Jan 15, 2019

The shutdown is straining the FDA

FDA Commissioner Scott Gottlieb. Photo: Chip Somodevilla/Getty Images

The partial government shutdown is beginning to cramp the Food and Drug Administration’s ability to review new drugs, and those effects will only grow more pronounced if the shutdown continues to drag on.

Driving the news: Aimmune Therapeutics, a company that’s seeking approval for a new drug to help children with peanut allergies, said in a financial filing yesterday that the FDA won’t be able to review its product until the government reopens.

How it works: Aimmune's product is an outlier — the FDA can only review allergy drugs when Congress provides funding. For other types of drugs, pharmaceutical companies pay the FDA a fee when they submit new products for approval, and those fees fund the review process.

  • But those products could also feel a squeeze, because the FDA can’t accept new fees or applications during the shutdown.
  • FDA commissioner Scott Gottlieb said yesterday the agency has moved some money around and can keep the review process going for roughly another five weeks.

What’s next: Several drugs could be left hanging in the balance if the FDA reaches the end of that five-week "runway" and the government is still shut down, STAT reports.

  • They include a potential depression treatment from Janssen Pharmaceuticals, a diabetes drug from Sanofi, and a multiple sclerosis drug from Novartis.
  • If the shutdown continues, it could also create a backlog of reviews that would affect drugs slated for an approval decision later this year, STAT reports, including an HIV/AIDS drug.

On the bright side, the FDA will resume its inspections of high-risk food processing plants, using unpaid inspectors.

Go deeper: All the ways Americans are feeling the effects of the shutdown

Editors' note: This story has been updated to clarify that the FDA's review of Aimmune's product would not be covered by industry fees.

Go deeper

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 8 p.m. ET: 857,487 — Total deaths: 42,107 — Total recoveries: 178,034.
  2. U.S.: Leads the world in confirmed cases. Total confirmed cases as of 8 p.m. ET: 188,172 — Total deaths: 3,873 — Total recoveries: 7,024.
  3. Business updates: Should you pay your rent or mortgage during the coronavirus pandemic? Find out if you are protected under the CARES Act.
  4. Public health updates: More than 400 long-term care facilities across the U.S. report patients with coronavirus — Older adults and people with underlying health conditions are more at risk, new data shows.
  5. Federal government latest: President Trump said the next two weeks would be "very painful," with projections indicating the virus could kill 100,000–240,000 Americans.
  6. U.S.S. Theodore Roosevelt: Captain of nuclear aircraft carrier docked in Guam pleaded with the U.S. Navy for more resources after more than 100 members of his crew tested positive.
  7. What should I do? Answers about the virus from Axios expertsWhat to know about social distancingQ&A: Minimizing your coronavirus risk.
  8. Other resources: CDC on how to avoid the virus, what to do if you get it.

Subscribe to Mike Allen's Axios AM to follow our coronavirus coverage each morning from your inbox.

World coronavirus updates: UN warns of recession with "no parallel" to recent past

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's Health Ministry. Note: China numbers are for the mainland only and U.S. numbers include repatriated citizens and confirmed plus presumptive cases from the CDC

The novel coronavirus pandemic is the "greatest test" the world has faced together since the formation of the United Nations just after the Second World War ended in 1945, UN chief António Guterres said Tuesday.

The big picture: COVID-19 cases surged past 856,000 and the death toll exceeded 42,000 Tuesday, per Johns Hopkins data. Italy reported more than 12,000 deaths.

Go deeperArrowUpdated 59 mins ago - Health

White House projects 100,000 to 240,000 U.S. coronavirus deaths

President Trump said at a press briefing on Tuesday that the next two weeks in the U.S. will be "very painful" and that he wants "every American to be prepared for the days that lie ahead," before giving way to Deborah Birx to explain the models informing the White House's new guidance on the coronavirus.

Why it matters: It's a somber new tone from the president that comes after his medical advisers showed him data projecting that the virus could kill 100,000–240,000 Americans — even with strict social distancing guidelines in place.

Go deeperArrowUpdated 2 hours ago - Health