Pharma, Policy

Quality over compliance? FDA’s shaking it up. #CEDLSC15

Change is afoot over at the Food and Drug Administration. Richard Moscicki, deputy center director of science […]

Change is afoot over at the Food and Drug Administration. Richard Moscicki, deputy center director of science operations for the FDA’s Center for Drug Evaluation and Research, outlined some of the incremental steps at this week’s CED Life Sciences conference in Raleigh:

Finally looks like there’ll be some movement on the regulatory end for biologics approval: Moscicki said the FDA has 52 biosimilar programs under review, which are being modeled on 15 innovator drugs.

“In the past, particularly in biologics, it’s been true that our approach to quality has in fact inhibited innovation,” Moscicki said. “We want to change that, and make sure we encourage innovation in manufacturing.”

The basic idea here, he said, is to emphasize quality over compliance – so that better drugs will disseminate on the market without having to worry too deeply about stumbling in the regulatory process.

There’s been a greater shift to engage patients to the drug development process – so FDA is now working with patient advocacy organizations. It’s piloting patient-reported outcome programs and drafting guidances.

“In the entrepreneurial community, rare diseases are a good starting point,” Moscicki said. “So a big area we’ll go into is breakthrough designations.”

Breakthrough designation has indeed become very popular – there’s an “all-hands on deck approach” at the FDA to help push these applications through. Of 200 requests, FDA has thus far granted more than 60, Moscicki said. Here’s his slide:

 

Also, the GAIN Act for antibacterial drug development is gaining steam – last year, 30 programs qualified and there were six drug approvals.

The biggest FDA shift Moscicki predicts will be, of course, the change of a commissioner as Margaret Hamburg steps down. Other changes will include a reevaluation of FDA’s rules on advertising, promotions and labeling – thanks to a recent debate around the First Amendment that could impact off-label usage of drugs. The Hill is actively working on enacting the 21st Century Cures initiative, and PDUFA is in the midst updates as well.

“There will be change,” Moscicki said.

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