Secretary determines appropriate to ade-

13. 13 quately convey the limitations of the data

14. 14 supporting susceptibility test interpretive

15. 15 criteria standard listed on the website.

16. 16 ‘‘(3) NOTICE.—Not later than the date on

17. 17 which the Interpretive Criteria Website is estab-

18. 18 lished, the Secretary shall publish a notice of that

19. 19 establishment in the Federal Register.

20. 20 ‘‘(4) INAPPLICABILITY OF MISBRANDING PROVI-

21. 21 SION.—The inclusion in the approved labeling of an

22. 22 antimicrobial drug of a reference or hyperlink to the

23. 23 Interpretive Criteria Website, in and of itself, shall

24. 24 not cause the drug to be misbranded in violation of

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‘‘(A) evaluate any appropriate new or up- dated susceptibility test interpretive criteria standards established by a nationally or inter- nationally recognized standard development or- ganization described in subsection (b)(2)(A)(i); and

‘‘(B) publish on the public website of the Food and Drug Administration a notice—

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135

1. 1 section 502, or the regulations promulgated there-

2. 2 under.

3. 3 ‘‘(5) TRADE SECRETS AND CONFIDENTIAL IN-

4. 4 FORMATION.—Nothing in this section shall be con-

5. 5 strued as authorizing the Secretary to disclose any

6. 6 information that is a trade secret or confidential in-

7. 7 formation subject to section 552(b)(4) of title 5,

8. 8 United States Code.

9. ‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTER-

10. 10 PRETIVE CRITERIA FROM STANDARD DEVELOPMENT OR-

11. 11 GANIZATIONS.—

12. ‘‘(1) IN GENERAL.—Beginning on the date of

13. 13 the establishment of the Interpretive Criteria

14. 14 Website, and at least every 6 months thereafter, the

15. 15 Secretary shall—

‘(A) evaluate any appropriate new or up- dated susceptibility test interpretive criteria standards established by a nationally or inter- nationally recognized standard development or- ganization described in subsection (b)(2)(A)(i); and

‘‘(B) publish on the public website of the Food and Drug Administration a notice—

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135 - 136

1. 1 section 502, or the regulations promulgated there-

2. 2 under.

3. 3 ‘‘(5) TRADE SECRETS AND CONFIDENTIAL IN-

4. 4 FORMATION.—Nothing in this section shall be con-

5. 5 strued as authorizing the Secretary to disclose any

6. 6 information that is a trade secret or confidential in-

7. 7 formation subject to section 552(b)(4) of title 5,

8. 8 United States Code.

9. 9 ‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTER-

10. 10 PRETIVE CRITERIA FROM STANDARD DEVELOPMENT OR-

11. 11 GANIZATIONS.—

12. 12 ‘‘(1) IN GENERAL.—Beginning on the date of

13. 13 the establishment of the Interpretive Criteria

14. 14 Website, and at least every 6 months thereafter, the

15. 15 Secretary shall—

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136

1. 1 ‘‘(i) withdrawing recognition of any

2. 2 different susceptibility test interpretive cri-

3. 3 teria standard, in whole or in part;

4. 4 ‘‘(ii) recognizing the new or updated

5. 5 standards;

6. 6 ‘‘(iii) recognizing one or more parts of

7. 7 the new or updated interpretive criteria

8. 8 specified in such a standard and declining

9. 9 to recognize the remainder of such stand-

10. 10 ard; and

11. 11 ‘‘(iv) making any necessary updates to

12. 12 the lists under subsection (b)(2).

Pg. 136

10. ‘(2) BASES FOR UPDATING INTERPRETIVE CRI-

11. 14 TERIA STANDARDS.—In evaluating new or updated

12. 15 susceptibility test interpretive criteria standards

13. 16 under paragraph (1)(A), the Secretary may con-

14. 17 sider—

18 19 20 21 22 23 24

‘‘(A) the Secretary’s determination that such a standard is not applicable to a particular drug because the characteristics of the drug dif- fer from other drugs with the same active in- gredient;

‘‘(B) information provided by interested third parties, including public comment on the

‘‘(C) any bases used to identify suscepti-

bility test interpretive criteria under subsection (a)(2); and

‘‘(D) such other information or factors as the Secretary determines appropriate.

