Food and Drug Administration Approves Generic Version of Mifepristone

What Happened?

This week. the U.S. Food and Drug Administration (FDA) approved a generic version of mifepristone, a drug that has many uses, including chemical abortion. Anti-abortion activists criticized the move by the FDA, but Andrew Nixon, a spokesman for the Department of Health and Human Services (HHS) said, ‘The FDA has very limited discretion in deciding whether to approve a generic drug.’

According to federal law, HHS must approve an application if it demonstrates that the generic drug is identical to the brand-name drug, as it was in this case. 

Why it Matters

When the Supreme Court overturned Roe versus Wade, which had upheld the legal right of women to seek abortion, the new ruling left it up to the states to decide whether to legalize the practice of abortion. Currently, twenty-one states plus the District of Columbia have legalized abortion, with the remainder placing a ban on abortion, though the conditions under which it can still be done in banned states vary widely.

Since the Supreme Court overturned Roe versus Wade, abortions in the United States have not declined. One reason is that women seeking abortion have turned in greater numbers to medical abortion instead of going to a clinic or hospital. Medical abortion refers to the taking of medication that causes the fetus to abort, and one of those medications is mifepristone. 

Despite critics labeling mifepristone as an abortion drug, it has several non-abortion clinical uses. For example, mifepristone can be used to treat Cushing’s syndrome. Cushing’s is caused by high cortisol levels, and mifepristone is a cortisol blocker. Mifepristone can also be used to treat endometriosis and uterine fibroids, the latter of which are non-cancerous tumors in the uterus. 

When taken in tandem with misoprostol, mifepristone can also be used to cause chemical abortion in early pregnancies, typically within the first ten weeks. The switch from clinical to chemical abortion has proved vexing for anti-abortion activists because medication can be shipped across state lines. Women in any state, even where abortions are banned, can receive medication through the mail.

There have been court challenges to the use of medication for abortion. Most prominently, Texas and New York have sued each other over mifepristone use, which is legal in New York but banned in Texas. The case has gone to the Supreme Court, but no final ruling on the case has yet been issued. The outcome of the case may not be determined until 2026 but will likely play a significant role in shaping future use of mifepristone for abortions. 

How it Affects You

Because mifepristone has multiple uses, banning it would also affect people who were not seeking abortions. For that reason, it is a particularly thorny issue for the courts. While the legal battles continue in court, the approval of a generic version of mifepristone will probably lead to increased use of the medication because generics tend to be cheaper than brand-name drugs.