Memorandum

Senate passes 21st Century Cures Act in decisive 94-5 vote – December 7, 2016

Executive Highlights

  • The United States Senate voted 94-5 to pass the 21st Century Cures Act earlier this afternoon. President Obama has previously announced his intention to sign the bill as soon as it reaches his desk, which means the Act could become law by year-end.
  • While the Act has been significantly edited since it first passed the House in July 2015 (but was voted down by the Senate), we see the provisions for (i) >$6 billion in funding for key research initiatives (including $4.8 billion to the NIH), (ii) a structured framework for patient experience data to be considered in the regulatory process, and (iii) a faster process of approving drugs and medical devices so they more swiftly reach patients in-need as exciting steps forward in the healthcare landscape.

In another decisive victory for the 21st Century Cures Act, the bill passed the Senate this afternoon by a wide margin of 94-5, after passing the House of Representatives with a 392-26 vote last week. The Act is a sweeping bill with two overarching goals: (i) to revamp the process for drug and medical device approvals; and (ii) to provide more funding for medical research. It will now now move on to the desk of President Obama, who has already expressed strong support. In fact, he shared his intention to sign the bill into law as soon as it reaches his desk during a recent weekly address (see also the Obama administration’s official statement emphasizing that the advances to be made by the Act far outweigh the concerns). If all continues smoothly, we hope the 21st Century Cures Act – with its massive implications for chronic conditions like diabetes – will be enacted into law by end of year.

We’ve been watching the progress of this bill for quite some time, and notably, the version that’s now been approved by both branches of Congress is markedly different from the original 21st Century Cures Act that passed the House in July 2015 (but was voted down by the Senate). Where the earlier iteration guaranteed $10 million in mandatory funding to the NIH, the current bill allocates $4.8 billion to the NIH (of >$6 billion in total for key research initiatives) over 10 years with the stipulation that these funds must be reauthorized by a congressional vote every year. The current bill does not guarantee funding for all 10 years – this point is troubling for some, especially in light of the uncertainty surrounding President-elect Trump’s plans for healthcare. Revisions made to the Act since July 2015 have been focused on garnering support from the Senate, so it’s fitting that the bill has now passed with strong bipartisan support (with endorsements from Republican Speaker of the House Paul Ryan and Democratic Minority House Leader Nancy Pelosi alike). While we would have been delighted to see the 21st Century Cures Act become law as it stood last summer, we remain positive in the potential for the current bill to stimulate innovative medical research, shorten the time gap for new therapies to reach real-world patients, and create a structured framework for patient experience data to be considered in the regulatory review process for drugs and devices. These are three areas that deeply affect people with diabetes, and we so hope that this highly-anticipated bill is carried through in the years ahead.

  • See our coverage of the 21st Century Cures Act passing the House last week for more analysis on the bill’s provisions, strong points, controversies, and criticisms.

-- by Payal Marathe, Helen Gao, and Kelly Close