FDA launches safety study for abortion pill mifepristone, source says

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The Food and Drug Administration has launched a information survey of the abortion pill mifepristone, a elder FDA authoritative confirmed to CBS News, a measurement that could pave the mode for the Trump medication to restrict entree to the medication.

It volition beryllium a retrospective survey of hundreds of thousands of cases, according to the official. The interim results of the survey could beryllium released successful July, but the authoritative noted the timing of the last results volition beryllium connected the plan of a secondary investigation aft the interim results travel in.

The Wall Street Journal was archetypal to study connected the motorboat of the study.

Last September, Health and Human Services Secretary Robert F. Kennedy Jr. wrote successful a missive to respective Republican authorities attorneys wide that the FDA was reviewing the information of mifepristone.

At the time, Kennedy and then-FDA Commissioner Martin Makary wrote, "HHS — done the FDA — is conducting its ain reappraisal of the evidence, including real-world outcomes and evidence, relating to the information and efficacy of the drug." 

The cause came nether renewed scrutiny aft the Biden medication issued a memorandum lifting restrictions that required the cause to beryllium dispensed in-person and giving entree to mifepristone via telehealth and by mail.

Last year, the authorities of Louisiana filed a suit challenging the FDA's determination to let mifepristone to beryllium delivered by mail.

On May 4, the U.S. Court of Appeals for the 5th Circuit temporarily reinstated the regularisation requiring mifepristone to lone beryllium dispensed successful person.

However, the pursuing week, the Supreme Court set speech the little tribunal order and allowing, for now, mifepristone to proceed to beryllium delivered to patients done the message portion the Louisiana lawsuit plays retired successful the courts.  

Mifepristone, which was archetypal approved by the FDA successful 2000 arsenic a harmless mode to extremity aboriginal pregnancies, is typically taken with a 2nd drug, misoprostol.

Asked past twelvemonth whether a reappraisal of mifepristone could pb to a ban, CBS News aesculapian contributor Dr. Celine Gounder suggested it would beryllium hard for the FDA to retreat approval, an bonzer measurement that would rapidly gully ineligible challenges. 

However, Gounder said that depending connected what the information reappraisal finds, it could marque entree much difficult, limiting the drug's availability done telehealth oregon by mail, oregon restricting the quality to prescribe it to doctors, alternatively than doc assistants oregon nurses who are besides presently capable to prescribe it.

Kathryn Watson and Melissa Quinn contributed to this report.

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