'Experts – not judges – are best equipped to determine' drug safety

PART V: Mifepristone lawsuit

Jan 30, 2024

🔆 This is Part V of an ongoing multi-part series examining the mifepristone lawsuit to be heard by the Supreme Court of the United States. Read the rest of the series here.

For nearly one hundred years, “federal law has recognized the [U.S. Food and Drug Administration] as the government decision-maker on whether medicines are safe and effective.” [1] Over the course of those many decades, “the FDA has ensured the safety of drugs and treatments in the United States. The FDA’s processes for assessing a drug’s or treatment’s benefits and risks are rigorous, involving extensive lab and clinic testing. The results are reviewed by experts in science and medicine before a drug or treatment is approved.” [2] Thanks to the FDA’s rigorous process, the “United States has the world’s most stringent standards for approving drugs, and drug approval standards are considered the benchmark by many regulators worldwide.” [3]

“The case, the Alliance for Hippocratic Medicine v. FDA, is disguised as a dispute over safety. In reality, it’s about whether the courts will go along with overturning, for political reasons, the authority of the FDA as the scientific arbiter of approval of new drugs and restrictions on their distribution.” [4] Already, “it is deeply troubling” that two lower courts involved in this case “have seen fit to undermine a settled agency approval on scientific grounds, substituting the courts’ nonexpert judgment for the FDA’s expert analysis,” especially in the case of a drug, mifepristone, whose FDA approval “has been established for so many years” — over 23 years, to be exact. [5] Now before the Supreme Court of the United States (SCOTUS), this case could ultimately “call into question the FDA's power to regulate all drugs nationwide,” [6] and “effectively end the FDA's status as the ultimate arbiter on drug safety.” [7] According to Susan Lee, a partner in Goodwin Law’s Life Sciences group and FDA practice, "This case potentially has very significant consequences for both products that are already on the market, as well as new products.” [8] "The potential implications are so much broader than just what could happen to mifepristone.” [9]

Judges are not experts in pharmaceuticals, the practice of medicine, patient health, or science. “Judges lack the scientific knowledge and understanding to determine whether a medicine is safe and effective, including whether and in what form distribution restrictions are needed.” [10] It is not only inappropriate, from a scientific standpoint, for judges to intervene in medication evaluations, approvals, and regulations, but “it also poses a serious threat to medical innovation.” [11] The potential consequences go “far beyond the fraught area of reproductive health, throwing the regulatory regime for medicines into disarray and potentially upending the business of drug making.” [12] “The entire biotechnology and pharmaceutical industry will be thrown into turmoil if judges can second-guess the scientific expertise of the US Food and Drug Administration.” [13]

A Supreme Court ruling against the FDA’s “approval of a drug over [23] years earlier would be unprecedented and could ripple through drug research and development for years, with implications for public health and access to new treatments.” [14] According to Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation, such a ruling “would call into question the entire drug approval process.” [15] "That would have much bigger implications for other drugs and probably would shake up pharma's ability to rely on the FDA and feel secure when they submit something, if a court can overrule the FDA's findings on safety," Sobel said. [16] This would likely lead “to self-censure by the pharmaceutical industry as drugmakers embrace treatments perceived as safe investments and shy away from those that might get caught up in politically charged legal entanglements.” [17] Furthermore, experts have warned, the possibility of the FDA’s “approvals being overruled would likely see the FDA become more cautious… The increased scrutiny would make it more difficult and time-consuming to get products approved, and possibly more expensive to develop.” [18]

“Retrospectively overturning F.D.A. decisions that are based on years of testing” would “destabilize the industry” by leading to political - not scientific - determinations of “what a medicine is and isn’t.” [19] Such a precedent would be “deeply harmful for vaccines, Alzheimer’s drugs, all the others.” [20]

Additionally, a “ruling against the FDA is likely to spur increased activism and lobbying from organizations opposed to other drugs or medical treatments, such as COVID-19 vaccines, contraceptives, hormones for artificial reproductive technology or gender affirming procedures, and HIV prevention drugs.” [21] According to STAT, which covers health and medicine, “Leaving scientific approval decisions to judges would needlessly weaken the long-standing FDA approval framework. And it would do so in a way that allows — and propels — politically motivated plaintiffs to challenge the scientific conclusions of the FDA. This could destabilize the life sciences industry, undermine investment, and ultimately put patients’ health at risk.” [22] A decision by the United States Supreme Court that overrules the FDA’s authority and restricts mifepristone “risks emboldening other courts to block access to FDA-approved drugs and treatments for reasons having nothing to do with their safety or efficacy.” [23] Challenges similar to the mifepristone case, brought before hand-picked, sympathetic judges, “could lead to other reversed approvals.” [24]

For anti-abortion zealots and other extremists, there is no shortage of drugs to attack for political and ideological ends. Hormonal contraception and intrauterine devices (IUDs) for the prevention of pregnancy are already a target of the anti-choice movement. Hormone therapy, used to “treat cancers, including breast cancer,” used in fertility treatments, and used to treat other conditions, could be targeted by anti-LGBTQ+ extremists because hormone therapy is a part of Gender Affirming Care (GAC). [25] Radical legislators in multiple states have already demonstrated an enthusiasm for targeting LGBTQ+ Americans. And what about vaccines and medications developed using fetal stem cells? Anti-choice zealots already target these drugs. [26] [27] [28]

“[E]xperts – not judges – are best equipped to determine the safety and efficacy of drugs and treatments.” [29] Should the Supreme Court usurp FDA authority in the mifepristone case, “patients may no longer have the security of knowing that determinations about drug safety ultimately lie with the experts,” [30] and will be left to wonder, “Will my medication be next?”

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