‘‘(3) ANNUAL COMPILATION OF NOTICES.—

Each year, the Secretary shall compile the notices published under paragraph (1)(B) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary will review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive cri- teria standards—

‘‘(A) recognized by the Secretary under this subsection; or

‘‘(B) otherwise listed on the Interpretive Criteria Website under subsection (b)(2).

‘‘(4) RELATION TO SECTION 514(c).—Any sus-

ceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be

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recognized as a standard by the Secretary under sec-

tion 514(c)(1).

WHERE HAVE WE SEEN THIS BEFORE- VOLUNTARY, YEAH, RIGHT!

‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRI-

TERIA.—Nothing in this section prohibits a person from seeking approval or clearance of a drug or de- vice, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria stand- ards which differ from those recognized pursuant to paragraph (1).

‘‘(d) ANTIMICROBIAL DRUG LABELING.—

‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISH- MENT OF INTERPRETIVE CRITERIA WEBSITE.—With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate com- merce for commercial distribution before the estab- lishment of the Interpretive Criteria Website, a hold- er of an approved application under section 505 or section 351 of the Public Health Service Act, as ap-

plicable, for each such drug—

‘‘(A) not later than 1 year after establish-

ment of the Interpretive Criteria Website, shall submit to the Secretary a supplemental applica- tion for purposes of changing the drug’s label- ing to substitute a reference or hyperlink to

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139

1. 1 such Website for any susceptibility test inter-

2. 2 pretive criteria and related information; and

3. 3 ‘‘(B) may begin distribution of the drug in-

4. 4 volved upon receipt by the Secretary of the sup-

5. 5 plemental application for such change.

6. 6 ‘‘(2) DRUGS MARKETED SUBSEQUENT TO ES-

7. 7 TABLISHMENT OF INTERPRETIVE CRITERIA

8. 8 WEBSITE.—With respect to antimicrobial drugs law-

9. 9 fully introduced or delivered for introduction into

10. 10 interstate commerce for commercial distribution on

11. 11 or after the date of the establishment of the Inter-

12. 12 pretive Criteria Website, the labeling for such a drug

13. 13 shall include, in lieu of susceptibility test interpretive

14. 14 criteria and related information, a reference to such

15. 15 Website.

16. 16 ‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTI-

17. 17 MICROBIAL SUSCEPTIBILITY TESTING DEVICES.—

18. 18 ‘‘(1) IN GENERAL.—Notwithstanding sections

19. 19 501, 502, 510, 513, and 515, if the conditions speci-

20. 20 fied in paragraph (2) are met (in addition to other

21. 21 applicable provisions under this chapter) with re-

22. 22 spect to an antimicrobial susceptibility testing device

23. 23 described in subsection (f)(1), the Secretary may au-

24. 24 thorize the marketing of such device for a use de-

25. 25 scribed in such subsection.

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‘‘(I) the device provides informa- tion about the susceptibility of bac- teria and fungi to certain drugs; and

‘‘(II) the safety and efficacy of such drugs in treating clinical infec- tions due to such bacteria or fungi may not have been established in ade- quate and well-controlled clinical trials and the clinical significance of such

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140

‘‘(2) CONDITIONS APPLICABLE TO ANTI-

MICROBIAL SUSCEPTIBILITY TESTING DEVICES.— The conditions specified in this paragraph are the following:

‘‘(A) The device is used to make a deter- mination of susceptibility using susceptibility test interpretive criteria that are—

‘‘(i) included in a standard recognized by the Secretary under subsection (c); or

‘‘(ii) otherwise listed on the Interpre- tive Criteria Website under subsection (b)(2).

‘‘(iii) includes any other statement the Secretary determines appropriate to ade- quately convey the limitations of the data supporting the interpretive criteria de- scribed in subparagraph (A).

‘‘(f) DEFINITIONS.—In this section: (HOPKINS NEWLY DISCOVERED TEST)

‘‘(1) The term ‘antimicrobial susceptibility test-

ing device’ means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).

‘‘(2) The term ‘qualified infectious disease product’ means a qualified infectious disease product designated under section 505E(d).

