Four AGs ask FDA to ease burdens on Mifestiprone abortion drug therapy

  

RFK, Jr.swears in FDA Commissioner

Nartin Makary, MD

Four AGs ask FDA  to ease burdens on Mifestiprone abortion drug therapy

The landmark Dobbs v. Jackson Women's Health case   overturned the 1973 Roe v. Wade decision declaring abortion (before viability) to be a personal, Constitutional right.  It left the decision to the states which are deeply divided.  Most abortions now are medical via the Mifepristone/misoprostol regimen.  The net result of reliance on the Mifestiprone/Misoprostol  pharmaceutical regimen is that despite Dobbs abortions in the U.S. have not declined.

There is, of course, opposition to use of the mails and telemedicine by prosecutors in states that bar abortion.  Robert F. Kennedy, Jr., responding to inquiry by 22 Republican Attorneys General has announced he will commence a new safety study.  The Mifepristone regimen has been a target of conservative Catholics like Harvard Law's Adrian Vermeule and his Irish collaborator Conor Casey.  [See *Comstock Act Bars Mailing of Mifepristone .]  

Since 2001 Mifepristone has been available for termination of pregnancy.  It is currently approved by the FDA as generally safe and effective  up to ten weeks gestation.  However for the past twenty years FDA has imposed its Risk Evaluation and Mitigation Strategy which imposes special licensing requirements on pharmacies and patent consent forms. [See FDA Q&A, item 11]

The FDA, to the surprise of many, has now approved a generic version of Mifepristone.

But the persistence of the specialised prescribing requirements has led four states to file a 53 page legal brief styled a Citizen Petition. The attorneys general of  Massachusetts, New York, New Jersey, and California  emphasize the burdens posed by the FDA on providers and patients .  Emphasizing the long established safety of the Mifestiprone medicinal regimen, the AGs call for removal of the long-imposed "risk evaluation and mitigation strategy" [REMS]:

  

The four Attorneys General, All Democrats, write:

  Based on 25 Years of Evidence and Safe Use, Mifepristone Does Not Need a REMS Program 

Based on mifepristone’s extensive safety record established over the last 25 years and the important and often critical benefits that the medication provides patients, the restrictive Mifepristone REMS Program should be eliminated because: 

(A) the current Mifepristone REMS is medically unjustified under the REMS statutory factors; 

(B) mifepristone’s safety has remained stable even as its restrictions have been lessened; 

(C) the Mifepristone REMS Program   is unduly burdensome on patients, providers, pharmacies, and states’ healthcare delivery system; and

 (D) its continuation cannot be squared with the FDA’s lack of REMS programs on drugs that have significantly more risks than mifepristone. Thus, FDA should eliminate the Mifepristone REMS Program and treat mifepristone consistent with other safe, effective medications used by millions of people.