Product Failure Is Not Process Failure


The FDA must never be flexible. Flexibility is for losers. Flexibility makes the regulatory process look like a wet noodle, lacking rhyme, reason, and predictability. Flexibility doesn’t instill confidence in an increasingly high-risk developmental environment. What the FDA must be is “nimble.” It’s a distinction with a difference.

Regulatory Nimbleness understands and respects the need for process. Undefined and anecdotal “flexibility” can easily lead to regulatory pandemonium. Nimbleness must enhance progress through process, not result in entropy. New approaches require well-considered rules because, as Victor Hugo reminds us, “Where the disposal of time is surrendered merely to the chance of incidence, chaos will soon reign.” Flexibility bends rules. Nimbleness reads between the lines. Nimbleness looks to the spirit of the FDA’s mission. Experts are nimble.

Witness the agency’s recent experience with Relyvrio (for amyotrophic lateral sclerosis). Approved after an almost unheard of second advisory committee vote and over the objections of many on the divisional review team, the product flamed out (there is no subtler way to put it) in a comprehensive Phase IV study. Not surprisingly (but still disappointingly), the ossified standard bearers of the regulatory status quo took the opportunity to claim the failure of the product was proof positive that the FDA’s progressive approach to 21st century regulatory science was a failed experiment. They’re 100% wrong. Product failure is not process failure, and those who chose to link the two only show the paucity of their understanding of how drug regulation works.

As Steve Usdin argues in his recent commentary, ALS disappointment should not close the door on patients, “New regulatory approaches are sorely needed for rare disease drugs. They need to reflect scientific consensus, and to be applied via a well-reasoned and consistent decision-making framework. One-off moves make the drug development process unpredictable for both patients and companies and are all too likely to backfire.”


 
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