FDA Reform Act passes House vote

The U.S. House of Representatives voted this week in favor of the Food and Drug Administration (FDA) Reform Act, which sets forth several policy reforms pertaining to drugs and medical devices.

Approved by a 387-5 House vote, the bill would increase the so-called user fees drug and medical device companies pay to the FDA and should expedite the review process for these devices and improve transparency of their clearance process. Lawmakers are expected to have a final draft of the legislation by early July.

The bill – which some observers call a watered-down version of last week’s Senate-approved legislation – is projected to reduce the federal deficit by an estimated $370 million over the next decade according to the Congressional Budget Office. Eyeing such savings, lawmakers from both sides of the aisle have worked through – if only for a brief moment – ideological differences that have often stymied the legislative progress in recent years.

“Our bipartisan reform package is the culmination of more than a year of work and negotiations between House Democrats and Republicans,” Rep. Fred Upton (R-MI) wrote this month in the Holland (Mich.) Sentinel.

"The FDA Reform Act contains important metrics that will hold the FDA accountable for its performance, will help provide new therapies to our nation’s children, significantly improve scientific exchange at FDA’s advisory committees, and ensure transparency and public input in the development of FDA’s guidance documents,” Upton added in an Energy and Commerce Committee press release earlier this month.

The bill includes the following provisions:

  • Reauthorizes part of the Pediatric Medical Device Safety and Improvement Act of 2007, which will provide grants to non-profits groups promoting pediatric medical device development.
  • Approves a five-year price tag of an estimated $6.4 billion in user fees, with $609 million of the funding coming from medical device user fees companies will pay to the FDA. The fees will be used to improve and extradite the medical device review process, so they can be available to patients sooner.
  • Expedites the approval process of certain prescription drugs by easing on some restrictions. 
  • Reauthorizes the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), both of which aim to improve safety and efficacy of prescription drug treatments for children. 
  • Addresses national prescription drug shortages by adjusting requirements when seen fit and would involve providing the public with a list of prescription drugs in short supply.