House Amendment to Senate Amendment to H.R. 34, 21st Century Cures Act

H.Amdt. to S.Admt. to H.R. 34

21st Century Cures Act

Sponsor
Rep. Fred Upton

Date
November 30, 2016 (114th Congress, 2nd Session)

Staff Contact
Communications

Floor Situation

On Wednesday, November 30, 2016, the House will begin consideration of the House Amendment to Senate Amendment to H.R. 34, the 21st Century Cures Act, under a rule.  H.R. 34 was introduced on January 6, 2015, by Rep. Suzanne Bonamici (D-OR) as the Tsunami Warning, Education, and Research Act of 2015, and was referred to the Committee on Science, Space, and Technology. The bill passed the House on January 7, 2015 by voice vote. In the Senate, the Committee on Commerce, Science, and Transportation ordered the measure reported, as amended, on February 26, 2015, and H.R. 34 passed the Senate on October 6, 2015.

The Rules Committee Print strikes all after enacting clause and inserts the text of the 21st Century Cures Act, as recently negotiated between the House and Senate. The rule includes a self-executive Manager’s amendment that reallocates credits in accounts for the National Institutes of Health and Food and Drug Administration accounts, includes reductions in budget authority and transfers for NIH, FDA, and opioid accounts, and alters the scope of provisions eligible for FDA funding.  In addition, the Tick Borne strike and replace language changes the section from “may” to “shall” and adds a list of Federal and non-Federal members to be included in the working group.  The manager’s amendment codifies due process for determinations by the Secretary of Veteran’s Affairs and makes additional technical and conforming changes. Finally, the amendment strikes division D (Child and Family Services and Support).

Bill Summary

The Rules Committee Print of the Senate Amendment to H.R. 34 is designed to “modernize the health-care innovation infrastructure, incorporate a patient perspective into the drug and device approval process, support advances in personalized medicine, streamline clinical trials, and provide more resources to support cutting-edge research and help young scientists.”[1]  The bill seeks to speed and improve the discovery, development, and delivery of life-saving and life-improving therapies, and transform the quest for faster cures through:[2]

  • Innovation projects and state responses to opioid abuse;
  • Reauthorization of the National Institutes of Health;
  • Advancing precision medicine;
  • Supporting young and emerging scientists;
  • Modernizing clinical trials;
  • Removing regulatory uncertainty for the development of new medical apps;
  • Providing new incentives for the development of drugs for rare diseases and patient-focused drug development;
  • Facilitating collaborative research;
  • Medical device innovations; and
  • Investing in 21st Century science and next generation investigators.

In addition, the Rules Committee Print includes the text of H.R. 2646, the Helping Families in Mental Health Crisis Act of 2016, which passed the on July 6, 2016 by a vote of 422-2. The previous legislative digest for H.R. 2646 can be found here. It also makes changes to Medicare Part A and B, and includes the text of H.R. 5456, the Family First Prevention Services Act of 2016, which passed the House on June 21, 2016 by voice vote.

A comprehensive section-by-section can be found here. The previous Legislative Digest for H.R. 6 as passed by the House can be found here.

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[1] See Chairman Upton’s Op-ed—“How to Breathe New Life into America’s Health Care System,” June 4, 2015.
[2] See Fact Sheet—21st Century Cures Act (H.R. 6)

Background

Although science and technology have made tremendous advances in recent years, “our regulatory system has not kept pace with the innovation that is happening both in labs and in Silicon Valley.”[1]  The 21st Century has seen enormous advances in mobile medical apps and other technological tools, but the current regulatory system was established before many of these technologies even existed.  Consequently, the approval process for new drugs, therapies, and medical devices has lagged, while funding limitations have constrained medical and scientific research.  Today, there are only 500 treatments for 10,000 known diseases, 7,000 of which are considered rare.[2]

The National Institutes of Health (NIH), which is part of the Department of Health and Human Services (HHS), “is the nation’s medical research agency—making important discoveries that improve health and save lives.”[3]  NIH is made up of 27 Institutes and Centers, each with a specific research agenda, often focusing on particular diseases or body systems. NIH leadership plays an active role in shaping the agency’s research planning, activities, and outlook.[4]

According to NIH, more than 80 percent of its budget “goes to more than 300,000 research personnel at over 2,500 universities and research institutions. In addition, about 6,000 scientists work in NIH’s own Intramural Research laboratories, most of which are on the NIH main campus in Bethesda, Maryland. The main campus is also home to the NIH Clinical Center, the largest hospital in the world totally dedicated to clinical research.”[5]  Click here for an NIH primer on the clinical trials process.

Congress doubled funding for NIH between Fiscal Year 1998 and 2003, raising its budget from $13.6 billion to $27.1 billion. During that period, annual budget increases of about 14 to 15 percent were common.  However, increases through the regular appropriations process have been between about 1 to 3 percent annually since.  The growth rate of NIH’s budget has been at or below the rate of inflation, which for biomedical research in fiscal year 2015, is estimated to be 2.2 percent.[6]  In constant 2012 dollars, “NIH funding in Fiscal Year 2015 is 22 percent lower than the Fiscal Year 2003 level.”[7]

The Food and Drug Administration (FDA), also part of HHS, has regulatory authority over foods, drugs, cosmetics, biologics, medical devices, electronic products that emit radiation, livestock feeds, pet food, and tobacco products.[8]  Within the FDA, there is an Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.[9]

The Federal Food, Drug and Cosmetic Act (FFDCA) is the “central federal law regulating the safety of most foods, food additives, color additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products.”[10]  The FDA, in its mission to assure that the products it regulates are safe and truthfully labeled, enforces the Act “through a series of administrative mechanisms, such as pre-market reviews of certain products, examinations and investigations, and the dissemination of information to the public.”[11]  Click here for a Congressional Research Service (CRS) report on the FDA’s drug approval process and here for a CRS report on the Agency’s regulation of medical devices.

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[1] See Chairman Upton op-ed
[2] Id.
[3] http://nih.gov/about/
[4] Id.
[5] Id.
[6] See CRS Report—“H.R. 6: The 21st Century Cures Act,” June 11, 2015 at 3.
[7] Id.
[8] http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm
[9] http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm
[10] See CRS Report—“Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues,” June 19, 2014 at Summary.
[11] Id.

Cost

The Congressional Budget Office (CBO) previously estimated that implementing H.R. 6 would authorize the appropriation of $100.9 billion during the fiscal year 2016 to 2020 period, resulting in estimated outlays of about $97.9 billion during that time, assuming the appropriation of authorized amounts. CBO further estimated that changes in direct spending required by the bill will reduce the deficit by about $524 million through the fiscal year 2016 to 2025 period.

A CBO estimate is not currently available for the Rules Committee Print. However, the funding has been changed from mandatory to discretionary. In addition, the overall spending was lowered from $9.3 billion to $6.3 billion, and the bill includes cuts to the Affordable Care Act. Finally, the new discretionary spending in the funds are matched dollar for dollar in reductions in budget authority on a yearly basis.

Additional Information

For questions or further information please contact Jake Vreeburg with the House Republican Policy Committee by email or at 6-1828.