But it left other unnecessary restrictions in place, reminding us that abortion care is treated differently.
By Daniel Grossman
Dec 20, 2021
It took a pandemic, a lawsuit and an eight-month review of the evidence, but the Food and Drug Administration has finally loosened some of the restrictions it imposed 21 years ago on mifepristone, which is used together with a second medication, misoprostol, for medication abortion. While the FDA could have gone further, this move is based on solid scientific evidence and will improve access to abortion care for at least some people.
At issue was the FDA’s risk evaluation and mitigation strategy, or REMS, an extra layer of regulatory scrutiny that the agency applies to a small number of drugs that have safety concerns. Given decades-long experience with mifepristone and documenting the safety of the medication, physicians and researchers have been urging the FDA for years to remove mifepristone’s REMS. Not only was there no clear rationale about how the restrictions on mifepristone improved the drug’s safety, but there are many medications, including Viagra, with more significant risks without a REMS.
Continued: ttps://www.washingtonpost.com/outlook/2021/12/20/telemedicine-abortion-fda-safe/