Cures 21st Century

UPDATE-  December 13, 2016
President Obama Signs 21 Century Cures Act


Video



Articles







UPDATE- December 7, 2016 6:00 PM
Cures Act Bill Passes Senate- On Its Way to President for Signature

Congressional members are still making minor language adjustments to the Cures Act as I write this (Wed. 6 PM).  The final language will not be published until the last of the negotiations are completed, possibly tonight or tomorrow.  

It APPEARS, from what I was told, that what some consider to be the more helpful Lyme/TBD language was left in tact, but the Congressional liaison couldn’t say for sure as they are still working on it.  

Here are some of the first news reports.

QUOTE-  "The Senate voted 94-5 on Wednesday to approve the bill, the 21st Century Cures Act, which will hasten how drugs and medical devices are reviewed and authorized by the Food and Drug Administration. The measure also provides funding for efforts like Obama's Precision Medicine Initiative and Vice President Joe Biden's "Cancer Moonshot," as well as money for Alzheimer's research…. 

Senate Majority Leader Mitch McConnell, R-Ky., has called the Cures Act the most important piece of legislation Congress would handle this year. Supporters of the bill included medical device and drug companies, medical schools, hospitals and doctors."


QUOTE-  "Approximately 420 organizations lobbied for the Cures bill, according to the The Center for Responsive Politics, including Blue Cross/Blue Shield, Roche, Amgen, and the Pharmaceutical Research & Manufacturers of America, the industry's major trade association."


Another Article



UPDATE-  December 6, 2016
Another LONG day listening to the Senate hearing on many topics and still no vote.  Stay tuned. On Wednesday, 12/7/16, the hearing will resume.  To listen to the proceedings, click on this link.  

UPDATE-  December 5, 2016
Watch Senate Live Today- Tuesday- to see the Senate bill hearing.  LDA posted the information at its site- www.LymeDiseaseAssociation.org  


This is the page on the government site that will be the one to watch to see Senate live streaming video.   http://www.senate.gov/floor/index.htm

Here is the bill language.  https://www.congress.gov/114/bills/hr34/BILLS-114hr34eah.pdf

UPDATE-  Well, butter my biscuits, I think we've got the final wording.  And it is looking good!  

It is as close as I can remember to the Lyme Disease Association's original bills that they've worked so hard on for so many years (decades, in fact).  Pat Smith, President of the LDA, should be congratulated!  Nothing less than your full appreciation and thanks to her is acceptable.

[Attached to the very bottom of this page is a Word document with a copy of the bill language in PDF format.  Please feel free to copy and share it.]

December 2, 2016

From the Lyme Disease Association, Inc. Newsletter, 12/1/16-  Ground Breaking News: Bill Language Included to Help Lyme Patients! 

The LDA provided 2 links in its Newsletter late last night. According to the LDA, if the material at both links were combined it would provide the final bill wording.  Below is the result of my attempt to combine the two documents into one. 

The not black font indicates an addition was made to the previous version of the bill.  Crossed through bold language is what was removed.


SEC. 2062. TICK-BORNE DISEASES.

 

(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as ‘‘the Secretary’’) may shall continue to conduct or support epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases.

 

(b) REPORTS.—The Secretary shall ensure that each triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032) includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to tick-borne diseases. 

 

(c) TICK-BORNE DISEASES WORKING GROUP.—


(1) E
STABLISHMENT.—The Secretary may shall establish a working group, to be known as the Tick- Borne Disease Working Group (referred to in this section as the ‘‘Working Group’’), comprised of representatives of appropriate Federal agencies and other non-Federal entities, as appropriate, to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities.


(2) R
ESPONSIBILITIES.—The working group shall—

(A) not later than 2 years after the date of enactment of this Act, develop or update a summary of— ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick- borne diseases;

 

(ii) advances made pursuant to such research;

 

(iii) Federal activities related to tick- borne diseases, including—

 

(I) epidemiological activities related to tick-borne diseases; and

 

(II) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;

 

(iv) gaps in tick-borne disease research described in clause (iii)(II);

 

(v) the Working Group’s meetings required under paragraph (4); and

 

(vi) the comments received by the Working Group;

 

(B) make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research;

and

(C) solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.

 

(3) MEMBERSHIP.—The members of the working group shall represent a diversity of scientific disciplines.

 

(3) MEMBERSHIP.—The members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members:

 

(A) FEDERAL MEMBERS.—Seven Federal members, consisting of one or more representatives of each of the following:

 

(i) The Office of the Assistant Secretary for Health.

(ii) The Food and Drug Administration.

(iii) The Centers for Disease Control and Prevention.

(iv) The National Institutes of Health.

(v) Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate.

(B) NON–FEDERAL PUBLIC MEMBERS.—

Seven non–Federal public members, consisting of representatives of the following categories:

 

(i) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases.

(ii) Scientists or researchers with expertise.

(iii) Patients and their family members.

(iv) Nonprofit organizations that advocate for patients with respect to tick-borne diseases.

(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.

 

(4) MEETINGS.—The Working Group shall meet not less than twice each year.

 

(5) REPORTING.—Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (6) Paragraph (7), the Working Group shall—

 

(A) submit a report on its activities under paragraph (2)(A) and any recommendations under paragraph (2)(B) to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate; and

(B) make such report publicly available on the Internet website of the Department of Health and Human Services.

 

(6) APPLICABILITY OF FACA.—The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.).

(6)  (7) SUNSET.—The Working Group under this section shall terminate 6 years after the date of enactment of this Act.

 

The End.

 

Sources For Two, Two, Two Doc U Mints In One!

http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf

http://amendments-rules.house.gov/amendments/UptonCURES112916152701271.pdf


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