“What we are trying to do is to keep the review process continuing because of important drugs in the pipeline,” he said.
Yet the cost-saving measures will buy just weeks, not months, of extended life for the FDA’s drug-review process, Gottlieb added.
The FDA’s new plans are a sign of the burgeoning impacts of the impasse, some visible and others invisible to the public.
Prescription drug reviews and some related activities are funded by user fees paid by pharmaceutical companies. The 2018 fees are expected to run out about Feb. 8, Gottlieb said. The FDA is not allowed to collect the 2019 fees during the shutdown. But it can shift some of the remaining 2018 fees from ancillary activities to the reviews themselves.
Drugs to treat epilepsy, triple-negative breast cancer and spinal muscular atrophy are just a few of the medications slated for review over the next several months. FDA supporters are worried the partial shutdown will disrupt the momentum of an agency that had a record year in 2018, with 59 new-drug approvals.
“A core part of the FDA is advancing innovations that will benefit patient care,” Gottlieb said. “We are trying to make prudent decisions to keep that process going.”
Ellen Sigal, chair of Friends of Cancer Research, said an extended delay in drug approvals could leave patients “desperate for the next breakthrough without hope.”
Policy initiatives such as modernizing the FDA’s drug-review office will be put on hold, Gottlieb said. So will work on some guidance documents, which spell out the agency’s thinking on various matters. Contracts with outside businesses will be deferred. And the agency will stop holding advisory committee meetings.
The FDA is funded by both congressional appropriations and user fees paid by various industries. Many FDA staff members whose activities are financed by appropriations have been furloughed, though some, such as food inspectors, have been brought back without pay because their work involves a critical public health issue. Drug reviewers are not permitted to work unpaid like the food inspectors. That’s because a lack of drug reviews is not considered a threat to human safety, officials said.
The FDA is not permitted to accept 2019 drug-company applications during the shutdown, so the agency expects a rush of those as soon as things are back to normal. That could create backlogs and result in a lower total of drug approvals for the entire year.
Joshua M. Sharfstein, who was deputy FDA commissioner during the Obama administration and now is vice dean at Johns Hopkins University, warned that consumers would be hurt if the drug-review division were to run out of money.
“With the pace of medical innovation today, having the FDA out of the action even for a month is not an insignificant problem,” he said.
Ladd Wiley, executive director of the Alliance for a Stronger FDA, an industry and consumer advocacy group, agreed that “there’s no easy way for the FDA to quickly make up lost time.”
Not everyone is worried. “I just have a hard time believing that this shutdown is going to turn into Armageddon and that drugs aren’t going to get approved and there’s going to be utter chaos,” said Brad Loncar, chief executive of Loncar Investments, which focuses on biotech companies.
The possibility of an extended shutdown has many drug analysts scratching their heads about the potential impact.
“I’ve been covering this area for 11 years and I have never seen anything like this,” said Vamil Divan, a senior research analyst at Credit Suisse. He said he thought big pharmaceutical companies could easily weather the increased uncertainty in the process but was worried about the impact on small companies with one or two products.
Still, he didn’t think consumers would be affected much if any particular drug approval were to be delayed by a month or two.
“Very few patients get new drugs in the first month or two, and some are already getting them in clinical trials,” he said.
Kim Monk, managing director of Capital Alpha Partners, said the shutdown was a “growing problem” for the FDA. If the agency runs out of money for drug reviews, she said, “it’s not a cliff, but it could create a backlog.”
That would be a shame, she said, since the FDA has worked hard to reduce its backlog of generic drug applications.