‘‘(3) The term ‘susceptibility test interpretive criteria’ means—

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142

‘‘(A) one or more specific numerical values

which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and ‘‘(B) related categorizations of such sus- ceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appro-

priate.

‘(4)(A) The term ‘antimicrobial drug’ means, subject to subparagraph (B), a systemic anti- bacterial or antifungal drug that—

‘‘(i) is intended for human use in the treat- ment of a disease or condition caused by a bac- terium or fungus;

‘‘(ii) may include a qualified infectious dis- ease product designated under section 505E(d); and

‘‘(iii) is subject to section 503(b)(1).

‘‘(B) If provided by the Secretary through regu-

lations, such term may include—

‘‘(i) drugs other than systemic anti-

bacterial and antifungal drugs; and

‘‘(ii) biological products (as such term is

defined in section 351 of the Public Health

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1 2

3. 3 ‘‘(g)

4. 4 tion shall

5 6 7 8 9

143

Service Act) to the extent such products exhibit

antimicrobial activity.

RULE OF CONSTRUCTION.—Nothing in this sec- be construed—

‘‘(1) to alter the standards of evidence—

‘‘(A) under subsection (c) or (d) of section 505, including the substantial evidence stand- ard in section 505(d), or under section 351 of the Public Health Service Act (as applicable); or

‘‘(B) with respect to marketing authoriza- tion for devices, under section 510, 513, or 515; ‘‘(2) to apply with respect to any drug, device,

10 11 12 13

14. 14 or biological product, in any context other than—

15. 15 ‘‘(A) an antimicrobial drug; or

16. 16 ‘‘(B) an antimicrobial susceptibility testing

17. 17 device that uses susceptibility test interpretive

18. 18 criteria to characterize and report the in vitro

19. 19 susceptibility of certain bacteria, fungi, or other

20. 20 microorganisms to antimicrobial drugs in ac-

21. 21 cordance with this section; or

22. 22 ‘‘(3) unless specifically stated, to have any ef-

23. 23 fect on authorities provided under other sections of

24. 24 this Act, including any regulations issued under such

25. 25 sections.’’.

1. 7 (2) MISBRANDING.—Section 502 of the Federal

2. 8 Food, Drug, and Cosmetic Act (21 U.S.C. 352), as

3. 9 amended by section 2121, is further amended by

4. 10 adding at the end the following:

5. 11 ‘‘(ee) If it is an antimicrobial drug and its labeling

6. 12 fails to conform with the requirements under section

7. 13 511(d).’’.

8. 14 (3) RECOGNITION OF INTERPRETIVE CRITERIA

9. 15 AS DEVICE STANDARD.—Section 514(c)(1)(A) of the

10. 16 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

11. 17 360d(c)(1)(A)) is amended by inserting after ‘‘the

12. 18 Secretary shall, by publication in the Federal Reg-

13. 19 ister’’ the following: ‘‘(or, with respect to suscepti-

14. 20 bility test interpretive criteria or standards recog-

15. 21 nized or otherwise listed under section 511, by post-

16. 22 ing on the Interpretive Criteria Website in accord-

17. 23 ance with such section)’’.

18. 24 (c) REPORT TO CONGRESS.—Not later than two

19. 25 years after the date of enactment of this Act, the Sec-

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145

1. 1 retary of Health and Human Services shall submit to the

2. 2 Committee on Energy and Commerce of the House of

3. 3 Representatives and the Committee on Health, Education,

4. 4 Labor and Pensions of the Senate a report on the progress

5. 5 made in implementing section 511 of the Federal Food,

6. 6 Drug, and Cosmetic Act (21 U.S.C. 360a), as amended

7. 7 by this section.

8. 8 (d) REQUESTS FOR UPDATES TO INTERPRETIVE CRI-

9. 9 TERIA WEBSITE.—Chapter 35 of title 44, United States

10. 10 Code, shall not apply to the collection of information from

11. 11 interested parties regarding the updating of lists under

12. 12 paragraph (2) of subsection (b) section 511 of the Federal

13. 13 Food, Drug, and Cosmetic Act (as amended by subsection

14. 14 (a)) and posted on the Interpretive Criteria Website estab-

15. 15 lished under paragraph (1) of such subsection (b).

