The shutdown claims its first biotech victim

The drug industry's biggest shutdown fear has come true: The FDA is almost broke, and that's delaying new approvals. Aimmune Therapeutics, which filed its peanut allergy treatment the day before the shutdown, got word last night that the FDA won't consider its application until funding is restored.

And it might not be the last company forced to change plans. As STAT’s Nicholas Florko and Ike Swetlitz report, the FDA has about five weeks of funds left in its drug-review account, money raised from collecting industry fees. The shutdown prevents the FDA from accepting any new money, which means a handful of weighty decisions — on drugs from Johnson & Johnson, Sanofi, and Novartis — could be indefinitely delayed if conditions persist.

And, in pharma, that’s bad for business.

“Folks are freaking out because who knows what’s going to happen,” said Kurt Karst, an attorney at Hyman, Phelps & McNamara. “Publicly traded companies, they’re going to start issuing press releases or investor statements that FDA may not act.”

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