It could be dangerous to offer medication abortion to non-pregnant people and the FDA is concerned, an agency spokesperson told Politico.
Medication abortion is a regimen the FDA approved in 2000, and it is intended to induce an abortion within the first 10 weeks. It has also been caught in a storm of confusion among healthcare workers after the Supreme Court overturned Roe v. Wade in June.
"The FDA is concerned about the advance prescribing of mifepristone for this use," said the spokesperson, whom Politico granted anonymity to describe sensitive agency policies. "Mifepristone is not approved for advance provision of a medical abortion."
For the last few months, people who use the two drugs used in medication abortion, mifepristone and methotrexate, have reported issues regarding access at the pharmacy counter, and HHS recently launched an investigation over whether retail pharmacies can restrict access to the pills.
Some companies are selling abortion pills to people who are not pregnant; that includes one telehealth startup that operates in five states and sells the product for between $175 and $289.
After the landmark ruling, online requests for abortion pills from Aid Access — which offers non-pregnant people abortion pills — rose significantly in 30 states, according to a study published Nov. 1 in JAMA.
The spokesperson said allowing people to stock up on mifepristone could be hazardous because providers could not ensure safety and effectiveness of the drug's use. However, Choix CEO Cindy Adam, MSN, told Politico there should not be barriers or restrictions.
"Science has consistently shown that when people have accurate information and access to abortion pills, they can safely end a pregnancy in their own homes," Ms. Adam said. "Providing abortion care through advance provision should be no different."
Nineteen states require a physician to be present during the administration of medication abortion, meaning it is illegal in those states to obtain those pills through telemedicine. The FDA spokesperson declined to say whether the agency is considering altering its regulations to medication abortion. The agency cannot supersede those state laws, but it has the power to fine violators and impose injunctions, according to Politico.