What promise to 'review the data' could mean for health
By Lisa Jarvis / Bloomberg Opinion
Anyone listening to Thursday’s confirmation hearing for Marty Makary, President Trump’s pick to lead the Food and Drug Administration, should have heard alarms go off during discussion of a topic affecting access to health care for millions of Americans: his approach to regulation of the abortion pill mifepristone.
Makary mostly sidestepped direct answers to senators’ questions. But he sounded prepared to relitigate more than two decades of safety data on the drug, which is part of a two-pill regimen of medication abortion that has been approved since 2000.
He repeatedly told senators he would “review the data” on mifepristone. However, that review will determine women’s access to the drug, and Makary’s answers made it apparent that he’s more likely to follow Trump and the political winds on abortion and other critical areas he would oversee at the FDA, including vaccine regulation.
When the Supreme Court overturned Roe v. Wade in 2022, allowing state abortion bans to proliferate, mifepristone became the epicenter of the fight over reproductive rights. Part of Makary’s role as FDA commissioner is deciding how the pill can be prescribed and dispensed. For two decades, FDA guidelines required that it be dispensed in person; by a doctor. In 2021, regulations were loosened to allow it to be prescribed via telehealth and sent by mail-order delivery or pharmacy pick-up. Pharmacies must be specially registered to dispense the medication, and the FDA has maintained a program that requires monitoring its safety.
https://www.heraldnet.com/opinion/comment-what-promise-to-review-the-data-could-mean-for-health/