The FDA’s rule change expands the availability of abortion pills to many more pharmacies, including large chains and mail order companies.
WASHINGTON — The Food and Drug Administration on Tuesday completed a rule change that expands the availability of abortion pills to many more pharmacies, including large chains and mail-order companies.
The Biden administration partially implemented the change Last year it announced it would no longer enforce a long-standing requirement for women to pick up the drug in person. Tuesday’s promotion officially updates the drug’s labeling to allow many more retail pharmacies to dispense the pills as long as they complete a certification process.
The change could expand access to both physical stores and online pharmacies. Women can obtain and then receive a prescription via telemedicine consultation with a healthcare professional the pills by post to the extent permitted by law.
Still, the impact of the rule change was mitigated by numerous state laws restricting abortion in general and the pill in particular. Legal experts predict years of court battles over access to the pills as abortion rights advocates bring test cases to challenge government restrictions.
For more than 20 years, FDA designation limited distribution to a subset of specialty practices and clinics due to safety concerns. During the COVID-19 pandemic, the FDA has temporarily suspended the in-person requirement. The agency later said a new scientific review by agency staff supports facilitating access, agreeing with numerous medical societies that had long said the restriction was not necessary.
Two drugmakers that make branded and generic versions of abortion pills requested the latest FDA label update. Agency rules require a company to submit an application before changing drug dispensing restrictions.
Danco Laboratories, which sells the Mifeprex brand, said in a statement that the change “is critical to expanding access to medical abortion services and gives healthcare providers” another option for prescribing the drug.
The American College of Obstetricians and Gynecologists called the update an “important step forward.”
“While today’s FDA announcement will not solve access problems for every person who desires abortion treatment, it will provide additional opportunities for more patients who need mifepristone for medical abortion to secure this vital drug,” the group said in an explanation.
More than the half of US abortions are now performed with pills instead of surgery, according to the Guttmacher Institute, a research group that advocates for abortion rights.
The FDA approved mifepristone in 2000 to terminate pregnancies up to 10 weeks when used with a second drug, misoprostol. Mifepristone is first taken to dilate the cervix and block the hormone progesterone, which is needed to sustain pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue.
Bleeding is a common side effect, although serious complications are very rare. The FDA says more than 3.7 million US women have used mifepristone since it was approved.
Several safety requirements mandated by the FDA remain in effect, including training requirements to certify that prescribers can provide emergency care in the event of excessive bleeding. Pharmacies that dispense the pills also need certification.
https://www.kvue.com/article/news/nation-world/fda-finalizes-rule-expanding-availability-abortion-pills/507-583375b6-2fd6-4a16-969e-f6eb373de227 The FDA is expanding the availability of abortion pills