If the shutdown drags on at FDA, it will put anticipated new treatments in jeopardy ByNicholas Florko@NicholasFlorkoandIke Swetlitz@ikeswetlitz
January 14, 2019
FDA Commissioner Scott Gottlieb Michael Reynolds/EPA
WASHINGTON — The government shutdown could soon jeopardize highly anticipated new drugs from Janssen, Sanofi and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies, according to a STAT analysis of upcoming regulatory decision dates.
President Trump has warned that the shutdown — already the longest in history — could stretch on for “months or even years.” And though the Food and Drug Administration can retain more than half of its workforce thanks to application fees paid by drug and device makers, Commissioner Scott Gottlieb has cautioned the agency only has about three more weeks’ worth of funding to draw down. The agency can’t accept any new fees during the shutdown.
So far, the agency’s sizable coffer of leftover cash has ensured that the FDA can continue to review any drug applications submitted before the shutdown began. For example, FDA held a scheduled expert panel last week to discuss approval of Takeda Pharmaceuticals’ gout drug Uloric.
More than ten drug makers, however, are expecting the FDA to make a decision on their products in March — after Gottlieb anticipates the agency will run out of funds. And any delay in decisions expected in March could have ripple effects that delay other highly-anticipated products, like, for example, GlaxoSmithKline’s HIV treatment Tivicay/Epivir.
That uncertainty has Washington — and the drug industry — clamoring for answers. FDA has already taken more time than it said it would to release a plan for dealing with drug review during the shutdown, and on Friday, 34 Democratic senators sent a letter to Gottlieb demanding specifics about what happens when funding runs out. Gottlieb said in early January he would release more information about remaining funds before Jan. 12; that analysis is now set to come “this week,” he relayed Saturday.
Even two FDA employees, both of whom are still working on drug applications during the shutdown, told STAT the agency has not yet communicated its plan to them. Drug companies awaiting scheduled approvals said similar.
“Every bit of predictability in process —the heart of [the FDA user fee program] — melts away in the face of this,” Steven Grossman, deputy executive director of the Alliance for A Stronger FDA told STAT. “If you don’t have a lot of cash, this could put you out of business.”
The roughly $2.5 billion user fee program has steadily grown over the past two decades to encompass medical devices and even tobacco products. Companies who submit drugs to FDA pay between $1.2 and 2.5 million in application fees, or user fees. (Other products pay similar — albeit typically smaller — fees.) In return, FDA guarantees it will either approve or deny the drug application by a certain date.
A number of highly anticipated drugs have decision dates shortly after when FDA is expected to run out of funding to review drugs, according to data from BioMedTracker, a database of major drug decision dates.
Chief among them: Janssen’s esketamine nasal spray, a ketamine-based drug candidate, which has been held up as a potential breakthrough for treatment-resistant depression. FDA is due to make a decision on the drug in early March, according to BioMedTracker.
And the esketamine product isn’t the only drug FDA has promised to review in March. Sanofi is awaiting a decision on Zynquista, a therapy that could be, if it is approved, the first oral drug to help control type 1 diabetes. Novartis is also expecting a decision on its multiple sclerosis drug candidate, Mayzent.
Janssen, Novartis and Sanofi all told STAT they had not yet received word from FDA that their applications would be delayed. “We are staying in close communication with the FDA and evaluating all of our projects should the shutdown persist long-term,” Novartis spokeswoman Sofina Mirza-Reid told STAT.
Aerie Pharmaceuticals, Jazz Pharmaceuticals, Glenmark Pharmaceuticals, Recro Pharma, Sage Therapeutics, Circassia, Roche and UCB all have their own decision dates in March, according to BioMedTracker. Those potential therapies would treat a variety of conditions, including glaucoma, diabetes and sleep apnea.
Those drug makers aren’t the only ones likely to be directed off course if FDA’s user fee funding runs out.
Any full interruption in work will likely lead to a backlog of drug applications to review, meaning approval decisions set for later this year could also slip, even after the government reopens. That means the agency may also delay its consideration of drugs like GlaxoSmithKline’s two-drug HIV/AIDS treatment, Tivicay/Epivir, for which a decision is due in mid-April.
Adding to the potential delays is the fact that FDA cannot accept any new drug applications while it’s shutdown, meaning any potential applications that would have been filed since late December will be added to the processing list all at once — further adding to the crunch.
And approval decisions aren’t the only thing impacted by a potential user fee program shutdown. FDA also conducts key meetings to give drug makers the chance to discuss their drug development process with regulators. Eli Lilly, for example, has a meeting slated for late February to discuss a potential Alzheimer’s drug, according to BioMedTracker. Those meetings would also likely be canceled, should FDA run out of money.
“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.” About the Authors
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