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New drug sponsors with March review goals are now on notice that a continued government shutdown may affect their applications, as the agency begins demonstrating how a user fee program will function absent appropriations and carryover funds.

Remaining carryover prescription drug user fee funds currently sustaining many product review activities are expected to run out between Feb. 17 and Feb. 28, Commissioner Scott Gottlieb said during a Jan. 22  town hall for CDER and CBER. The earlier date is the projected end, but the money may stretch to the later date.

Without carryover user fee revenue, activities related to applications in both centers will be further curtailed and potentially stop unless President Trump and congressional Democrats reach a deal and end the partial government shutdown.

There are at least 21 applications with pending review goals within or shortly after the PDUFA window closes. (See tables at end of story.)

Sponsors reached by the Pink Sheet did not indicate FDA is preparing them for the possibility of a delay or a change should the shutdown continue.

Sanofi, which in conjunction with Regeneron Pharmaceuticals Inc. has a March 11 user fee goal for an application expanding the indication forDupixent (dupilumab) to include treatment of adolescent patients 12 to 17 with moderate to severe atopic dermatitis, told the Pink Sheet that to the best of its knowledge "FDA plans to move forward and complete their review of our upcoming regulatory milestones as expected."

Sanofi and Lexicon Pharmaceuticals Inc.'s sotagliflozin, an SGLT1 and SLGT2 inhibitor proposed as an adjunct to insulin for type 1 diabetes, also has a March 22 user fee goal. (Also see "Sotagliflozin: A Potential Test Of Patient-Physician Decision-Making" - Pink Sheet, 22 Jan, 2019.)

AstraZeneca PLC, which along with Circassia Pharmaceuticals PLC has a March 31 review goal for a new claim for its long-acting muscarinic antagonist (LAMA)Tudorza (aclidinium) in chronic obstructive pulmonary disease, said "delays to review times would have a negative impact on patients awaiting new treatment options."

The two companies also have a March 31 goal forDuaklir (aclidinium and formoterol), a fixed-dose combination intended for twice daily treatment of COPD. "AstraZeneca pays user fees to help fund review activities and we would like to see the administration continue to support the important work of the FDA," a company spokesperson said.

Approvals, Guidance Writing Continues

The PDUFA carryover burn rate appears to have remained about the same in recent weeks. Gottlieb said Jan. 14 that there was about five weeks of funding left, projecting the end to be about Feb. 18, thanks to reductions in overhead.

If no deal to reopen the agency is imminent, agency staff could make a final push to complete as many reviews as possible before user fee funds expire and may act more aggressively than usual on some items.

ANDA and NDA and BLA supplement approvals in the days leading up to the shutdown suggest that staff made a push to finish as much work as possible. (Also see "Shutdown Week Four: FDA Maintains Pre-Shutdown Output Pace In Some Cases" - Pink Sheet, 14 Jan, 2019.)

FDA recently issued its first non-generic product approvals since the shutdown began Dec. 21. (Also see "Keeping Track: FDA's Review Actions Carry On During Shutdown" - Pink Sheet, 20 Jan, 2019.)

The agency also has issued several guidances in recent days, including two on Jan. 22: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway and S11 Nonclinical Testing in Support of Development of Paediatric Medicine, and another Jan. 23: Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection.

The guidances were issued even though there is no venue to formally announce their release. The agency said notices would be placed once the Federal Register is available.

Most likely, the guidances would have been released around now regardless of the shutdown. Gottlieb said in a tweet that the documents "generally were in very advanced stages of development" and nearing completion before the shutdown.

"It's the case that new guidance development is being affected by the lapse," he added.

FDA also held three advisory committee meetings during the shutdown, including two at its White Oak headquarters. (Also see "Scenes From A Shutdown: US FDA Hides It Well" - Pink Sheet, 21 Jan, 2019.)

Compounding Inspections Continue With Fee Balance Gone... 

All carryover compounding user fee money is already gone, meaning that compounder regulation is set to change substantially as operations are scaled back.

Gottlieb said in a tweet that the agency will continue some compounding facility inspections. "It will be excepted work, meaning our dedicated inspectors will not be paid for these assignments during the funding lapse, but compounding inspection work continues."

FDA said in the absence of carryover funding it is "generally not developing compounding policies." That would appear to include guidances and related documents.

Compounding has been a focus at FDA because of sterility and other problems found at various facilities and enforcement will remain a high priority in 2019. (Also see " US Enforcement 2019: Compounding, Opioids Top Priorities But Beware Of REMS Violations, Too " - Pink Sheet, 19 Dec, 2018.) FDA also recently issued Good Manufacturing Practice guidance for compounding outsourcing facilities producing drugs for office stock. (Also see "FDA’s Revised Draft For Compounding Pharmacies Opens Door To Compounding For Office Use " - Pink Sheet, 17 Dec, 2018.)

...While GDUFA Has 'Months' Left

Generics sponsors with pending applications likely have less to worry about in terms of shutdown-related productivity. The generic drug user fee program still has "months" of funding remaining, Gottlieb said.

Sponsors may be more concerned about FDA assigning all ANDAs submitted during the shutdown the same filing date once normal operations resume, which could impact 180-day exclusivity decisions. (Also see "US Federal Courts Can Operate Until Jan. 25; Patent Office Faces Eminent Closure Under Shutdown" - Pink Sheet, 16 Jan, 2019.)

The agency has not updated the status of the biosimilar user fee carryover balance.

Nearly One-Third Of FDA Staff Furloughed

Most FDA staff now are either furloughed, working but not paid, or in a partially paid status.

The agency said Jan. 18 that about 31% of its staff are furloughed, which would be nearly 5,500 of its 17,397 workers. Another 23% (nearly 4,000) are classified as partially exempt/excepted/furloughed, meaning they are paid for the exempt hours they have worked. About 9%, more than 1,500 workers, are in excepted status, meaning they are working but not paid.

Thirty-seven percent, more than 6,400 staffers, are considered exempt, meaning they are paid for the time worked.

Gottlieb also said during the Jan. 22 town hall 70% of the Office of Regulatory Affairs and 95% of the Center for Food Safety and Applied Nutrition has been furloughed.

FDA employees can receive an update of their current furlough status from noon to 3 p.m. Jan. 24 during an employee outreach event at the White Oak campus. Center directors, senior leadership, and agency administrative experts will be available to answer questions and provide resources, Gottlieb said in a tweet.

Shutdown plans indicated about 59% of the agency staff would be initially retained, the majority paid with carryover funds. (Also see "As US FDA Shutdown Continues, What Will Be The Cost Of Not Spending?" - Pink Sheet, 28 Dec, 2018.)

Products With Known User Fee Goals Potentially Threatened By The Partial Government Shutdown
Products With Undefined February Review Goals

Adapted from Pink Sheet's User Fee Goals Dates tracker

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