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US FDA shutdown starts taking casualties, interrupting drug marketing plans

Biotech Aimmune Therapeutics Inc.'s peanut allergy drug became one of the early casualties of the U.S. Food and Drug Administration's ongoing partial shutdown, which hit its 25th day on Jan. 15.

The drugmaker said in a Jan. 14 filing that the FDA told the company the regulatory work on its marketing application for its experimental oral immunotherapy to treat peanut allergy in pediatric patients was on hold until the shutdown ends — a timeline that is uncertain.

Aimmune submitted its biologics license application for AR101 on Dec. 21, 2018, just hours before the shutdown started at midnight.

The company indicated it was seeking a priority review under the Prescription Drug User Fee Act — funds intended to help cover the costs of the regulatory review work for novel medicines.

It is unclear, however, if the FDA received fees from Aimmune before the partial shutdown started on Dec. 22, 2018, when the agency furloughed over 7,000 employees, or 41% of its staff.

On Jan. 14, FDA Commissioner Scott Gottlieb acknowledged his agency was receiving "many questions" related to "one particular biotech firm," though it is unclear if he meant Aimmune or another company.

Gottlieb said he could only address inquiries "generally, and not specific to one product."

Since the shutdown started, the commissioner has tried to reassure drugmakers the user fees the agency had on hand would allow it to continue its work on marketing application reviews and approvals.

"If the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application," he tweeted on Jan. 14.

Gottlieb has repeatedly emphasized, however, that during the shutdown, the FDA cannot accept any new user fees nor any applications that require a fee.

For products not covered by a user fee program, like most blood and allergenic extract products, the FDA does not have carryover funding to continue reviewing pending or accepting new applications, he said.

It is unclear whether other companies that submitted marketing applications to the FDA days before the shutdown could be in line for the same fate as Aimmune.

Alkermes PLC and its partner Biogen Inc. reported on Dec. 17, 2018, that they had delivered their application for their multiple sclerosis treatment BIIB098 to the FDA.

A number of companies are expecting to hear from the FDA in the next few months on whether they can market their drug products in the U.S., including Jazz Pharmaceuticals PLCJohnson & Johnson, Novartis AG, Sage Therapeutics Inc. and Sanofi, among others.

Five weeks funding for new drug reviews

On Jan. 7, Gottlieb said the FDA had about one month's worth of user fees banked for its regulatory work for new drug applications. But on Jan. 14, he revised that estimate, increasing it to about five weeks' worth of those funds currently left on hand.

"This could change," but not by more or less than one week, the commissioner said on Twitter — the primary platform he has used to communicate with the public during the shutdown.

Gottlieb said his five-week estimate assumed the FDA could continue to work through the existing workload of applications and other review-related functions.

"We haven't scaled back programs," he tweeted.

On Jan. 12, Gottlieb said the FDA would provide an update this week on the remaining balances of the new drug fees and was evaluating when we the agency would cross a threshold, "beyond which, we have to declare that we will not be able to meet medical product user fee goals for 2019."

He did not respond to a question from S&P Global Market Intelligence about when he would provide that information.

Nearly three dozen Democratic senators also want to know the answer to that and other questions and have asked Gottlieb to respond by Jan. 18.

The commissioner provided some insight about the FDA's inspections, saying on Twitter the agency would be restarting them for high-risk food and medical product facilities as early as Jan. 15.

Sampling assignments at ports of entry were re-started on Jan. 14, he added.

Stretching funds

Gottlieb said the FDA has stretched its carryover drug user fees "to get a longer runway should the shutdown continue, by for example, sharply reducing any overhead charges" to the agency's drug centers.

"The slower burn rate gives us about five weeks left as of this week," Gottlieb tweeted.

"We've stretched our resources by lowering burn by basically deferring internal operating charges and shifting money to salaries," the FDA chief wrote.

He said the agency was "shifting operating dollars to payroll dollars" to maximize its runway and preserve program functions.

Gottlieb also noted the FDA had about "three months of runway" on the medical device side, though he said the agency was still working through its final numbers.