House Votes to Expand FDA Power to Tackle Drug Shortages, Reauthorizes Pharma Industry Fees

House Votes to Expand FDA Power to Tackle Drug Shortages, Reauthorizes Pharma Industry Fees

 In Government Relations

In a rare instance of bipartisan cooperation between lawmakers on the Hill, the U.S. House of Representatives voted 387-5 on Wednesday in support of legislation that – if passed into law – would give the Food and Drug Administration (FDA) increased powers to tackle critical drug shortages, speed up medical device review and reauthorizes pharmaceutical industry user fees, which will require drug companies to pay the FDA nearly $6 billion over the next five years to help fund its review process.

Although branded drugmakers have been paying these fees since 1992, this bill marks the first time generic drugmakers and biosimilar manufacturers will be required to do so as well.

A similar version of the bill received near unanimous approval in a Senate vote last week. Both the House and Senate versions give the FDA power to force drug companies to report any therapy supply disruptions, so that it can work with other manufacturers to increase their production to ensure patients’ needs are met.

The Senate bill also included a plan to implement a national medication tracking system that would seek to curb counterfeit and stolen drug trafficking. As Senate and House members work to iron out a final version of the bill, it remains to be seen if this component will stay on the table. Although the FDA has urged passage of a plan that would track the distribution of individual vials of medicine, many distributors and pharmaceutical industry players say this plan would be too expensive to carry out.

Other discrepancies between the two versions of the bill that will need to be addressed include accelerated approvals for treatments for life-threatening diseases, which would lower standards of evidence for these drugs during the review process, as well as which antibiotics could qualify for incentives.

House leaders stated that they plan to work with their colleagues in the Senate to address the differences between their two versions and agree on a final bill by July 4.

With its expected passage this summer, this bill will almost certainly have widespread implications not only for the FDA, but for the pharmaceutical industry (who must pay more and report shortages earlier) and key patient communities who have been impacted by drug shortages that have made it difficult to get critical therapies. By requiring companies to report looming shortages farther in advance, the hope is the FDA can more effectively work to prevent interruptions to vital supply chains on which patients depend.