The abortion pill, Mifeprex, has been one of FDA’s most restricted drugs.
Editor’s note: A Newsy investigation looks at why the Food and Drug Administration has made Mifeprex, also known as the “abortion pill,” one of the most restricted drugs. Despite having a better safety record than penicillin or Viagra, it’s more restricted than opioids like fentanyl. Newsy reporters explore how the restrictions affect access for some patients in medically underserved communities.
“With the horrible horrible experience I had giving birth to my daughter, I mean I couldn't even mentally handle, like going through a cervical check,” S recalled. “So I wanted to do a medical if at all possible.” So many women like S have to navigate FDA regulations imposed on Mifeprex and the ever-changing landscape of state abortion laws that target medication abortion. This can often be a source of anxiety because medication abortions are only available in the first 10 weeks of a pregnancy.
In 2000, the FDA approved Mifeprex but it could not be sold at pharmacies with a prescription because the agency wanted to monitor its safety.A database called the FDA Adverse Events Reporting System, or FAERS, tracks side effects, complications and even deaths after a person takes a drug. While some opponents of medication abortion say Mifeprex is dangerous and kills people, FDA data shows there is no direct link between taking the pill and the deaths. Nearly half of the recorded deaths appear to be related to homicide, drug abuse, suicide and emphysema.
“I would love to see the FDA actually do its job in monitoring the safety of this drug,” Harrison said. “I think the FDA has been deficient in its oversight of this drug post marketing.” “Exactly, what is more dangerous about picking a pill up in a pharmacy than having somebody giving it to you in a clinic and you take it home and you swallow it?” asked Winikoff.
FDA officials declined to speak to Newsy on camera. But, when asked why the drug still isn’t available at pharmacies, an agency spokesperson wrote in an email, “Certain restrictions continue to be necessary to ensure the safe use of the drug.” “Unfortunately, because of the restrictions I don't provide medication abortions in my practice,” said Dr. Graham Chelius, a family physician. “I work for a health care system. And so I just can't say, you know, we're just going to stock this medicine.”
Because the REMS program is controlled by the FDA it doesn’t matter if you live in a state like Hawaii, with no state abortion restrictions.
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