Legal Loophole Might Keep Drug Approvals Coming

Two former FDA lawyers say that since some drugs in the pipeline can save lives, they could be approved despite the government shutdown.

The Antideficiency Act prohibits federal employees from working during a shutdown, “except for emergencies involving the safety of human life or the protection of property.” Stat this morning reports on comments given in an industry webinar by two lawyers who once worked for the FDA. They think that that law might allow the approval of medications even after the money runs out.

That money comes from fees drug companies already paid to have their products approved. But it runs out February 17, or maybe February 28, depending on how the agency handles the situation.

Then what?

Rebecca Wood, was the FDA’s chief counsel until July and is now a partner at Sidley Austin. “At what point would someone be able to craft an argument that they are trying to fill a therapeutic gap for a patient population that can’t wait?” she asked. “That may be where you see a whole new round of legal and policy interpretations we just haven’t seen before.”

Howard Sklamberg, former deputy commissioner for global regulatory operations and policy at the FDA, and currently a partner at Akin Gump, said that “you can’t have the drug and medical device approval system stop for months and months without it having an effect on patients.”

Stat reports that “Sklamberg and Wood made these comments in the context of products that the FDA would review under the ‘breakthrough’ or ‘accelerated approval’ designations, which means that the drugs might be much better than what’s currently on the market.”