Exclusive: McConnell expects bipartisan support for bill reauthorizing FDA user fees

WASHINGTON U.S. Senate Republican Leader Mitch McConnell told Reuters on Wednesday he expects bipartisan support for approval of a bill authorizing taxpayer and industry funding for the U.S. Food and Drug Administration.

The bill to reauthorize the Prescription Drug User Fee Act would let the FDA continue to collect hundreds of millions of dollars from drugmakers and medical device companies to partially cover the cost of reviewing new products, with U.S. taxpayers funding the remainder.

“It’s an extremely important bill that I think we’ll be able to move on a bipartisan basis,” McConnell said in an interview. [L1N1IQ1CH]

The FDA has been charging companies to review their products since 1992. On Tuesday, President Donald Trump proposed in his 2018 budget that the industry pay the full cost of drug and medical device reviews.

The industry at present pays about 60 percent. That proposal is unlikely to be approved in this cycle.

Reauthorization of the user fee bill is typically negotiated between the FDA and industry over a period of several years.

Earlier this month, the bill was approved by a Senate panel by a 21-2 vote. It must be renegotiated every five years.

The FDA reviews drugs for approval or rejection for many companies, including major ones such as Pfizer Inc, Merck & Co Inc and Johnson and Johnson. Pharmaceutical companies based overseas, including Roche Holding AG and Novartis AG, also pay these fees for U.S.-approved drugs.

Senate Majority Leader Mitch McConnell (R-KY) speaks to Reuters during an interview in Washington, U.S., May 24, 2017. REUTERS/Joshua Roberts