The Food and Drug Administration silently approved a new generic form of the abortion pill mifepristone on Oct. 2. Drugmaker Evita Solutions publicized that the FDA signed off on its form of mifepristone, allowing the termination of pregnancies through 10 weeks. The original approval of Mifepristone was in 2000, and access to it has since become increasingly restricted.
This is the second generic version of the pill to be available aside from the previous product created by the pharmaceutical company GenBioPro. With this approval, multiple anti-abortion organizations and conservative political figures have expressed their concerns.
“Secretary Kennedy and FDA Commissioner Makary assured Congress and the American people they would conduct a thorough review given credible evidence of the harm inflicted by these drugs,” President of the anti-abortion group Susan B. Anthony Pro-Life America, Marjorie Dannenfelser, said. “The prompt completion of the review is made more urgent given this approval to flood the market with a cheap abortion drug.”
Chair of the Health, Education, Labor and Pensions Committee Sen. Bill Cassidy released a statement on the approval.
“I fully support President Trump’s Pro-Life, Pro-Family agenda, but the FDA approving one more tool to kill babies is a betrayal,” Cassidy said. “This is not what Commissioner Makary and Secretary Kennedy indicated they would do in their confirmation hearings.”
There are 51 Republican senators who have signed a letter to the FDA and the Health Department advising them to revoke their approval of the new abortion pill. The letter cites research conducted by the Ethics and Public Policy Center, a Washington D.C.-based think-tank, showing that women may experience adverse health issues following the consumption of Mifepristone. Additionally, senators asked for the suspension of distributing Mifepristone.
Health Secretary Robert F. Kennedy Jr. and FDA commissioner Dr. Marty Makary sent a letter to Republican attorneys general pledging to conduct a full review of the drug’s safety, less than two weeks after the FDA approval.
The Health and Human Services Department has expressed that the FDA does not endorse drug products and has very limited deciding powers whether to approve a drug.
“The FDA has very limited discretion in deciding whether to approve a generic drug. By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” HHS spokesperson Andrew Nixon said in a statement.
In most cases, the FDA issues press releases after any new or significant drug, but did not do so in this case. The drug is expected to be available and launched in January of next year.
