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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

Justice Department closes Emmett Till murder probe

A faded photograph is attached to the headstone that marks the gravesite of Emmett Till in Burr Oak Cemetery in Chicago, Illinois. Photo: Scott Olson via Getty Images

The family of Emmett Till announced Monday that the Department of Justice has formally closed its second investigation into the 1955 murder of Emmett Till.

Why it matters: The DOJ reopened the probe in 2018 after the white woman at the center of the case reportedly recanted her allegation that Till, a Black 14-year-old, sexually harassed her prior to his murder.

GOP Rep. Devin Nunes to retire, will be CEO of Trump media org

Rep. Devin Nunes. Photo: Dylan Hollingsworth/Bloomberg via Getty Images

Rep. Devin Nunes (R-Calif.), who serves as the top Republican on the House Intelligence Committee, will retire at the end of the year and become CEO of Trump's new media organization.

Why it matters: Nunes, once considered a moderate member of the party, became one of the fiercest defenders of former President Donald Trump throughout both of Trump's impeachments and the Intel committee's Russia investigation.

DOJ cites discrimination in lawsuit against Texas over voting districts

Attorney General Merrick Garland. Photo: Alex Wong/Getty Images

The Department of Justice on Monday filed a lawsuit against Texas, alleging Republican state lawmakers discriminated against Black and Latino voters and has "again diluted the voting strength of minority Texans" when they approved new redistricting maps.

Why it matters: A DOJ assessment of the new districts found that they violate Section 2 of the Voting Rights Act, Attorney General Merrick Garland said at a press conference.