The US Food and Drug Administration will overview proof about the safety and efficacy of mifepristone, one of the medicine utilized in remedy abortion, to analyze how it may be safely distributed, US Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary wrote in a new letter to 22 Republican attorneys normal.
Kennedy and Makary stated the FDA would conduct “its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.”
“This Administration will ensure that women’s health is properly protected by thoroughly investigating the circumstances under which mifepristone can be safely dispensed,” they wrote within the letter, despatched September 19.
The letter is driving concern amongst abortion advocates that the federal authorities could put new limits on access to remedy abortion, which has been extra broadly out there via telehealth in recent times.
Kennedy already informed senators earlier this month that the FDA is accumulating new information in a safety overview of mifepristone and stated “those studies are progressing and that they’re ongoing.” Kennedy claimed within the listening to that the Biden administration “twisted the data” on mifepristone to “bury one of the safety signals,” however didn’t present extra particulars about what the safety subject may very well be.
“We’re getting data in all the time — new data that we’re reviewing,” Kennedy informed the US Senate Committee on Finance.
Mifepristone is often used together with one other drug, misoprostol, for remedy abortion within the United States. The FDA permitted mifepristone in 2000, and it has lengthy been proven to be protected and efficient. It is cleared to finish a being pregnant via 10 weeks of gestation.
Clinical research and many years of use have established the drug’s safety and effectiveness. Since its approval within the US in 2000, there have been 5 deaths related to mifepristone for each 1 million individuals who used it, based on the FDA. That means the loss of life charge is 0.0005%. Mifepristone’s safety is on par with these of frequent over-the-counter ache relievers like ibuprofen and acetaminophen, research present.
Major medical teams, together with the American College of Obstetricians and Gynecologists, have repeatedly known as for extra mifepristone accessibility. During the Covid-19 pandemic, the Biden administration started permitting licensed suppliers to prescribe the drug by way of telehealth and ship it by mail, which considerably expanded access, significantly in rural areas with few abortion clinics.
But anti-abortion advocates have claimed that the drug isn’t protected and that the FDA didn’t examine it sufficient to make sure its safety. Republican officers have repeatedly known as for the federal government to rescind the telemedicine coverage for mifepristone and prohibit distribution to in-person visits solely. The US Supreme Court declined in June 2024 to dam the drug’s availability however left the door open for future regulatory modifications, inserting the highlight again on federal agencies just like the FDA.
In 2024, there have been greater than 1 million abortions within the US for the second yr in a row, based on the Guttmacher Institute, a analysis and coverage group targeted on sexual and reproductive well being that helps abortion rights.
Since the US Supreme Court’s Dobbs choice revoked the federal proper to abortion in June 2022, 20 states have enacted bans or severely restricted access, and a few have applied new protections for abortion care. Expanded access to clinics that present remedy abortion via telehealth has contributed to the rise in abortions within the US, based on Guttmacher: About 14% of abortions in 2024 have been supplied by online-only clinics, up from 10% in 2023 – or a rise of about 40,000 abortions.