ICYMI: Legal, Health and Patient Safety, and FDA Experts Discuss Widespread Impact of Mifepristone Restrictions on Health and Drug Distribution 

WASHINGTON – On Tuesday, FDA regulatory experts, and health and patient safety experts gathered to discuss the impacts of Alliance for Hippocratic Medicine v. FDA on access to mifepristone, a safe and effective medication used for abortion and miscarriage care. 

If the Supreme Court allows the Fifth Circuit Court of Appeal’s ruling to stand, it will severely compromise abortion access – drastically limiting the availability of mifepristone throughout  the country and creating unsustainable barriers to accessing the drug. 

Experts also spoke to the dangerous precedent the decision creates, the threat it poses for  drug innovation and development, and their concerns for other medications nationwide. 

Carrie Flaxman, Senior Director, Public Policy Litigation & Law at Planned Parenthood gave an overview of the case and how the Court’s decision could make the majority of mifepristone disappear overnight. 

“This is not just about different labeling or going back to old REMS requirements. The 5th Circuit’s decision would be every bit as disruptive as the district court’s decision in terms of people’s ability to get mifepristone…If the Supreme Court doesn’t step in and block the decisions below, the majority of the mifepristone supply could disappear.  

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This judicial ping-pong game is impacting the accessibility of a safe, effective, decades-long approved medication and is causing chaos and confusion. Patients deserve to access the medication they need and providers should be able to provide that medication without unnecessary interference from the judiciary, or politicians for that matter.”

Dr. Ushma Upadhyay, PhD, MPH, Professor and public health scientist at University of California, San Francisco discussed the implications on health care providers and patients and reiterated mifepristone’s safety: 

“While mifepristone currently remains available for medication abortion and miscarriage care, the drug’s approval is very much still in jeopardy, and in the midst of an already existing crisis for abortion access.

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And, the effects will be felt the most severely by those already suffering from the inequities in our healthcare system – Black people and other people of color, people living with low incomes and already struggling to make ends meet, LGBTQ+ people, young people – those people who can least afford another devastating blow to their health care. 

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This is yet another effort to interfere with the patient-provider relationship, making it harder for people to get the medical care they need and deserve. If this ruling stands, it will create harmful reverberations, affecting patients, healthcare providers, and the pharmaceutical industry, all of whom rely on the expertise of FDA to make scientific determinations regarding the safety and effectiveness of our nation’s medications.”

Josh Sharfstein, Former Principal Deputy Commissioner of the FDA, spoke to the unprecedented nature of the decision and the larger FDA implications for other drug approvals: 

“These decisions are wrong. They are shocking. And they are dangerous. There is not a credible, scientific argument or dispute about the safety of this medication.
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It is so clearly coming from an ideological opposition to abortion. It’s as if the judge decided to do it because the judge could…” 

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It throws open the fundamental foundation of drug regulation… In my experience over 20 years, I have never seen the unanimity of the patient advocacy community, from the pharmaceutical companies that are developing new treatments to the general population that cares about the FDA’s function, in being absolutely shocked at the potential major step back in the United States in health as a result of undermining the role of this critical agency.”

Eva Temkin, Former FDA Attorney provided the pharmaceutical industry’s perspective: 

“The lower courts in this case second-guessed FDA’s scientific judgment regarding drug approvals and substituted their own judgment  – based on anecdotes and unreliable, cherry-picked publications. Left unchecked, the lower court’s non-expert judicial second-guessing of FDA’s scientific judgment can really cause turmoil for the industry, those who invest in it, and most importantly, the patients who depend on it.
If allowed to take effect, the lower court’s decisions will result in a seismic shift in the clinical development and drug approval processes. They will erect unnecessary and unscientific barriers to the approval of lifesaving medicines, chill crucial research, drug development and investment – all of which will irreparably harm patients.” 

Legal and advocacy groups, American Civil Liberties Union, Planned Parenthood Federation of America, and NARAL Pro-Choice America have experts ready to comment on the impacts of the case as it stands before the Supreme Court. If interested in speaking with anyone, please do not hesitate to reach out to [email protected]. 

A recording of the press call can be found here. 

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