Fees don’t threaten FDA independence

Share this article:
FDA commissioner Andrew von Eschenbach told a public meeting on reauthorizing the Prescription Drug User Fee Act in February that while his agency needs more user fees, this doesn’t mean it has lost its independence from the companies who are paying those fees.

“There should be no confusion about who FDA serves,” he said. “It’s important to get drugs rapidly to market, but rapid does not mean reckless…We’re not focused on where our resources come from—only on what they allow us to do.”

Von Eschenbach indicated that administrative changes were under way to place the agency’s drug review program on a sound financial footing; enhance the process for premarket review of human drug applications; and modernize and transform the postmarket safety system.

In addition, the FDA presented a related proposal (separate from PDUFA) that would assess fees for advisory reviews of DTC television advertisements.

FDA associate director for policy Jane Axelrad said only firms that voluntarily submit DTC TV ads for advisory review will pay the fees, projected to be $6.25 million annually, adjusted for inflation and workload.

She explained there would be a one-time participation fee in the first year of the program, based on anticipated submissions, and annual pre-payment for advisory reviews thereafter. The cost for each submission will be $6.25 million divided by the number of submissions that are identified by sponsors.

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Channel

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...