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The 21st Century Cures Act

Location: US
Title: The 21st Century Cures Act
Identifier: HR 6/HR 34
Stance: OPPOSE
Action Required: None at this time
Status: Signed by Pres. Obama on 12/13/16

Description:

UPDATE: 12/13/2016 - President Obama signed HR 34, The 21st Century Cures Act on 12/14/2016.

UPDATE: 12/8/2016 - The following press release was issued by NVIC on 12/8/2016 -  http://www.businesswire.com/news/home/20161208005224/en 

UPDATE: 12/7/2016 - HR 34 passed the senate by a vote of 94 yes and 5 no.  Senators voting NO were, Sanders, Warren, Wyden Merkley and Lee. 

https://www.govtrack.us/congress/votes/114-2016/s157?utm_campaign=govtrack_feed&utm_source=govtrack/feed&utm_medium=rss - vote on HR 34


UPDATE: 12/6/2016 - HR 34 is scheduled to be considered tomorrow by the full senate, beginning at 9:30 a.m. EST. 

http://www.senate.gov/floor/ 

Schedule for Wednesday, Dec 07, 2016
9:30 a.m.: Convene and resume consideration of H.R.34, 21st Century Cures Act.

UPDATE 12/5/2016.  The Senate voted in favor of invoking cloture on HR 34 (17 no votes) which puts a time limit on debate (see below). With such a limited time on debate, it is highly unlikely any amendments to the current text of the bill will be accepted.  The vote on the motion for unanimous consent did not occur today and may happen tomorrow.  This would block any remaining debate.  With limited debate certain, and no amendments accepted a very highly likely outcome, we urge people to ask their senators to vote no on HR 34. 

UPDATE: 12/2/2016 - On Dec. 1, 2016 Senator Mitch McConnell made a motion for unanimous consent and cloture in the senate of the amended version of HR 34, The 21st Century Cures Act, that passed the US House of Representatives on 11/30/16. This motion is posted in the Congressional Record, Vol. 162, No. 172.  According to this record, the vote is scheduled for Monday, December 5th at 5:30 PM.  

If the motion for unanimous consent passes then the bill will pass with no debate or possible amendments.  If cloture passes it will stop any possible filibuster and limit debate. 

The most current, engrossed version of the bill is available here - https://www.congress.gov/114/bills/hr34/BILLS-114hr34eah.pdf 

Unanimous Consent







From its beginning, the Senate has transacted much of its business by unanimous consent. The Senate's small size, few rules, and informality encouraged the rise of this practice. A single objection ("I object") blocks a unanimous consent request. Even several of the Senate's early rules incorporated unanimous consent provisions to speed the Senate's routine business.

Two types of unanimous consent are prevalent in today's Senate. Simple unanimous consent requests deal with noncontroversial matters, such as senators asking unanimous consent to dispense with the reading of amendments. Complex unanimous consent agreements establish a tailor-made procedure for considering virtually any kind of business that the Senate takes up. They are commonly brokered by the parties' floor leaders and managers. Two fundamental objectives of these accords are to limit debate and to structure the amendment process. As two Senate parliamentarians wrote in the Senate's volume of precedents: "Whereas Senate Rules permit virtually unlimited debate, and very few restrictions on the right to offer amendments, these [unanimous consent] agreements usually limit debate and the right of Senators to offer amendments."

The cloture rule–Rule 22–is the only formal procedure that Senate rules provide for breaking a filibuster. A filibuster is an attempt to block or delay Senate action on a bill or other matter. Under cloture, the Senate may limit consideration of a pending matter to 30 additional hours of debate.  

UPDATE: 11/30/2016 - HR 34, The 21st Century Cures Act, passed the US House of Representatives by a vote of 392 yes to 26 no.  The vote is available here - http://clerk.house.gov/evs/2016/roll592.xml 

Video of discussion and vote on the bill is available through CSPAN here - https://www.c-span.org/video/?419301-101/us-house-legislative-business 

The bill now goes to the US Senate for a vote.

The original bill passed in the house last year on July 10, 2015 as HR 6 .  NVIC issued a press release on July 22, 2015 and Barbara Loe Fisher released a referenced commentary in opposition to this legislation.  After stalling out, many of the provisions of HR 6 were broken up into several smaller bills.  Then over the Thanksgiving Holiday the legislation was reworked. 

The new version, which removes some sections from HR 6 and adds some new sections not in the original bill, was pushed through the US House of Representatives on Nov. 30, 2016 after being amended on to HR 34.  HR 34 was originally a bill that only addressed Tsunami Warning, Education, and Research.

Text of the HOUSE AMENDMENT TO THE SENATE AMENDMENT TO H.R. 34, TSUNAMI WARNING, EDUCATION, AND RESEARCH ACT OF 2015 [Showing the text of the 21st Century Cures Act.]  is available here -  http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf 

News articles:

http://www.vox.com/2016/11/30/13792732/21st-century-cures-act-warren-sanders

https://www.statnews.com/2016/11/30/21st-century-cures-act-house/

http://www.healthcare-informatics.com/article/interoperability/us-house-passes-21st-century-cures-legislation

 

UPDATE: 11/30/2016 - The 21st Century Cures Act debate can be watched here - http://houselive.gov/MediaPlayer.php?view_id=23&event_id=92

UPDATE: 11/29/2016 - A reworked version of HR 6, The 21th Century Cures Act, was released over the Thanksgiving holiday weekend by Rep. Fred Upton, R-Mich., and Sen. Lamar Alexander, R-Tenn, according to this news article from US News .  The US House plans to vote on this bill on Wednesday, Nov. 30, 2016.  

