21st Century Cures Act: Success in a Lame Duck Session

As the President signs the 21st Century Cures Act into law today – we’re reminded that every once in a while, Congress can be productive during a Lame Duck session.

While heavily debated, and stuck for months, the bill ultimately passed with overwhelming support in both the Senate and the House – 94 to 5 and 392 to 26 respectively.

This bi-partisan legislation makes several reforms to the FDA, authorizes increased funding for the National Institutes of Health, addresses the mental health crisis in our country, and improves electronic health records.

In addition to these improvements, the bill also authorizes funding to fight the opioid addiction crisis (an issue FTP has worked on with the American Medical Association and others) and White House priorities including: personalized medicine, the BRAIN initiative, and most famously, Vice President Biden’s “Cancer Moonshot.

While the passage of this bill is a victory for patients and needed innovation in the drug development, review, and approval process, it certainly does not mean the healthcare debate is over.

So what’s next for healthcare policy?

Most significantly, with the election of President-elect Donald Trump and continued Republican control of both the House and Senate, Republicans and now poised to fulfill their promise to repeal the Affordable Care Act (ObamaCare). Congressional Republicans’ stated goal is to have a repeal bill passed and on the President’s desk on the day of President-elect Trump’s inauguration (January 20, 2017).

There are many questions about a repeal bill that have yet to be answered. What will it look like? Will it require a budget reconciliation, or move through regular order? Will it retain some of the more popular provisions of the original bill? Will everything be repealed immediately upon signing of the bill into law? Or will there be a phasing in of the repeal? The answers to these questions will begin to manifest themselves in the coming weeks.

Another significant piece of healthcare legislation that is a must-pass item is the reauthorization of the numerous user fee acts (Prescription Drug, Medical Device, Generic Drug, Biosimilars, and Animal Drug – collectively referred to as the UFAs), all of which expire on October 1st, 2017.

Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the review activities of the FDA have been funded in part through these fees. In the original 1992 legislation, these fees applied exclusively to prescription drugs. However, in subsequent  reauthorizations of PDUFA, Congress expanded these user fees to other industries that rely on timely review by the FDA – industries whose products require an effective review process in order to enter the market.

By supplementing federal appropriations, these fees have allowed for the FDA to greatly increase its staff capacity and update technologies, significantly reducing review times – in short, this funding plays a huge role in the efficacy of the agency.

While the timely reauthorization of these user fees is important – to prevent any type of logjam at FDA in getting these products reviewed, approved, and out to patients who are desperately awaiting them –  the UFA reauthorizations can become magnets for legislators who see these reauthorizations as the appropriate place to seek policy changes outside the scope of the underlying legislation. A common occurrence when Congress considers must-pass legislation.

Managing this “Christmas Tree” effect will be the challenge of the Senate HELP and House Energy and Commerce leaders as they shepherd these bills through their respective Committee markups and floor considerations.

Mr. White is a Senior Vice President at Forbes Tate Partners