The FDA cannot collect user fees during the government shutdown, which are crucial for funding new drug reviews.
18 Jan, 2019FORTUNE.COM
In the longest government shutdown in U.S. history, the Food and Drug Administration (FDA) has trimmed food inspections, furloughed workers, and cut back on lower-priority tasks wherever possible to reduce costs.
More crucially, it has also stopped collecting user fees paid by pharmaceutical companies for new drug and medical device reviews.
This means that the FDA is stuck shifting around leftover fees from 2018 in a desperate attempt to continue the essential drugs tests.
FDA commissioner Scott Gottlieb told the Washington Post that he will enact additional furloughs and cut back further on discretionary activities in an effort to keep the drug and device approval pipeline going. Last year was a record for the FDA, with 59 approvals.
"A core part of the FDA is advancing innovations that will benefit patient care,” said Gottlieb. “We are trying to make prudent decisions to keep that process going,"
Despite this, one biotech company has reported to investors that review of Aimmune, an immunotherapy for peanut allergies, is delayed. Blood- and allergy-related treatments are not user-fee funded, so the FDA treats them separately.
In an odd twist, drug reviewers are not allowed to work unpaid, as some food inspectors are, because the job is not considered crucial to human safety. So if the FDA wants to keep them at the office, it must find the funds to pay them.
Even by shifting the funds, Gottlieb estimates he can only gain a few weeks, but not months, for continued drug approvals (he told the Post he expected the 2018 fees to run out about Feb. 8). For devices, which again operate under different rules, the agency has about three months’ worth of review funding lined up.
Delays and the associated uncertainty would hit small drugmakers worst as larger firms have the budgets to ride out the storm. In the meantime, the FDA is warning people in rhyme not to eat cookie dough.