FDA, Politics

Experts fret over a new hiring freeze at the FDA. Will the fallout be toxic to drug reviews?

With hundreds of open positions and a slate of new initiatives to execute on at the FDA, President Donald Trump picked a particularly inconvenient time to declare a hiring freeze for the federal government.

No one really knows how this is going to play out, but the speculation is rampant that the FDA will be forced to cut loose from its review timelines, which could have a big impact on a wide range of biopharma companies.

Bob Pollock, who blogs on FDA guidance documents for Lachman Consultants, notes that the agency is expected to get a record 1600 ANDAs this year. Trump’s freeze could slow reviews on generics to a glacial pace, which in turn would interfere with the introduction of new discounted drugs that could go a long way to removing pressure on new drug prices.

Writes Pollock:

(W)hile hiring freezes and restrictions of new regulations are not uncommon during a change of administration, with the new President’s pledge to reduce government and cut regulations by 75%, we could be in for a long, unpleasant haul.

The FDA was charged under the 21st Century Cures Act to speed up reviews of antibiotics and biologics, which includes a new designation for regenerative advanced therapies (yes, that’s RAT) tapped for accelerated handling. Now the hiring freeze creates uncertainties on how that will play out, at a time that the industry has been promised faster approvals.

CDER had 700 openings late last year. And its bureaucratic approach to hiring slowly left agency officials complaining that it was already hard to compete with the private sector. That’s likely to get considerably worse.

“We move rather slowly — like a snail might be a better analogy,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, according to a Washington Post article last fall. “A young person with a family can’t wait four months for us to get through some of the federal hiring process. So if they have something else that’s more . . . expedient, they will take that.”

There is a loophole here. Trump can exempt FDA jobs under an exemption for public safety workers. But there’s no guarantee he will.

The only guarantee Trump can offer now is a rising level of uncertainty over the administration’s plans for the FDA. And that could take months to clarify during a particularly critical year for the biopharma industry.

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