Pg 145

1. (e) NO EFFECT ON HEALTH CARE PRACTICE.—

2. 17 Nothing in this subtitle (including the amendments made

3. 18 by this subtitle) shall be construed to restrict, in any man-

4. 19 ner, the prescribing or administering of antibiotics or

5. 20 other products by health care practitioners, or to limit the

6. 21 practice of health care.

1. ‘‘(bb) meets the definition of a qualified in-

2. 7 fectious disease product under section 505E(g)

3. 8 of the Federal Food, Drug, and Cosmetic Act;

‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— The term ‘qualified infectious disease product’ means an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by—

TAM12092

1 2 3 4 5 6 7 8 9

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Draft S.L.C. 7

‘‘(1) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or

‘‘(2) qualifying pathogens listed by the Sec- retary under subsection (f).’’.

(b) APPLICATION.—Section 505E of the Federal

Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to a drug that is first ap- proved under section 505(c) of such Act (21 U.S.C. 355(c)) on or after the date of the enactment of this Act. Etc. etc. etc……

http://www.help.senate.gov/imo/media/audio/032912_DRAFT_Antib_TAM12092.pdf

1. ‘‘(II) is intended to treat an infection for which

2. 10 there is an ‘unmet medical need’; and

3. 11 ‘‘(III) is intended to treat an infection associ-

4. 12 ated with high rates of mortality or significant pa-

5. 13 tient morbidity, as determined in consultation with

6. 14 the infectious disease professional community.

1. ‘(iii) For purposes of this subparagraph, the term

2. 16 ‘eligible hospital’ means a hospital that participates in the

3. 17 National Healthcare Safety Network of the Centers for

4. 18 Disease Control and Prevention (or, to the extent a similar

5. 19 surveillance system reporting program that includes re-

6. 20 porting about antimicrobial drugs is determined by the

7. 21 Secretary to be available to such hospitals, such similar

8. 22 surveillance system as the Secretary may specify).

9. 23 ‘‘(iv) The Secretary may only revoke a determination

10. 24 of a product under this subparagraph as a new anti-

11. 25 microbial drug if the Secretary finds that the request for

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148

1. 1 such determination contained an untrue statement of ma-

2. 2 terial fact.

3. 3 ‘‘(v) Not later than October 1, 2017, the Secretary

4. 4 shall first publish in the Federal Register a list of the new

5. 5 antimicrobial drugs. Each fiscal year thereafter, the Sec-

6. 6 retary shall publish a list of the new antimicrobial drugs

7. 7 for such fiscal year as part of the annual rulemaking

8. 8 under this subsection.

9. 9 ‘‘(vi)(I) The total of the additional payments made

10. 10 under this subsection pursuant to this subparagraph for

11. 11 discharges in a fiscal year (as estimated by the Secretary

12. 12 as part of the rulemaking under this subsection for the

13. 13 fiscal year) may not exceed the applicable percentage

14. 14 (specified in subclause (II)) of the total program payments

15. 15 estimated to be made under this subsection for all dis-

16. 16 charges in such fiscal year (as calculated by the Secretary

17. 17 as part of the rulemaking under this subsection for the

18. 18 fiscal year). For purposes of the preceding sentence, in

19. 19 the case that, with respect to a fiscal year, such additional

20. 20 payments are made only with respect to discharges during

21. 21 a portion of such fiscal year, the reference to ‘all dis-

22. 22 charges in such fiscal year’ shall be considered a reference

23. 23 to all discharges during such portion of such fiscal year.

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(2) CONFORMING AMENDMENTS.—

(A) NO DUPLICATIVE NTAP PAYMENTS.—

Section 1886(d)(5)(K)(i) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)(i)) is amend- ed by inserting ‘‘and with respect to which an additional payment is not made pursuant to subparagraph (M),’’ after ‘‘2001,’’.

(B) ACCESS TO PRICE INFORMATION.— Section 1927(b)(3)(A)(iii) of the Social Security Act (42 U.S.C. 1396r–8(b)(3)(A)(iii)) is amended—

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149

1. 1 ‘‘(II) For purposes of subclause (I), the term ‘appli-

2. 2 cable percentage’ means, for fiscal year 2018 and each fis-

3. 3 cal year thereafter, 0.06807 percent.

