As the government shutdown drags into its second month, healthcare groups are worried that the FDA will run out of money, jeopardizing the safety of U.S. consumers. But two former FDA lawyers say that the agency could continue to work if it argues that reviewing certain drugs is essential to protecting people's lives, STAT reports.
Under the Antideficiency Act of 1982, federal employees can't work during a shutdown "except for emergencies involving the safety of human life or the protection of property."
The FDA is using this exception to keep up with some of its oversight duties, such as inspecting manufacturing facilities and screening imports.
But drug and device reviews are being treated differently. While the agency is still reviewing applications that were submitted before the shutdown, it is unable to accept new applications. Most drug reviews are funded through fees paid by companies seeking approval and other user fees, and this fund is quickly running out. Politico reported the money will likely be gone by mid- to late February.
"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?" asked Rebecca Wood, the FDA's chief counsel until last July. "That may be where you see a whole new round of legal and policy interpretations we just haven’t seen before."
The two lawyers said that the agency may push the argument in the context of drugs that are seeking review under the breakthrough or accelerated approval designations, which indicates that the drug may demonstrate substantial improvement over other clinically available drugs.
"You can’t have the drug and medical device approval system stop for months and months without it having an effect on patients," said Howard Sklamberg, former FDA deputy commissioner for global regulatory operations and policy, told STAT.
When STAT asked the FDA about this potential legal argument, a spokesperson said there were no details to share.
Read the full report here.