Generic user fees gain traction with Hamburg's backing

It looks as if user fees really are in the offing for generic drugs. After generics makers said last week that they're supporting the idea as a way to speed approvals of their products, FDA Commissioner Margaret Hamburg backed it, too. Revamping the current approvals process is "critical," she said, because agency funding won't provide the resources to clear the backlog of apps.

"Uncertainty and delays are costly to consumers, costly to industry and hurtful to the public's health," Hamburg said at the Generic Pharmaceutical Association's annual meeting (as quoted by the Wall Street Journal). "Without generic user fees, we simply cannot achieve for the public what we otherwise could."

The FDA plans to sit down with generics industry officials later this month to discuss user fees. Hamburg said the agency is also ready to start talking about user fees for approval of biosimilar drugs, the knock-off versions of biologics enabled by last year's healthcare reform bill. She also agreed with generics makers about the need to step up inspections of their plants, which need FDA clearance before products made there can win approval.

Not everyone loves the user-fees idea, however. As the WSJ notes, critics have raised questions about the idea of the FDA receiving funding from the very companies it's regulating.

- read the WSJ piece

Suggested Articles

Sun Pharma has recalled one lot of its generic metformin after finding high levels of the probable carcinogen NDMA in tested lots.

Six months after WHO declared a pandemic, the list of drugs proven to work against the virus remains short. Now, Fujifilm has added its drug Avigan.

ICER said that Vertex's triplet CF therapy Trikafta would only be cost effective if the price were dropped from $311,000 to no more than $85,500.