Jeffrey A. Singer
At the beginning of this month, the Food and Drug Administration approved a second generic version of the abortion pill mifepristone. The agency first approved the drug in 2000 and a generic version in 2019. The drug, used to terminate pregnancies up to the tenth week of gestation, has proven to be safe and effective. Regardless of one’s personal views on abortion, the FDA’s handling of this drug illustrates how the agency’s monopoly over drug approval can limit access to medications that are already proven safe and effective.
Anti-abortion lawmakers and activists are very upset about the FDA decision, with former Vice President Mike Pence calling it a “complete betrayal of the pro-life movement that elected President Trump.” He called for Health and Human Services Secretary Robert F. Kennedy, Jr., to resign. And Senator Josh Hawley (R‑MO) exclaimed he no longer had confidence in FDA leadership.
An FDA spokesperson stated that the agency’s hands were tied: it is legally required to approve a generic version of a drug, if it is identical to the brand-name drug. However, responding to political pressure, HHS Secretary Kennedy posted on X on October 2, 2025, that he is ordering a review of the drug’s safety, citing his concern that it might be unsafe for patients to consume mifepristone “without proper medical supervision.”
Reopening a safety review for this drug appears to be driven by political rather than scientific reasons. This is not about the procedure itself but about the principle that safe, approved drugs should not be subject to political interference.
Kennedy’s decision perfectly illustrates how the agency’s work can be swayed by political or moral pressure rather than evidence. As I explained in Your Body, Your Health Care, the FDA’s very structure enables this kind of paternalism: “So long as Congress allows the FDA to act as a paternalistic gatekeeper between consumers and drugs, the agency will err on the side of delaying and denying consumers access to new products and new information.” And even under the most ethical and conscientious management, agency heads will remain vulnerable to political and special interest pressure.
That’s why it took until 2023 before the FDA finally removed barriers to over-the-counter access to the nasal spray version of the overdose antidote naloxone (the FDA still requires adults to get a permission slip—aka a prescription—from a government-licensed clinician to obtain the cheaper injectable form), while people in Italy had access to the drug since 1996 and Australians had access since 2016.
It’s why women in more than 100 countries can obtain birth control pills over-the-counter, but the FDA blocks over-the-counter access to all forms of birth control pills except for one brand of one type of pill. It’s why it took 14 years and a court order for the government to unblock over-the-counter access to the emergency contraceptive Plan B.
The ability to make personal medical choices lies at the heart of medical ethics—particularly when those choices can determine life or death. When political considerations impose restrictions, including mandatory prescription rules, they undermine that fundamental right and, in doing so, jeopardize people’s health and, sometimes, their lives. It remains to be seen whether political considerations will cause the FDA to change its stance on mifepristone and restrict women’s access to the drug.
Most people find it hard to picture a world without the FDA’s exclusive control over drug approvals. But demand for reliable information on a drug’s safety and effectiveness would still exist. The mifepristone controversy reinforces the case for opening that market to competition by ending the FDA’s monopoly. These reforms would foster innovation, respect autonomy, and ultimately serve the public’s interests.
Until we end the FDA’s monopoly on medical decision-making, patients will continue to pay the price for politics masquerading as protection.