4. ‘‘(III) If the Secretary estimates before the beginning

5. 5 of a fiscal year that the amount of the additional payments

6. 6 under this subsection pursuant to this subparagraph for

7. 7 the fiscal year (or portion thereof) as determined under

8. 8 subclause (I) will exceed the limit established under such

9. 9 subclause, the Secretary shall reduce pro rata the amount

10. 10 of each of the additional payments under this subsection

11. 11 pursuant to this subparagraph for such fiscal year (or por-

12. 12 tion thereof) in order to ensure that the aggregate addi-

13. 13 tional payments under this subsection pursuant to this

14. 14 paragraph (as so estimated) do not exceed such limit.’’.

15. 9 (b) STUDY AND REPORT ON REMOVING BARRIERS TO

16. 10 DEVELOPMENT OF NEW ANTIMICROBIAL DRUGS.—

17. 11 (1) STUDY.—The Comptroller General of the

18. 12 United States shall conduct a study to—

19. 13 (A) identify and examine the barriers that

20. 14 prevent the development of new antimicrobial

21. 15 drugs, as defined in section 1886(d)(5)(M)(iii)

22. 16 of the Social Security Act (42 U.S.C.

23. 17 1395ww(d)(5)(M)(iii)); and

24. 18 (B) develop recommendations for actions

25. 19 to be taken in order to overcome any barriers

26. 20 identified under subparagraph (A).

27. 21 (2) CONSIDERATION.—In conducting such

28. 22 study, the Comptroller General shall take into ac-

29. 23 count the perspectives of the Director of the Na-

30. 24 tional Institutes of Health, the Commissioner of the

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151

Food and Drugs, and the Director of the Centers for

Disease Control and Prevention.

(3) REPORT.—Not later than 1 year after the

date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under paragraph (1).

Subtitle H—Vaccine Access, Certainty, and Innovation

vation

(What they could not pass in individual states is being tossed into this bill to get all states to comply with mandatory vaccines)

SEC. 2141. TIMELY REVIEW OF VACCINES BY THE ADVISORY

COMMITTEE ON IMMUNIZATION PRACTICES.

Section 2102(a) of the Public Health Service Act (42 U.S.C. 300aa–2(a)) is amended by adding at the end the following:

‘‘(10) ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES.—

‘‘(A) STANDARD PERIODS OF TIME FOR MAKING RECOMMENDATIONS.—Upon the licen- sure of any vaccine or any new indication for a vaccine, the Director of the Program shall di- rect the Advisory Committee on Immunization Practices, at its next regularly scheduled meet- ing, to consider the use of the vaccine.

‘‘(B) EXPEDITED REVIEW PURSUANT TO REQUEST BY SPONSOR OR MANUFACTURER.—If the Advisory Committee does not make rec-

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152

ommendations with respect to the use of a vac-

cine at the Advisory Committee’s first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee, at the request of the sponsor of the vaccine, shall make such rec- ommendations on an expedited basis.

‘‘(C) EXPEDITED REVIEW FOR BREAK- THROUGH THERAPIES AND FOR USE DURING PUBLIC HEALTH EMERGENCIES.—If a vaccine is designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act and is licensed under section 351 of this Act, the Advisory Committee shall make recommendations with respect to the use of the vaccine on an expedited basis.

‘‘(D) DEFINITION.—In this paragraph, the terms ‘Advisory Committee on Immunization Practices’ and ‘Advisory Committee’ mean the advisory committee on immunization practices established by the Secretary pursuant to section 222, acting through the Director of the Centers for Disease Control and Prevention.’’.

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SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF ACIP RECOMMENDATIONS.

(a) REVIEW.—The Director of the Centers for Dis- ease Control and Prevention shall conduct a review of the process used by the Advisory Committee on Immunization Practices to evaluate consistency in formulating and issuing recommendations pertaining to vaccines.

(b) CONSIDERATIONS.—The review under subsection (a) shall include assessment of—

(1) the criteria used to evaluate new and exist- ing vaccines;

(2) the Grading of Recommendations, Assess- ment, Development, and Evaluation (GRADE) ap- proach to the review and analysis of scientific and economic data, including the scientific basis for such approach; and

(3) the extent to which the processes used by the working groups of the Advisory Committee on Immunization Practices are consistent among groups.

