Seeking middle ground for the FDA

Thinking out loud here. There has to be some message about pharma industry regulation when the first update to a core guidance document appears 24 years after the original. That's the case with the FDA's process validation guidance. It was first published in 1987--year of the Black Monday stock market crash, the debut of the Simpsons on The Tracey Ullman Show, and the introduction of Prozac in the U.S.

Two possibilities for what that message might be: Drugmaking processes change very, very slowly, or regulators move very, very slowly.

If the former, one reason might be truth in the old saw about the pharma industry being a slow technology adopter. That could be driven by drugmakers spending so much money on discovery and development that they have nothing left over to invest in process improvement.

After all, reports of drug candidates advancing from one phase of clinical testing to the next, and about the rise and fall of sponsor companies following FDA review of trial results, appear far more frequently than news about such process-focused initiatives as the Novartis-MIT Center for Continuous Manufacturing effort, now in year four.

You may have missed it, but the center's associate director, James Evans, spoke recently about integrated continuous pharma manufacturing and how close we're coming to achieving it. That's a long ways from the discussion of batch sampling requirements for validation in the new FDA guidance.

Another reason for the slow-process-change theory might be that drugmaking by virtue of the intricacies of physical, chemical and biological properties is so complex that manufacturing resists all attempts at improvement. This amounts to a "we're not smart enough" principle. If we believe it, then we deserve what we get.

But if the latter message possibility is correct--that regulators move very, very slowly--one reason might be discontinuity in the definition of "regulation" by our two political parties. The unscheduled shifts from strict, authoritarian regulation to a loose, stay-out-of-the-headlines style defy attempts at long-term planning that would create regulatory consistency and steady improvement, the very aims of the guidance.

Forbes magazine editor Steve Forbes excoriates the FDA in a recent editorial, blaming a government regulation failure---rather than a market failure, as Congressman Henry Waxman does--for the lack of new antibiotics. Although his chief complaint is with the agency's "increasingly horrific bureaucratic roadblocks" to drug development, his arguments extend to some extent to manufacturing regulation.

Forbes says that if our drug regulation system is left unchanged, we'll be facing a "...bacterial apocalypse. The horrors that we thought were banished 70 years ago are coming back."

I'm not willing to buy into his moving-backwards scenario. But perhaps there's some middle ground that our two political parties might explore between Forbes' doomsday vision and quarter-century guidance updates. George Miller

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