Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for research, streamlined approvals for drugs and devices as well as funding to improve the Food and Drug Administration’s (FDA)  ability to hire top quality scientific talent by increasing pay and improving the hiring process.  The House of Representatives recently passed Cures by a similarly wide bipartisan margin of 392-26.  The Senate vote marks a milestone victory for Cures champions including outgoing Energy and Commerce Committee Chairman Fred Upton (R-MI), Representative Diana DeGette (D-CO) and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN).

Specifically, Cures provides:

  •  $4.8 billion for President Obama’s Precision Medicine Initiative
  • Funding for the Cancer “moonshot” initiative
  • $500 million to the FDA to get drugs and medical devices to patients more quickly
  • $1 billion in state grants for opioid abuse prevention
  • Reauthorization of  the pediatric rare disease priority review voucher program until 2020 with the possibility for an extension to 2022 if a drug is designated by October 1, 2020.
  • Updated FDA regulation of Class I and II medical devices as well as medical software
  • Improvement of medical information reporting through electronic record (EHR) interoperability and usability
  • Improvements (but no funding) for mental healthcare policy previously proposed by a number of lawmakers

A section-by-section breakdown of the version passed by the House of Representatives and adopted Senate is available here.   The only major change between the House and Senate versions came in a separate but related action,  where the Senate adopted a House resolution to rename the “moonshot” project the “Beau Biden Cancer Moonshot” in honor of Vice President Joseph Biden’s son.

With the inclusion of the opioid, cancer moonshot and mental health provisions, passage of Cures was all but assured. However, that didn’t assuage all opposition nor does it end the debate on the future of drug and device innovation.  Senators Elizabeth Warren (D-MA), Jeff Merkley (D-OR) and Bernie Sanders (I-VT), joined some consumer groups in opposition to the legislation believing that Cures does not do enough to control the rising cost of prescription drugs and that it increasing the pace of approval could weaken FDA’s ability to ensure safe drugs and devices.  In addition, some policymakers including House Energy and Commerce Committee ranking member Frank Pallone (D-NJ), expressed concern that Cures funding is subject to the appropriations process and therefore not guaranteed in the future.  Finally, Senator Mike Lee (R-UT) voted “no” because Cures did not include language that would allow generic pharmaceutical companies to obtain samples of products under the Risk Evaluation and Mitigation Strategies (REMS) program. Senator Lee an others, including Senator Chuck Grassley (R-IA) and Patrick Leahy (D-VT) had supported an amendment to Cures based on a legislative proposal that would improve the REMS process as a method to control drug prices.

While today’s Senate vote ends the three year journey for Cures, its implementation is yet to begin. Moreover, much remains to be seen how reauthorization the various user fee acts in 2017 will interact with Cures, namely on the topics of drug pricing and device innovation.  We will be actively monitoring Cures implementation, user fee legislation and other activity in this arena.

Posted by Vince Sampson