(c) STAKEHOLDERS.—In carrying out the review

under subsection (a), the Director of the Centers for Dis- ease Control and Prevention shall solicit input from vac- cine stakeholders.

(d) REPORT.—Not later than 18 months after the date of enactment of this Act, the Director of the Centers

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for Disease Control and Prevention shall submit to the

appropriate committees of the Congress and make publicly available a report on the results of the review under sub- section (a), including recommendations on improving the consistency of the process described in such subsection.

(e) DEFINITION.—In this section, the term ‘‘Advisory Committee on Immunization Practices’’ means the advi- sory committee on immunization practices established by the Secretary of Health and Human Services pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Dis- ease Control and Prevention.

SEC. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVEL-

OPERS.

Section 310 of the Public Health Service Act (42 U.S.C. 242o) is amended by adding at the end the fol- lowing:

‘‘(c)(1) In this subsection, the term ‘vaccine devel- oper’ means a nongovernmental entity engaged in—

‘‘(A)(i) the development of a vaccine with the intent to pursue licensing of the vaccine by the Food and Drug Administration; or

‘‘(ii) the production of a vaccine licensed by the Food and Drug Administration; and

‘‘(B) vaccine research.

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‘‘(i) the Food and Drug Administration; and

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1. 1 ‘‘(2)(A) Upon the submission of a written request for

2. 2 a meeting by a vaccine developer, that includes a justifica-

3. 3 tion for the meeting, the Secretary, acting through the Di-

4. 4 rector of the Centers for Disease Control and Prevention,

5. 5 shall convene a meeting of representatives of the vaccine

6. 6 developer and experts from the Centers for Disease Con-

7. 7 trol and Prevention in immunization programs, epidemi-

8. 8 ology, and other relevant areas at which the Director (or

9. 9 the Director’s designee), for the purpose of informing the

10. 10 vaccine developer’s understanding of public health needs

11. 11 and priorities, shall provide the perspectives of the Centers

12. 12 for Disease Control and Prevention and other relevant

13. 13 Federal agencies regarding—

1. ‘‘(i) public health needs, epidemiology, and im-

2. 15 plementation considerations with regard to a vaccine

3. 16 developer’s potential vaccine profile; and

4. 17 ‘‘(ii) potential implications of such perspectives

5. 18 for the vaccine developer’s vaccine research and de-

6. 19 velopment planning.

7. 20 ‘‘(B) In addition to the representatives specified in

8. 21 subparagraph (A), the Secretary may, with the agreement

9. 22 of the vaccine developer requesting a meeting under such

10. 23 subparagraph, include in such meeting representatives

11. 24 of—

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‘‘(ii) the National Vaccine Program.

‘‘(C) The Secretary shall convene a meeting re- quested under subparagraph (A) not later than 120 days after receipt of the request for the meeting.

‘‘(3)(A) Upon the submission of a written request by a vaccine developer, the Secretary, acting through the Di- rector of the Centers for Disease Control and Prevention, shall provide to the vaccine developer any age-based or other demographically assessed disease epidemiological analyses or data that—

‘‘(i) are specified in the request;

‘‘(ii) have been published;

‘‘(iii) have been performed by or are in the pos-

session of the Centers;

‘‘(iv) are not a trade secret or commercial or fi-

nancial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code; and

‘‘(v) do not contain individually identifiable in- formation.

‘‘(B) The Secretary shall provide analyses requested by a vaccine manufacturer under subparagraph (A) not later than 120calendar days after receipt of the request for the analyses.

157

‘‘(4) The Secretary shall promptly notify a vaccine

developer if—

‘‘(A) the Secretary becomes aware of any

change to information that was—

‘‘(i) shared by the Secretary with the vac-

cine developer during a meeting under para- graph (2); or

‘‘(ii) provided by the Secretary to the vac- cine developer in one or more analyses under paragraph (3); and

‘‘(B) the change may have implications for the

vaccine developer’s vaccine research and develop-

ment.’’.

STOPPED TAKING NOTES HERE- pg. 157

http://docs.house.gov/meetings/IF/IF00/20150519/103516/BILLS-1146ih.pdf