House approves FDA bill, medical devices to see new regs

Lawmakers recently found themselves in the unfamiliar territory of bipartisanship when the House of Representatives voted overwhelmingly in favor of the Food and Drug Administration Reform Act. 

Approved by a 387-5 vote, the bill sets forth several policy reforms pertaining to drugs and medical devices. The legislation will increase the so-called user fees that are paid by drug and medical device companies 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 recent 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 overlooked 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-Mich.) 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:

• Reauthorizes part of the Pediatric Medical Device Safety and Improvement Act of 2007, which will provide grants to non-profit 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 pot coming from medical device user fees that companies will pay to the FDA. The fees will be used to improve and extradite the medical device review process so they can be made available to patients sooner. 

• Expedites the approval process of certain prescription drugs by easing some restrictions.  

• Reauthorizes the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), both 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 which would involve providing the public with a list of prescription drugs in short supply. 

Erin McCann

Associate Editor for Healthcare IT News

Follow Erin on Twitter @EMcCannHITN