ICYMI: Alliance for Hippocratic Medicine v. FDA threatens the FDA’s Gold Standard Approval Process

Washington, D.C. – The pending case, Alliance for Hippocratic Medicine v. FDA — which threatens to effectively place a nationwide ban on mifepristone, a crucial medication for abortion and miscarriage care — could also have broader implications for the Food and Drug Administration’s drug approval process. If Judge Matthew Kacsmaryk orders withdrawal of approval of mifepristone, the decision could upend the agency’s authority by setting a precedent for courts to overturn the FDA’s approval of other medications for political reasons, including essential medications such as hormone blockers or vaccines.

Over the weekend, POLITICO Prescription Pulse noted the potential long term fallout resulting from the case: 

• “...If Kacsmaryk sides with the plaintiffs, some legal experts fear it could set a precedent for courts to overturn the agency’s approval of other drugs the FDA has approved. ‘You could have scientific decisions overturned by nonscientists,’ said a former senior FDA official, who was granted anonymity due to concern about their physical safety. ‘That undermines the value of the agency and the professional staff...’” 

In its coverage, The Washington Post highlighted the potential for future lawsuits over other FDA approved medications if Judge Kacsmaryk chooses to side with the plaintiffs:

• “...Critics say the legal theories in the lawsuit are specious, but they acknowledge that Kacsmaryk’s ruling could sow confusion over FDA regulations, weakening an agency at a time when scientific and medical expertise are under attack, possibly inviting lawsuits over any number of previously approved medications…” 
• “Drugmakers are also eyeing a decision closely. The FDA has an onerous process for taking a drug off the market. Some legal experts also say an adverse ruling against the FDA could spook pharmaceutical companies that invest millions in researching and developing drugs with the assurance there’s a high bar to remove a drug from the market once it has been approved.”
• “‘The FDA is the gold standard for determining whether a medicine is safe and effective for people to use,’ Priscilla VanderVeer, a vice president at Pharmaceutical Research and Manufacturers of America, the major drug lobby, said in a statement. ‘While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines.’”

Similarly, STAT News addressed concern that others in the medical industry have with a ruling that could affect approval of other medications: 

• “...Others in the industry expressed worry about Covid-19 medications, weight loss medications, HIV medications, sickle cell medications — any class of medicines that might be politically unpopular for one reason or another.”
• “‘If this injunction is issued, it will have an enormous consequence on the provision of critical care to women,’ said Jeremy Levin, CEO of Ovid Therapeutics, warning that restricting this kind of care would threaten patients’ lives. He also called it ‘a potential dagger at the heart of our industry.’ As he explained, ‘Here, you’re not just challenging the right for a woman to treat a pregnancy or to treat miscarriage; you’re also now challenging the primacy of the FDA to approve vast, important medicines that are critical to our society’s health, and that has a fundamental impact on the entire nation.’”

The Financial Times noted the chaos that could ensue  if Judge Kacsmaryk tried to pull mifepristone off the market, harming the the FDA’s  well crafted review process: 

• “ …A ruling in favor of the anti-abortion groups would take ‘a legal sledgehammer’ to the independent system of medical and scientific appraisal of drugs established by the FDA, he added, in addition to creating regulatory ‘chaos’ and raising costs for industry.
• ‘The precedent would be deeply unsettling and raises the question . . . what could be next tomorrow? It opens the door for potential political or religious third parties to question and overturn the determinations of our nation’s drug regulatory and safety system,’ Levin said. ” 

Legal and advocacy groups, the American Civil Liberties Union, Planned Parenthood Federation of America, and NARAL Pro-Choice America have legal and political experts ready to comment on the potential impact of the case on the FDA and access to abortion nationwide. If interested in speaking with anyone, please do not hesitate to reach out to [email protected].  

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