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House GOP's growing discontent with the FDA

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Republicans in Congress are increasingly fed up with the FDA, setting the stage for a bigger backlash if they're not satisfied with how the agency reacts to the recent District Court decision revoking its approval of mifepristone.

Why it matters: The frustration adds to the difficult choices facing the agency, as it has met with calls from progressives to ignore the court.

Driving the news: A group of 69 Senate and House Republicans filed an amicus brief Tuesday asking the 5th U.S. Circuit Court of Appeals not to stay the ruling, charging that "[t]he FDA's unlawful approval and deregulation of chemical abortion drugs subverts Congress' public policy considerations and safeguards for patient safety."

The big picture: The mifepristone ruling comes after a tough stretch for the FDA: Controversy around the infant formula shortage, fast-tracked approval of Alzheimer’s drugs and the COVID-19 vaccine has riled up GOP lawmakers.

  • Democrats, sensing the political upper hand, have been more vocal than Republicans in the wake of the latest ruling. But 67 congressional Republicans also signed an amicus brief in February that supported the lawsuit in which the Texas judge banned the use of mifepristone.

What’s next: Although the administration has already said it won’t flat-out ignore the Texas ruling, Rep. Tony Gonzales has suggested defunding the FDA if it doesn’t follow the judge’s orders.

  • One former GOP staffer said Rep. Andy Harris, who chairs the subcommittee that handles FDA appropriations, won’t hesitate to cut the agency’s funding if he feels it’s being political. (Harris’ office did not respond to a request for comment. The congressman has not released a statement on the Texas ruling.)
  • “I don't think it would be to defund the entire FDA because I think most people are cognizant that FDA has a valuable important role to play,” the former staffer said. “But if they want to be political … well fine, then there’s going to be consequences.”

Flashback: Some Senate Republicans were dissatisfied with FDA Commissioner Robert Califf during his 2022 Senate confirmation process, citing issues with the agency loosening restrictions on mifepristone.

  • But Roger Severino, vice president of domestic policy at the Heritage Foundation, said the growing frustration with the FDA predates Califf, citing the FDA’s approval of the abortion pill as when the agency’s politicization “went into overdrive.”
  • Mifepristone was first approved by the FDA in 2000.
  • “This spanned multiple presidents. The FDA sees itself as its own independent fiefdom in many ways,” Severino said.
  • “So we now have several instances in several areas where the FDA has let politics infect its decision-making. And if they don't shape up, then Congress should definitely step in and fix it.”

What they’re saying: “We need to quickly remedy what is not working in the Agency, institute needed reforms, and restore public confidence,” Harris said when Califf came to testify in front of the Agriculture, Rural Development and Food and Drug Administration appropriations subcommittee in late March.

The other side: “The FDA has a long history of working cordially with all members of Congress to engage on a number of important topics related to the agency’s science-driven mission to protect and promote public health — and we continue to do so,” an FDA spokesperson wrote in an email.

Of note: House Oversight Republicans have pressed the FDA on both baby formula shortages and its tobacco and nicotine regulatory programs in the last month alone.

  • “We have deep concerns that [the Center for Tobacco Products’] decisions have been influenced by political concerns rather than scientific evidence,” the lawmakers said in a letter led by committee Chair James Comer.
  • Select Subcommittee Chair Brad Wenstrup and Comer also sent a letter to the FDA in March asking for information on Pfizer’s COVID-19 vaccine full approval, charging that the “Biden Administration’s political interference in the impartial vaccine approval process is a recurring theme.”
  • And Energy and Commerce sent a March letter requesting information on ongoing drug shortages and asking whether the agency is “effectively using its existing authorities” for accessing information on the shortages.
  • E&C leaders sent another letter in March questioning the agency's funding of gain-of-function research.

Yes, but: Dissatisfaction with the FDA and the view that it is exceeding its authority may not be shared by all Republicans, said Peter Pitts, a former FDA associate commissioner who served during President George W. Bush’s administration.

  • “Members of Congress, just like the people they represent, don’t always understand the FDA,” Pitts said. “But those that are on Energy and Commerce in the House or HELP in the Senate, the committees that have jurisdiction — they have a much better understanding of what the FDA does.”
  • Energy and Commerce Chair Cathy McMorris Rodgers and Health subcommittee Chair Brett Guthrie sent out a statement Monday that appears to toe the line between their anti-abortion beliefs and FDA authority.
  • “We must remain committed to the fundamental principle that every life is worth living. The FDA's first and most important job is to ensure the safety of the American people. As the courts review the cases at hand, we must not lose sight of this directive,” the two wrote in the statement.
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