FDA Reorganization Signals More Inspections for Drug, Device Firms
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.
Under pressure from all sides, the beleaguered FDA keeps announcing new reorganization initiatives, name changes and more. 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.
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 in the past few months, and without exception we’re told that dealings with the FDA have become more time-consuming and frequent. Not surprisingly, none wanted to go on the 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 mid-size 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 mid-size 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.