At The Regulatory Review, Evelyn Tsisin L’24, GR’24 argues that the FDA — not courts — should decide on the safety of abortion drugs.
Evelyn Tsisin L’24, GR’24 recently argued that the “FDA, Not a Federal Judge, Should Decide on Abortion Drugs,” in a piece published at The Regulatory Review.
In the article, Tsisin analyzes the arguments presented by the Alliance for Hippocratic Medicine (AHM) in support of its claim that the FDA’s approval of the medical abortion drug mifepristone lacks authority, harms women and their doctors, and must be withdrawn. She concludes that “FDA’s decisions, rooted in scientific and medical principles, supported by years of clinical data and experience, certified by Congress’s watchdog, and trusted by health care professionals and the women they serve throughout the nation, should not be second-guessed and overridden by a single judge, in a single state.”
From The Regulatory Review:
The U.S. Food and Drug Administration (FDA) should have the final say on what drugs are safe and effective for use in their prescribed populations—not states, not courts, and certainly not the Alliance for Hippocratic Medicine (AHM).
The organization, a consortium of medical advocacy groups gathered to challenge FDA, filed its final brief in a Alliance for Hippocratic Medicine v. FDA in a federal trial court in Texas earlier this week. The group argues that the FDA’s approval of the medical abortion drug mifepristone lacks authority, harms women and their doctors, and must be withdrawn.
This case is one of many to come in the aftermath of the Dobbs v Jackson Women’s Health decision, which gave states the power to regulate any aspect of abortion not regulated by federal law.
If AHM prevails, mifepristone, one of two drugs that taken together account for over half of U.S. abortions, may be pulled from the market. With millions of women relying on the dual drug regimen for abortion access in the post-Dobbs world, such a misguided decision would cause short-term chaos and set a dangerous long-term precedent… .
The Regulatory Review is a daily online publication that provides accessible coverage of regulatory policymaking and enforcement issues across a full range of regulatory topics and from a variety of perspectives.
Launched in 2009 and operating under the guidance of Cary Coglianese, Edward B. Shils Professor of Law and Professor of Political Science, The Review is edited by students at Penn Carey Law. It is part of the overarching teaching, research, and outreach mission of the Penn Program on Regulation (PPR), which draws together more than 60 faculty from across the University of Pennsylvania.