Drugs

Kennedy, Makary Pledge Mifepristone Review

In a 9/19 letter to 20 Republican attorneys general, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Martin Makary say FDA is leading a review of the medication abortion drug mifepristone. Kennedy and Makary wrote in response to a 7/31 letter from the attorneys general raising concerns about the drug, based in part on a study by the Ethics and Public Policy Center.

Kennedy and Makary say FDA is “conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug. Given the 2016 FDA decision to eliminate the REMS (Risk Evaluation and Management Strategy) requirement for certified prescribers to report non-fatal serious adverse events to the mifepristone sponsors, this review will contribute to the understanding of the drug’s safety profile.”

The letter says that the Ethics and Public Policy Center report indicated potential dangers that may attend offering the medication abortion drug without sufficient medical support or supervision and that the concerns raised by the attorneys general merit close examination.

“FDA’s own data collected between 2000 to 2012 (sic) indicated 2,740 adverse events, including 416 events involving blood loss requiring transfusions,” the two write. “Since then, safeguards for women regarding the administration of mifepristone have been significantly reduced.”

In a response (includes a link to the Kennedy/Makary letter), the advocacy group Democracy Forward says the drug’s safety and efficacy have been well established over its 25 years of approval and use. “This attempt to undermine medication abortion comes at the same time that the anti-science community, emboldened by the president, is pushing junk science to spread misinformation about autism and the use of acetaminophen,” it says.

The group challenges the study cited by the attorneys general, describing it as “an anti-abortion funded effort with significant flaws in methodology and findings.” It says the federal government should “heed medically accurate, peer-reviewed, and evidence-based approaches to medication regulation and utilize the expertise that has been developed over decades by the non-partisan career civil service.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome