Introduction to the FDA Approval of Generic Abortion Pill
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.
Background on Mifepristone Approval
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. 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.
Reaction to the Approval
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.” 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.
FDA Review and Approval Process
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. 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 to Abortion Care
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. 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 Support and Restrictions
Restrictions on the pill are not supported by most major medical societies, including the American Medical Association. On its website, Evita states that it “believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care.” The company did not immediately respond to requests for comment.
Conclusion
The approval of another generic version of the abortion pill mifepristone has sparked controversy and debate. While the FDA has deemed the drug safe and effective, abortion opponents continue to push for restrictions on its use. The issue remains a highly contested and complex one, with ongoing lawsuits and shifting state laws impacting access to abortion care.
FAQs
Q: What is mifepristone and how does it work?
A: Mifepristone is a medication that dilates the cervix and blocks the hormone progesterone, used in combination with misoprostol to end pregnancies through 10 weeks.
Q: What is the significance of the FDA approving another generic version of mifepristone?
A: The approval is a regulatory formality that has sparked controversy and debate, with abortion opponents pushing for restrictions on the drug’s use.
Q: How does the approval affect access to abortion care?
A: The approval of a second generic is unlikely to affect access to the pill, which is already widely used but restricted in some states due to laws banning abortion or imposing separate restrictions on the drug’s use.
Q: What is the stance of major medical societies on restrictions to mifepristone?
A: Restrictions on the pill are not supported by most major medical societies, including the American Medical Association.
