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US FDA furloughing more staff in shutdown, halting drug advisory panel meetings


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US FDA furloughing more staff in shutdown, halting drug advisory panel meetings

U.S. Food and Drug Administration Commissioner Scott Gottlieb said he is sending more of his workers home during the government shutdown, adding to the more than 7,000 employees who were furloughed about four weeks ago.

The commissioner said he is also halting FDA advisory committee meetings — public hearings where scientific experts discuss the efficacy and safety of experimental therapies and provide their recommendations for approval or evaluate the risks of certain products.

The last drug advisory committee on the FDA's schedule was held on Jan. 17 for Sanofi's and Lexicon Pharmaceuticals Inc.'s experimental diabetes medicine Zynquista.

The news of more furloughed FDA staff, reported first by The Washington Post, comes just days after Gottlieb said he was bringing about 400 food and drug inspectors back to work, though without pay.

The government shutdown has now lasted 28 days — the longest in U.S. history, far surpassing the previous record of 21 days that went from Dec. 16, 1995, to Jan. 6, 1996.

The shutdown started on Dec. 22, 2018, when the then-Republican-controlled House refused to take up a Senate-adopted bill to fund 25% of federal agencies, including the FDA.

Even though the FDA is part of the Department of Health and Human Services, which was funded last fall for fiscal 2019, the food and drug agency's appropriations are funneled through the U.S. Agriculture Department, which was caught in the shutdown.

In the past few weeks, the Democratic-controlled House has adopted multiple bills in an attempt to re-open the shuttered agencies, most recently on Jan. 17, when it approved a measure by voice vote that would provide funding through Feb. 28.

Senate Majority Leader Mitch McConnell, R-Ky., however, has no plans to take up the bill because it does not include the $5.7 billion that President Donald Trump has demanded for a border wall between the U.S. and Mexico — the dispute at the heart of the shutdown.

Gottlieb did not say how many more FDA workers are being sent home. The FDA has repeatedly declined to disclose the number of additional employees who have been or soon will be furloughed beyond the initial 7,053 workers, or 41% of the agency's staff, who were told not come to work since the shutdown started.

The HHS contingency plan, dated Dec. 19, 2018, has not been updated.

Impact to industry uncertain

Gottlieb told the Post on Jan. 17 the furloughs were necessary so the FDA could preserve the funds it has on hand to be able to keep moving forward on reviews of new drug applications.

In a Jan. 15 tweet on Twitter — the primary platform Gottlieb has been using to communicate with the public during the shutdown — the commissioner said the FDA had about four to five weeks' worth of user fees it collects from brand-name drugmakers left to help with the agency's review work on new medicine applications.

The FDA is not allowed to collect user fees during the shutdown.

Stephen Ubl, the president and CEO of the Pharmaceutical Research and Manufacturers of America, a lobbying group for the brand-name drug industry, said it was too early to know the full impact of the ongoing shutdown on the biopharmaceutical sector.

While Gottlieb is doing an "exceptional job" in watching out for drugmakers during the FDA's partial closure, "he's going to run out of resources eventually," Ubl told reporters during a Jan. 16 briefing in Washington.

One drugmaker, Aimmune Therapeutics Inc., reported on Jan. 14 that the FDA told the biotech the regulatory work on its application to market an oral immunotherapy to treat peanut allergy was put on hold until the shutdown ended.

A spokeswoman for Aimmune told S&P Global Market Intelligence the company had paid $2.5 million in user fees to the FDA a week before the shutdown started — money the agency accepted and has not communicated was paid in error.

In a series of unusual tweets on Jan. 14 and 15, however, Gottlieb said allergenic products are not covered by user fee programs.

The commissioner said his tweets were in response to questions about "one particular biotech," though he did not name Aimmune.

The FDA is prohibited from disclosing information about a company's pending application.

Aimmune said it continues to seek clarification from the agency — a communication that may now have to wait until the shutdown is over.

The company has had a close working relationship with the FDA, going back to when the biotech was formed in 2011 — a venture that came about after Aimmune's founders met with U.S. regulators, researchers from the National Institutes of Health and patient advocates, who discussed the need to pursue a peanut allergy treatment.

Even if the FDA forces Aimmune's product to take the standard non-user fee route, Credit Suisse analyst Vamil Divan said the medicine may still be assured a speedy pathway to the U.S. marketplace because it has received fast-track status and breakthrough designation — processes intended to expedite the reviews of drug marketing applications.

A number of companies have applications waiting on decisions from the FDA in the coming months, including Sanofi, Merck & Co. Inc., Novartis AG and Novo Nordisk A/S, among others.

In his Jan. 15 tweets, Gottlieb said some parties were using "the excuse" of the shutdown to "advance misleading narratives" and said he feared there would be other instances in which the closure was "inadvertently or deliberately" blamed.