March 08, 2023

Duckworth Leads Letter Calling on Walgreens to Clarify that Mifepristone Dispensing Decisions Remain Undecided and Premature as it Seeks FDA Certification

 

[WASHINGTON, D.C.] — U.S. Senator Tammy Duckworth (D-IL) led eleven colleagues in sending a letter to Walgreen’s CEO Rosalind Brewer to express strong opposition to Walgreens’ premature decision to publicly declare its intent to avoid dispensing Mifepristone—a FDA-approved medication for termination of pregnancy and used to treat miscarriages—in certain states. The letter also urges the company put patients first by quickly obtaining the FDA specialty certification to dispense this medication and, following that, issue further clarification that no final decisions on dispensing Mifepristone have been made for any state.

In part, the Senators wrote: “Ensuring women have access to Mifepristone—medication the FDA approved more than two decades ago for medical termination of pregnancy and treatment of miscarriages—is a critical step in preserving every woman’s right and freedom to make reproductive health choices in consultation with her healthcare provider.”

U.S. Senators Maria Cantwell (D-WA), Richard Durbin (D-IL), Martin Heinrich (D-NM), Edward J. Markey (D-MA), Jeff Merkley (D-OR), Alex Padilla (D-CA), Jacky Rosen (D-NV), Brian Schatz (D-HI), Raphael Warnock (D-GA), Peter Welch (D-VT) and Sheldon Whitehouse (D-RI) joined Duckworth on this effort. Their letter comes after reports late last week that Walgreens will not dispense Mifepristone in several states due to pressure from Republican Attorneys General with fringe interpretations of federal law – despite the fact that many complicated legal questions surrounding the interplay of federal and state laws related to Mifepristone remain open and subject to active litigation.

They continued: “By prematurely revealing potential Mifepristone dispensing policies for specific states, Walgreens—intentionally or unintentionally—created a perception that the company concurs with controversial interpretations of complex constitutional and legal issues related to federal and state statutory interpretation. […] A major retail pharmacy prematurely wading into complicated and controversial legal matters threatens to undermine public trust and confidence in retail pharmacies and pharmacists. The industry will ultimately be harmed if the public comes to view retail pharmacies as corporate entities that prioritize responding to partisan pressure and threats over patient care.”

Full text of the letter can be found here and below.

Dear Ms. Brewer:

We write to express our strong opposition to Walgreens’ premature decision to publicly state its intent to avoid dispensing Mifepristone—which the U.S. Food and Drug and Administration (FDA) approved to be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber—in certain States.

Ensuring women have access to Mifepristone—medication the FDA approved more than two decades ago for medical termination of pregnancy and treatment of miscarriages—is a critical step in preserving every woman’s right and freedom to make reproductive health choices in consultation with her healthcare provider. 

We commend Walgreens for seeking pharmacy certification to dispense Mifepristone through FDA’s Mifepristone risk evaluation and mitigation strategy (REMS) program. However, given that such pharmacy certification remains pending, it was ill-advised, at best, for Walgreens to publicly engage in signaling hypothetical regional dispensing decisions over a medication it is not yet authorized to dispense in any State.

By prematurely revealing potential Mifepristone dispensing policies for specific States, Walgreens—intentionally or unintentionally—created a perception that the company concurs with controversial interpretations of complex constitutional and legal issues related to Federal and State statutory interpretation; Federal preemption; judicial precedent and standing, among other complicated matters. Such action was particularly misguided since many of the complicated legal questions remain open and subject to active litigation.

The fear that partisan actors may seek to inaccurately portray Walgreens’ premature disclosure of hypothetical dispensing decisions as endorsing specific statutory interpretations and specific legal theories concerning the complex interplay of Federal and State law is not itself hypothetical. The Kansas Attorney General touted Walgreens’ written response in a February 21, 2023, letter addressed to another retail pharmacy:

“Finally, as you may be aware, Walgreens has recently reviewed the laws at issue and has stated that it does not intend to dispense Mifepristone within the State of Kansas and does not intend to ship Mifepristone into Kansas from any of its pharmacies.”

A major retail pharmacy prematurely wading into complicated and controversial legal matters threatens to undermine public trust and confidence in retail pharmacies and pharmacists. The industry will ultimately be harmed if the public comes to view retail pharmacies as corporate entities that prioritize responding to partisan pressure and threats over patient care.

We urge Walgreens demonstrate its commitment to putting patients first by prioritizing obtaining FDA specialty certification to dispense Mifepristone and publicly clarifying that any hypothetical dispensing decisions remain undecided and premature at best, while the company seeks pharmacy certification.

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