FDA Approval of Generic Abortion Pill
Introduction to the Controversy
Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with the Trump administration.
Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form of the pill, which is approved to end pregnancies through 10 weeks.
Reaction from Anti-Abortion Groups
Criticism and Outrage
Students for Life Action, which opposes abortion, in a statement Thursday called the approval “a stain on the Trump presidency and another sign that the deep state at the FDA must go.”
Republican Sen. Josh Hawley of Missouri also criticized the move in a post on X, stating: “I have lost confidence in the leadership at FDA.”
Background on Mifepristone
History and Safety
The criticism comes as Republican President Donald Trump’s top health officials, including Health Secretary Robert F. Kennedy Jr., face growing pressure from abortion opponents to reevaluate mifepristone, which was approved 25 years ago and has repeatedly been deemed safe and effective by FDA scientists.
In a letter to Republican attorneys general last month, Kennedy and FDA Commissioner Dr. Marty Makary pledged to conduct a full review of the drug’s safety.
FDA Approval Process
The FDA approved the original version of mifepristone in 2000 and gradually eased access over time. That included approving the first generic pill, from drugmaker GenBioPro, in 2019.
In 2021, the FDA under Democratic President Joe Biden permitted online prescribing and mail-order delivery of the drug, greatly expanding access. Abortion opponents have been fighting the change ever since.
Generic Drug Approval
Process and Timeline
Approval of generic drugs is typically a rote process at the FDA, with multiple copycat versions usually approved after the patent on the original drug expires. In most cases, generic drugmakers only need to show that their drug matches the ingredients and formula developed by the original drugmaker.
The FDA typically approves such applications within 10 months. But filing documents posted to the FDA’s website show that Evita Solutions filed its application to market mifepristone four years ago.
Impact on Access
Limited Effect Due to State Laws
Approval of a second generic is unlikely to affect access to the pill, which is typically taken with another drug, misoprostol. The combination accounts for roughly two-thirds of all U.S. abortions. Mifepristone dilates the cervix and blocks the hormone progesterone, while misoprostol causes the uterus to cramp and contract.
Access to mifepristone is restricted across large sections of the country because of state laws that ban abortion — including medication abortion — or impose separate restrictions on the drug’s use. Those laws are subject to a number of ongoing lawsuits that are winding their way through the legal system.
Medical Community Perspective
Support for Access
Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.
Conclusion
The approval of another generic version of the abortion pill mifepristone has sparked controversy and outrage among anti-abortion groups and politicians. Despite the criticism, the FDA has deemed mifepristone safe and effective, and its approval is a significant development in the ongoing debate over access to abortion.
FAQs
Frequently Asked Questions
- Q: What is mifepristone?
A: Mifepristone is a medication used to end pregnancies through 10 weeks. - Q: How does mifepristone work?
A: Mifepristone dilates the cervix and blocks the hormone progesterone, while misoprostol, taken in combination, causes the uterus to cramp and contract. - Q: Is mifepristone safe?
A: Yes, mifepristone has been repeatedly deemed safe and effective by FDA scientists. - Q: What is the impact of state laws on access to mifepristone?
A: State laws that ban abortion or restrict the use of mifepristone limit access to the medication across large sections of the country.
