{"id":289461,"date":"2023-04-21T10:36:32","date_gmt":"2023-04-21T15:36:32","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=289461"},"modified":"2023-04-20T12:53:11","modified_gmt":"2023-04-20T17:53:11","slug":"states-stockpile-abortion-pills-violate-fda-safety","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/states-stockpile-abortion-pills-violate-fda-safety\/","title":{"rendered":"Could some states’ decisions to stockpile abortion pills violate FDA safety rules?"},"content":{"rendered":"
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Pro-abortion states are busy stockpiling the abortion pill mifepristone (Mifeprex), despite requirements under the U.S. Food and Drug Administration’s (FDA) REMS safety system that only certified prescribers be allowed to legally dispense the drugs. In response to a request for clarification on a state’s ability to legally obtain abortion pill stockpiles, the FDA has in essence refused to comment.<\/p>\n

The FDA’s\u00a0March 2023 REMS document<\/a> for mifepristone specifically states:<\/p>\n

To become specially certified to prescribe mifepristone, healthcare providers must have the following qualifications:<\/em>
\na) Ability to assess the duration of pregnancy accurately<\/em>
\nb) Ability to diagnose ectopic pregnancies<\/em>
\nc) Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.<\/em><\/p>\n

It is unclear how a state or any government agency fits this criterion for prescribers of abortion pills, so when Live Action News requested clarification from the FDA on this matter of the legality of states obtaining the pills, we were shocked to receive a simple response which read, “We do not have any comment to share.\u00a0Thank you,\u00a0FDA Office of Media Affairs.”<\/p>\n

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FDA response to Live Action News question on states stockpiling abortion pills they respond no comment 2<\/p><\/div>\n

This response is highly unusual for the FDA, which has been willing to answer media requests and clarifications from Live Action News multiple times in the past.<\/p>\n

Who can distribute abortion pills?<\/strong><\/p>\n

In 2020 under the COVID 19 pandemic, a preliminary injunction<\/a>\u00a0allowed pharmacies to act as \u201can agent\u201d of the certified abortion pill prescribers and to store abortion pills \u201con behalf of the healthcare provider.\u201d That language seemed to imply a strict oversight over who could and could not obtain and dispense the drugs. In that case<\/a>, while the order allowed a pharmacy to stock and subsequently mail abortion pills for a certified prescriber, it limited the business from \u201cacting as a retail pharmacy\u201d and stocking the abortion pills generally or distributing the abortion pill outside of certified prescribers.<\/p>\n

But even after 2023 changes to the FDA’s REMS enabled retail pharmacies to dispense the drugs, the REMS still appears to only permit two groups to prescribe or dispense abortion pills: Certified prescribers (who must meet the previously outlined requirements) and certified pharmacies<\/a> must “verify that the prescriber is certified by confirming their completed Prescriber Agreement Form was received with the prescription or is on file with the pharmacy” and they may “not distribute, transfer, loan or sell mifepristone except to certified prescribers or other locations of the pharmacy,” among other requirements.<\/p>\n

The question Live Action News wanted clarified by the FDA was whether “non-medical agencies… can be certified to prescribe Mifeprex” \u2014 and whether, under REMS, “can the State’s… pharmacy order Mifepristone (Mifeprex) and send the drugs to other state agencies, which are not certified prescribers?”<\/p>\n

In other words, Live Action News wanted the FDA to verify that state agencies now stockpiling abortion drugs are certified under the REMS, and to verify whether state university pharmacies ordering the drug on behalf of a state are certified under REMS and complying with restrictions not to transfer the drugs to non-certified prescribers.<\/p>\n

The FDA has granted all policing power over who is certified or de-certified as a prescriber to those who profit from the drug \u2014\u00a0namely to\u00a0Danco<\/a> or GenBioPro (GBP)<\/a>, the abortion pill’s respective name brand and generic manufacturers. In Live Action News’ “Bad Actors” series, we documented<\/a> how Danco and GenBioPro have been turning a blind eye to the many ways that Big Abortion has flouted the REMS.<\/p>\n

Who is stockpiling mifepristone?<\/strong><\/h3>\n

The states listed below happen to also be plaintiff states\u00a0listed<\/a>\u00a0in a Washington state\u00a0lawsuit,<\/a>\u00a0where U.S. District Judge Thomas O. Rice\u00a0recently granted a preliminary injunction to\u00a0bar the FDA<\/a>\u00a0from \u201caltering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. \u00a7 355-1 in Plaintiff States.\u201d States protected by the ruling include Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont.<\/p>\n

Out of those states, Live Action News was able to document that the following states had announced plans to purchase stockpiles of the abortion pill:<\/p>\n

Massachusetts<\/strong>: On April 10, 2023, Governor Maura T. Healey\u00a0announced<\/a>\u00a0that the state had “purchased\u00a0approximately 15,000 doses of mifepristone to ensure sufficient coverage in the state\u00a0for more than a year” and added, “Health care providers in Massachusetts have also agreed to purchase additional quantities to make available for patients.”<\/p>\n

“At the Governor\u2019s request, the University of Massachusetts and health care providers have taken action to stockpile doses of mifepristone, and the Governor is issuing an Executive Order confirming protections for medication abortion under existing state law,” the announcement<\/a> stated.<\/p>\n

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Before the ruling, I asked @UMass<\/a> to purchase 15,000 doses of mifepristone. That\u2019s over a year\u2019s worth of doses that we expect to have in hand this week. We\u2019ve also been in touch with other health care providers ordering additional quantities to make available for patients.<\/p>\n

— Maura Healey (@MassGovernor) April 10, 2023<\/a><\/p><\/blockquote>\n