August 17, 2016

Has “Cures” Time Finally Come?

Mitch Vakerics

After more than a year of press releases by the Energy & Commerce Committee promoting 21st Century Cures on a weekly, slow-drip basis, has the time finally come for Cures to become law?  While countless self-imposed deadlines have come and gone, this one could be real. 

The September deadline is different from the many that have come and gone to no avail.  The primary difference is Speaker Ryan’s involvement.  The Speaker recently said “21st Century Cures is a major part of my health care agenda.”  Couple that with Majority Leader Mitch McConnell saying he wants to pass the bill this year, and suddenly passage seems realistic.

Chairman Lamar Alexander (R-TN) has finally caught up to Chairman Fred Upton (R-MI) on the urgency of passing the bill.  Further, it should help that Cures includes support for the President’s Precision Medicine initiative and the Vice President’s Cancer Moonshot. 

While September could easily become November or December, many believe some form of Cures will head to the President before 2017.

The 21st Century Cures bill is the brainchild and potential legacy item for Chairman Upton.  The landmark legislation would accelerate the discovery, development and delivery of new drugs and medical devices by reforming the FDA.  H.R. 6 passed the House more than a year ago with overwhelming bipartisan support (344-77).  The Senate HELP committee approved a companion measure this spring in a legislative package of nineteen bills.

Passing H.R. 6 by a huge bipartisan majority was a great victory.  But, acting too fast, and having a blockbuster bill languish in the Senate for over a year leads to problems.  Most importantly, your pay-fors get used for other purposes.  Covering an $8 Billion price tag requires a lot of them.  As time passed, more and more Cures pay-fors were grabbed by legislation moving on more pressing timelines.  Before he knew it, Chairman Upton was left with great policy and nothing to pay for it.

Many in this town would like to see Fred Upton get his crown jewel as he hands over the gavel of Energy and Commerce.  A key factor will be keeping secret all the pay-fors his committee has scrapped together over the past six months.  Chairman Upton also faces a short calendar when Congress returns in September; only thirty-three legislative days before the year is done.  Moreover, because the bill is not a “must pass”, Cures could get undermined by more pressing items like funding the government and containing the Zika outbreak.  A frenzied partisan election year is not helpful either.  Finally, the mandatory spending included for NIH in the House version, to the tune of $8.75 billion, has given some conservatives pause as the money would not be subject to annual appropriations.  However, many Democratic senators on the HELP committee have made clear that no FDA innovation bill will get their support without mandatory funding for NIH.

Chairman Upton has always been a unifier and likeable guy that works with all to get the job done.  Let’s hope he’s got some good will left in the tank before the year ends.


Mitchell Vakerics

Mitchell has been delivering trusted counsel across a diverse practice of legislative, policy and political issues for more than a decade. During his long-standing tenure both in Congress and throughout the political and policy sphere of Washington, he has tackled some of the largest healthcare, energy and regulatory issues presented before the federal government. He has a massive range of relationships and strategic congressional partnerships has paid dividends for consecutive congressional sessions. Mitch is a member of Prime Policy Group’s healthcare practice.