&imwidth=800&imheight=600&format=webp&quality=medium "'Not an endorsement': Trump admin attempts damage control after facing backlash for FDA's approval of generic abortion pills")
After facing backlash due to the authorisation of generic form of mifepristone by US Food and Drug Administration (FDA)The White House on Friday (Oct 3) defended FDA's decision. In a statement, it clarified that the authorisation of abortion pill mifepristone should not be seen as an endorsement of the drug. This comes after the Trump administartion faced massive backlash specially from its anti-abortion supporters over FDA's sudden approval. The approval was made quietly just before a US government shutdown. Essentially, the approval means that now the total number of US companies producing mifepristone goes up to three.
Addressing a press conference, White House Press Secretary Karoline Leavitt said that the FDA was legally obligated to approve the generic version if it met requirements proving it was equivalent to the brand-name drug. She stated, "It’s not an endorsement of this drug by any means. They are just simply following the law…By law, the Secretary of the Department of Health and Human Services must approve a generic drug application if the application demonstrates the drug is the ‘same’ as the brand-name drug.”
The sudden decision came as a surprise for anti-abortion advocates as it followed Health Secretary Robert F Kennedy Jr's recent announcement that a comprehensive safety review of mifepristone will be set up. This has raised expectations that stricter controls might follow but the latest move by FDA proved otherwise.
Mifepristone already has generic versions on the market since its initial approval in 2000. As per original risk evaluation and mitigation strategy program from 2011, mifepristone was required to be dispensed in person by a doctor or under the supervision of a physician at a hospital or clinic. Revisions in 2021 and 2023 expanded the window of use from up to 7 weeks to up to 10 weeks of pregnancy.
