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:

Next Article in News

Email Newsletters

More in News

FDA kind of OKs Lilly/BI's Lantus look-alike

FDA kind of OKs Lilly/BI's Lantus look-alike

Sanofi's patent lawsuit triggered the tentative approval of the Lilly-BI Lantus competitor.

GSK relaunches COPD.com

GSK relaunches COPD.com

The refresh launched soon after the company encouraged investors to take a long view of GSK as the firm posted weak respiratory numbers.

Six things for pharma marketers to know: Tuesday, August 19

Six things for pharma marketers to know: Tuesday, ...

Lilly/BI receives tentative approval for insulin biosimilar; Ebola death rate hits new high; LaMattina sounds off on Pfizer's oncology efforts; art therapy becoming the norm in hospitals.