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.
The FDA’s March 2023 REMS document for mifepristone specifically states:
To become specially certified to prescribe mifepristone, healthcare providers must have the following qualifications:
a) Ability to assess the duration of pregnancy accurately
b) Ability to diagnose ectopic pregnancies
c) 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.
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. Thank you, FDA Office of Media Affairs.”
FDA response to Live Action News question on states stockpiling abortion pills they respond no comment 2
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.
Who can distribute abortion pills?
In 2020 under the COVID 19 pandemic, a preliminary injunction allowed pharmacies to act as “an agent” of the certified abortion pill prescribers and to store abortion pills “on behalf of the healthcare provider.” That language seemed to imply a strict oversight over who could and could not obtain and dispense the drugs. In that case, while the order allowed a pharmacy to stock and subsequently mail abortion pills for a certified prescriber, it limited the business from “acting as a retail pharmacy” and stocking the abortion pills generally or distributing the abortion pill outside of certified prescribers.
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 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.
The question Live Action News wanted clarified by the FDA was whether “non-medical agencies… can be certified to prescribe Mifeprex” — 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?”
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.
The FDA has granted all policing power over who is certified or de-certified as a prescriber to those who profit from the drug — namely to Danco or GenBioPro (GBP), the abortion pill’s respective name brand and generic manufacturers. In Live Action News’ “Bad Actors” series, we documented how Danco and GenBioPro have been turning a blind eye to the many ways that Big Abortion has flouted the REMS.
Who is stockpiling mifepristone?
The states listed below happen to also be plaintiff states listed in a Washington state lawsuit, where U.S. District Judge Thomas O. Rice recently granted a preliminary injunction to bar the FDA from “altering 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. § 355-1 in Plaintiff States.” States protected by the ruling include Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont.
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:
Massachusetts: On April 10, 2023, Governor Maura T. Healey announced that the state had “purchased approximately 15,000 doses of mifepristone to ensure sufficient coverage in the state for more than a year” and added, “Health care providers in Massachusetts have also agreed to purchase additional quantities to make available for patients.”
“At the Governor’s 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 stated.
Before the ruling, I asked @UMass to purchase 15,000 doses of mifepristone. That’s over a year’s worth of doses that we expect to have in hand this week. We’ve also been in touch with other health care providers ordering additional quantities to make available for patients.
— Maura Healey (@MassGovernor) April 10, 2023
Washington state: On April 4, 2023, Govenor Jay Inslee announced that the state had “taken unprecedented action to purchase a three-year supply of mifepristone…” and that Inslee had “directed the state Department of Corrections, using its existing pharmacy license, to purchase the medication last month. The full shipment was delivered on March 31,” the state claimed.
According to the Associated Press, “The Democratic governor said he ordered the Department of Corrections, which has a pharmacy license, to buy 30,000 doses of the generic version of mifepristone at a cost of about $1.28 million, or $42.50 per pill.”
Governor Jay Inslee has also vowed to continue to dispense abortion pills regardless of the decision by the Supreme Court.
Governor Jay Insee tells MSNBC’s Symone that Washington state will continue to distribute Mifepristone even if the Supreme Court decides to side with the Texas judge’s ruling of removing access to this abortion pill.
(cont) #WomensRightsAreHumanRights pic.twitter.com/qwrd8AHusM
— IT’S TIME FOR JUSTICE (@LiddleSavages) April 17, 2023
Maryland: On April 17, 2023, Gov. Wes Moore announced that the state of Maryland had “begun the process of stockpiling the drug mifepristone as the federal courts wrestle over the U.S. Food and Drug Administration’s long-standing approval of the medicine, one of the pills prescribed for medication abortions.”
Oregon: Gov. Tina Kotek’s office said in an email to CNN that she has directed the Oregon Health Authority to “explore all available avenues for ensuring Oregon is prepared should Mifepristone become less available. That includes evaluating the supply of Mifepristone and Misoprostol and consulting with providers to better understand the potential impact on the provision of abortion and reproductive health care and what additional support might be necessary.”
Maine: Governor Janet Mills said that her Administration is “evaluating options, including procuring mifepristone if needed, to protect access to medication abortion for Maine women.” However, Maine is not listed in the Washington state lawsuit and would likely be under all pre-2016 FDA abortion pill regulations for the drug should the Supreme Court uphold a 5th Circuit Appeals Court ruling issued last week.
“I sometimes worry that if people keep talking about stockpiling there will be a rush for all these drugs and it will drive up prices for everybody,” Connecticut Gov. Ned Lamont, told the Wall Street Journal.
Who is stockpiling misoprostol?
States not listed as plaintiff states in the previously mentioned Washington state ruling seem to be purchasing stockpiles of misoprostol, the second drug in the abortion pill regimen. Due to a potential threat of loss of access to mifepristone, abortion providers have pivoted to a less effective and unapproved one-drug regimen of misoprostol only.
As a result of recent legal wranglings, pro-abortion states are also buying up stockpiles of misoprostol. These include:
California: On April 10, 2023, Governor Gavin Newsom announced that the state had purchased an “emergency stockpile of up to 2 million pills of Misoprostol.” Then on April 18, 2023, Governor Newsom also announced that the state would be willing to flout a Supreme Court order which “suspends the drug’s FDA approval.”
New York: On April 14, 2023, Governor Kathy Hochul announced that New York would be “stockpiling 150,000 doses of Misoprostol.”
