Public Policy Briefing
October 20, 2016
21st Century Cures -- Because Patients Can't Wait SM!
   
On July 10, 2015 -- more than one year ago -- the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. Earlier that year in May, the legislation was passed unanimously by the House Energy & Commerce Committee. The overwhelming passage of that legislation, as well as the unanimous vote out of Committee, was especially significant, given the divided nature of the House.
 
The bill received tremendous support because it was crafted as a bipartisan effort, focusing on efforts to streamline the Food and Drug Administration bureaucracy, invest in more medical research at the National Institutes of Health and incentivize more rapid development of cures -- important steps toward ensuring better healthcare and lower costs for all Americans.
 
In spite of that message of support, the Senate Health, Education, Labor & Pensions Committee decided to submit its own package of bills rather than consider the House legislation. On January 19, Senate Health Committee Chairman Lamar Alexander (R-Tenn.) released the Senate Health Committee's mark-up schedule for step by step consideration of biomedical innovation bills, and the Committee completed its work on marking up biomedical innovation bills on April 6.
 
On July 11, Senate Health Committee Chairman Lamar Alexander (R-Tenn.) noted that the Senate should finish its work on 21st Century Cures in September, saying  "Rarely do we have such an opportunity: it includes support for the President's Precision Medicine initiative and the Vice President's Cancer Moonshot. Speaker Ryan has said that 21st Century Cures is a major part of his health care agenda. Majority Leader McConnell says he wants to pass the bill this year."
Senate Must Act in Lame Duck Session  
 
Unfortunately, Senator Alexander's prediction proved overly optimistic. No action was taken in September, and with the Senate expected to adjourn shortly and not return until after the election, there is little likelihood that it will be considered before adjournment. All legislation dies if it is not passed before the Congressional session ends in January 2017, so the bill must pass in the lame duck session or be re-introduced in the 115th Congressional session, which will run from January 2017 to January 2019.  
 
Disagreement over funding of the Act, specifically the mandatory funding for research at the National Institutes of Health (NIH) is responsible for the delay. Democrats support increased funding that will make up for years of budget cuts, while Republicans say that a restructuring of the NIH budget is required before they support additional funding.
How Does the 21st Century Cures Act Benefit Patients?
 
The Cures Act is comprised of four major elements:
  1. Cutting red tape by modernizing clinical trials to expedite the development of new drugs and devices
  2. Focusing on personalized medicine by encouraging more collaboration among Patients, physicians, innovators, researchers, developers and regulators
  3. Investing in the future of science: The bill provides an additional $8.5 billion to the National Institutes of Health's innovation fund, as well as more resources for the Food and Drug Administration.
  4. Keeping funds directed to approving new drugs and medical devices by exempting future Food and Drug Administration user fees from sequestration, a procedure by which across-the-board spending cuts go into effect if Congress fails to agree on a deficit-reducing budget before a specified date.
Many of the House provisions have been passed separately by the Senate but there are significant differences between the two versions of the legislation. Several important provisions in the House-passed 21st Century Cures Act do not have companions in the package of Senate measures, including the NIH reauthorization, a streamlined data review program and provisions to utilize evidence from clinical experience in the new drug approval process.  
The Bottom Line: Patients Need Help Now!
 
Tremendous progress has been made in medical innovation and treatments in recent years, but there are still many unmet Patient needs. BioNJ gratefully acknowledges Congressmen Leonard Lance and Frank Pallone for their groundbreaking work on 21st Century Cures, and urges New Jersey Senators Menendez and Booker to support swift Senate HELP passage of legislation that will advance the provisions of 21st Century Cures.
 
On Friday, November 4, BioNJ's inaugural Patient Advocacy Summit will bring together Patients, Patient advocacy groups, industry and government for a day of education, engagement and empowerment. Registration is limited -- please contact Randi Bromberg at [email protected] to learn more.
 
For more information about BioNJ's Public Policy program, please contact Rebecca Perkins, BioNJ Vice President, Government Affairs, at [email protected].  
For more information about BioNJ, visit www.BioNJ.org.