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Jill Wechsler is Pharmaceutical Technology's Washington Editor, firstname.lastname@example.org.
FDA is halting enforcement of a policy that limits prescribing and dispensing of Mifeprex (mifepristone), a widely used drug to induce a medical abortion in the very early stages of pregnancy. The revision allows doctors to authorize the pills via telemedicine and to make them available to patients through mail-order pharmacies while the pandemic continues, as a way to facilitate treatment while minimizing risky personal contact. And it puts FDA in the middle of the abortion debate.
Since approving Mifeprex for market in 2000, FDA has required women to obtain the drug directly from certified healthcare providers in certain clinics, medical offices, and hospitals. The shared risk evaluation and mitigation strategy (REMS) program for the drug and generic equivalents calls for patients to be evaluated by trained medical professionals and blocked product dispending by retail or mail-order pharmacies or over the Internet. While medical professionals and women’s health advocates have opposed these restrictions for years, the limitations appeared more egregious when the Trump administration dropped similar distribution restrictions for a number of high-risk medicines to ease patient access to treatment during the pandemic, but did not extend such flexibility to mifepristone, despite its strong record for being safe and effective.
Now FDA is modifying the requirement for in-person consultation, stating that the agency will exercise “enforcement discretion” regarding dispensing limitations during the public health emergency and will be flexible in permitting Mifepristone dispensing through the mail . FDA Acting Commissioner Janet Woodcock confirmed the change in letters to the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine.
FDA’s move was praised by ACOG leaders, who sought and gained federal court approval in July 2020 for FDA to suspend its restriction on mifepristone dispensing directly to the patient in a clinic or medical office. The judge cancelled the prescribing restrictions on the basis that requiring women to travel to clinics in person to obtain the pill put them at risk of COVID infection. However, the Trump administration appealed the ruling, and the Supreme Court overrode that decision in January 2021, restoring the requirement that individuals seeking medication abortions must obtain the pills in person.
Now FDA has moderated the in-person prescribing requirement, supported by evidence from continued review of adverse events related to Mifeprex during the six months last year when the more liberal dispensing policy was in effect. Woodcock explained in her letter that FDA reviewed studies related to mifepristone safety and adverse event reports from January 2020 to January 2021 and found no evidence that remote patient consults raised serious safety issues, such as sepsis infection, bleeding, or ectopic pregnancy.
The debate reflects how Mifeprex has become more widely used to halt unwanted pregnancies as state and federal policies have made surgical abortions more difficult to obtain. Abortion opponents seeking to limit access to mifepristone claim that a telemedicine appointment to discuss such treatment raises grave safety risks to patients. Several states are considering bills to ban the pills or make them even harder to obtain. However, state restrictions could become moot with more flexible video consultation policies that enable patients to obtain a prescription from a physician in another state and to receive the drug through the mail. Some women may be reluctant to take a pill that is banned in their home state for fear of arrest and charges, even though most doctors consider mifepristone safer than many common over-the-counter pain medications.
FDA announced its more flexible approach to Mifeprex prescribing as a deadline neared for a federal appeals court to decide a challenge to the Trump requirements upheld by the Supreme Court. A long list of leading medical societies, including the American Medical Association, the American Academy of Family Physicians, and ACOG, sent a letter March 1, 2021 to President Biden and Vice President Harris urging “swift action” to end the prior administration’s “unscientific and discriminatory policy” that forces patients prescribed mifepristone for pregnancy termination to pick up their medications at a health center. They point out that such requirements contradict actions by FDA and other federal agencies to promote the use of telemedicine during the pandemic to ensure access to health care while limiting unnecessary contact.
Separately, the Biden administration has moved to repeal regulations instituted by the Trump administration that bar family planning clinics that receive federal funds from offering abortion referrals and counseling. That move was widely hailed by women’s health advocates, but strongly opposed by anti-abortion forces.