Text of the new version is available here - http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf

This new version still contains many of the sections of concern that were in the original version outlined in Barbara Loe Fisher's commentary from 7/21/15, Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science . 

UPDATE: 9/14/2016  HR 6 has not moved since passing the US House and being referred in the Senate to the Committee on Health, Education, Labor, and Pensions.                                    































































































































































































































































HR 6 is a federal bill that has passed the US House and is now in the US Senate assigned to the Senate Committee on Health, Education, Labor and Pensions Committee. 

http://www.senate.gov/general/committee_membership/committee_memberships_SSHR.htm - Senate HELP Committee informaion

The bill is sponsored by Rep. Fred Upton (R) from Michigan and has 230 cosponsors. https://www.congress.gov/bill/114th-congress/house-bill/6/cosponsors 

https://www.congress.gov/bill/114th-congress/house-bill/6/actions - status and history for HR 6

The title of this bill is  An Act To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.  

This legislation includes a section that would fast track newly licensed vaccines for approval by the ACIP (Advisory Committee on Immunization Practices).  The ACIP makes recommendations for the use of vaccines, then states follow by requiring them or mandating them.  

In her commentary,  Barbara Loe Fisher says:

The 21st Century Cures Act is being sold as a way for the FDA to quickly license experimental pharmaceutical products for people suffering with rare or life threatening diseases, whether or not those products have been adequately tested.26 However, greasing the FDA licensure skids to make experimental drugs available for the sick and dying, who voluntarily choose to use them, is one thing, while greasing the skids to bum rush experimental vaccines to licensure that government will legally require healthy children and adults to buy and use, is something quite different.27 28 29 30 31

Nearly every single vaccine that the pharmaceutical industry creates and the FDA licenses for child use is eventually recommended for all children and mandated by state governments for daycare and school entry.32 33 34 35 36And, now, many adults are being brought into the vaccine mandate net as well.37 38 39

The 21st Century Cures Act is a prescription for disaster. Vaccine research, development and fast tracking should not be a part of it. 































































































































































































































































Watch and read Barbara Loe Fisher's full commentary on this legislation, Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science.  http://www.nvic.org/NVIC-Vaccine-News/July-2015/21st-century-cures-act-eliminates-good-science.aspx 

Read NVIC's press release here - http://www.enhancedonlinenews.com/news/eon/20150722006035/en/Vaccines/vaccination/CDC 

HR 6 adds the following new laws:

Full text of HR 6, vaccine section begins on page 162 - https://www.congress.gov/114/bills/hr6/BILLS-114hr6rfs.pdf 

subtitle H—Vaccine Access, Certainty, and Innovation































































































































































































































































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 licensure of any vaccine or any new indication for a vaccine, the Director of the Program shall direct the Advisory Committee on Immunization Practices, at its next regularly scheduled meeting, to consider the use of the vaccine.

“(B) EXPEDITED REVIEW PURSUANT TO REQUEST BY SPONSOR OR MANUFACTURER.—If the Advisory Committee does not make recommendations with respect to the use of a vaccine 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 recommendations on an expedited basis.

“(C) EXPEDITED REVIEW FOR BREAKTHROUGH 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.”.

SEC. 2142. Review of processes and consistency of ACIP recommendations.

(a) Review.—The Director of the Centers for Disease 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 existing vaccines;

(2) the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach 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 Disease Control and Prevention shall solicit input from vaccine stakeholders.

(d) Report.—Not later than 18 months after the date of enactment of this Act, the Director of the Centers 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 subsection (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 advisory 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 Disease Control and Prevention.

SEC. 2143. Meetings between CDC and vaccine developers.

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

“(c)(1) In this subsection, the term ‘vaccine developer’ 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.

“(2)(A) Upon the submission of a written request for a meeting by a vaccine developer, that includes a valid justification for the meeting, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall convene a meeting of representatives of the vaccine developer and experts from the Centers for Disease Control and Prevention in immunization programs, epidemiology, and other relevant areas at which the Director (or the Director’s designee), for the purpose of informing the vaccine developer’s understanding of public health needs and priorities, shall provide the perspectives of the Centers for Disease Control and Prevention and other relevant Federal agencies regarding—

“(i) public health needs, epidemiology, and implementation considerations with regard to a vaccine developer’s potential vaccine profile; and

“(ii) potential implications of such perspectives for the vaccine developer’s vaccine research and development planning.

“(B) In addition to the representatives specified in subparagraph (A), the Secretary may, with the agreement of the vaccine developer requesting a meeting under such subparagraph, include in such meeting representatives of—

“(i) the Food and Drug Administration; and

“(ii) the National Vaccine Program.

“(C) The Secretary shall convene a meeting requested with a valid justification 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 Director 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 possession of the Centers;

“(iv) are not a trade secret or commercial or financial 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 information.

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

“(4) The Secretary shall promptly notify a vaccine developer if—

“(A) the Secretary becomes aware of any significant change to information that was—

“(i) shared by the Secretary with the vaccine developer during a meeting under paragraph (2); or

“(ii) provided by the Secretary to the vaccine developer in one or more analyses under paragraph (3); and

“(B) the change to such information may have implications for the vaccine developer’s vaccine research and development.”.