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Michael Causey

FDA Compliance

FDA Reorganization Signals More Inspections for Drug, Device Firms

Moving target of enforcement priorities will affect midsize device makers

Published: Friday, October 7, 2011 - 11:25

Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it was scripted by the same team handling Steve Carell’s departure from The Office and the ushering in of the new James Spader era.

Unfortunately, in real life these things aren’t always so funny. The FDA has been mocked in many quarters for its failure to maintain a balance between protecting the public safety and encouraging innovation among device and drug companies.

The list of FDA reorganization moves made in just the past year would fill pages of old-fashioned newsletter space, but suffice it to say that the FDA has made a lot of changes and shows no signs of stopping.

Question: Should device and drug manufacturers care?
Short answer: Yes.

Question: Do the FDA changes mean more inspections and enforcement action for device and drug manufacturers?
Short answer: Yes.

We’ve spoke with several drug and device company compliance officers during the past few months, and without exception we’re told that dealings with the FDA have become more time-consuming and frequent. Not surprisingly, no one wanted to go on record for fear of further irritating an already irritating (to them) agency.

“I didn’t like the FDA’s approach five years ago, but now I miss those days,” a midsize device firm compliance officer recently told us, only half-jokingly.

Areta Kupchyk, a partner and former FDA-er now at Reed Smith LLP, notes that “where FDA puts their resources typically reflects their priorities and approach to enforcement. For example, FDA appears to be putting resources in enforcement areas and giving some of those divisions more independent authority from the chief counsel’s office to take action,” she tells us.

“FDA also wants to speed review times for 510(k) submissions, orphan drug designations, and therapeutic biologics (especially biosimilars). The new acting Chief Counsel, Liz Dickinson, has a strong background in generic drugs and biosimilars, and we are very likely to see more focus in this area,” Areta adds.

These FDA changes are mostly going to impact mid- and small-sized companies on the device side, Areta says. “Large pharmaceuticals already basically understand how compliance works and how to do it, but the midsize device companies in particular don’t have enough experience with quality systems and GMPs,” especially as FDA’s interests and demands seem to keep changing.

This article first appeared in the Oct. 4, 2011, edition of the AssurXblog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.