Abortion Derangement Syndrome
Abortion is an urgent American healthcare issue – but it is not the only one. Witness the current red-hot debate over the drug mifepristone (aka “the Abortion Pill”), the latest battle in the war of hyperbole versus science. Should the side that screams the loudest win? Alas, the extremes of both sides are acting as though the answer is “yes.” They’re wrong and it’s dangerous.
When U.S. District Judge Matthew Kacsmaryk ruled Texas could unilaterally decide to outlaw the sale of mifepristone, an FDA-approved product, the story leapt to the top of the national news cycle. After all, what’s more important than the next battle in our post Roe v. Wade society? Cry “Havoc,” and let slip the dogs of war. But, when it comes to healthcare policy, should the ends justify the means?
What really happened is that we unleashed a deluge of fake news. According to some on the pro-choice side, mifepristone is “safer than aspirin.” This is not only abysmally incorrect, but also embarrassingly so. On the pro-life side, we’re told that the drug was hastily approved by the FDA. Nope. Mifepristone was approved in 2000 following a 54-month review period. To put that in perspective, during that same time frame, the median time for a drug review was 15.6 months. This is particularly germane since the lack of appropriate regulatory deliberation was one the foundational points used by Judge Kacsmaryk in his decision. As the saying goes, we live in the era of smart phones and stupid people.
Abortion, however, is not the most important issue at play. If the U.S. Supreme Court allows the Texas ruling to stand (which I believe it will not), healthcare innovation would cease, and confusion reign throughout the land. If a state can ban an FDA-approved product, another state could allow a drug on the market that has been denied a license by the FDA. Not only would patients and healthcare providers lose faith in the drug approval process (arcane, nuanced, and complicated as it is), but snake oil salesmen would fill the void with quack cures for everything from cancer to Covid. The defenestration of FDA regulatory predictability would greatly diminish the desire to invest in healthcare technology innovation – and eradicate it almost entirely for riskier, cutting-edge products for conditions such as ALS, Alzheimer’s Disease, Friedreich ataxia, and Duchenne muscular dystrophy – diseases for which the FDA has recently approved pioneering therapies via advanced (and controversial) 21st century regulatory science.
Should we sacrifice future healthcare innovation on the white-hot altar of the abortion debate? Should decisions on new drugs and medical devices be booted down to the state level? Should inconvenient facts be set aside for the greater good? We’re already seeing the chaos caused by a lack of firm FDA oversight on less urgent issues such as marijuana, cannabidiol (CBD), and e-cigarettes. It’s a slippery slope – and a hard rain’s gonna fall. If we learn nothing else from our recent pandemic experience it’s that when emotion, religion, and politics supersede science and broader predictable negative consequences, people get confused and their immediate reaction is to lose faith in the government organizations that are tasked to do the right thing. Is the juice worth the squeeze?
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Scholar at the NYU School of Medicine, Division of Medical Ethics.
