During the 2022-2023 holiday season, the Biden administration has taken several meaningful measures to protect and promote access to reproductive health care. These actions, by the Food and Drug Administration (FDA), the Department of Health and Human Services, and the Department of Justice (DOJ), are important in expanding access to and combating attacks on abortion and contraception.
The FDA taken action on Plan B emergency contraception that will help counteract deliberate disinformation
On December 23, 2022, the Food and Drug Administration (FDA) announced updates to the packaging information for Plan B One-Step, a type of emergency contraception. Emergency contraception (EC) is a birth control option that prevents pregnancy after contraceptive failure or unprotected sex, including in cases of sexual assault. The packaging has been updated to clearly state that Plan B One-Step prevents pregnancy by preventing ovulation, meaning it prevents ovaries from releasing an egg. With this action, the FDA removed problematic misleading language on the earlier packaging of Plan B One-Step and ensured that the packaging reflects the best scientific evidence. This update was in direct response to a request from the drug’s manufacturer, who wanted to ensure that the label for its FDA-approved product is scientifically correct and not misleading.
The Plan B label change is important not only because it aligns with science, but also because it could help thwart efforts to restrict access to emergency contraception. Anti-reproductive health advocates have long tried to confuse emergency contraception with drug-induced abortion, using the misleading prior label to deliberately confuse and repeat misinformation about how Plan B works. This label change is a critical rebuke to those efforts, made all the more timely by recent attempts to go for birth control in the wake of the Supreme Court’s decision to Roe against Wade.
The Department of Health and Human Services proposed a rule to prevent religious beliefs from dictating patient care.
In late December 2022, the Department of Health and Human Services’ Office for Civil Rights released a proposed rule that would repeal the most harmful provisions of a rule finalized in 2019 by the Trump administration that would have empowered individuals and institutions to refuse patient care based on their own personal and religious beliefs. The Trump denial of care rule made it more difficult for individuals to access care, including abortion care, and expanded which entities — from hospitals to ambulance drivers to planners — could put their personal beliefs above patient care. In addition, the Trump Refusal of Care Rule would have prevented potential healthcare employers such as Planned Parenthood from even asking applicants what services they would refuse to provide. This could have forced clinics to hire and retain a physician or other employees who are unwilling to do the job they were hired to do. The Trump denial of care rule also did not clarify that healthcare facilities still had to comply with the Emergency Medical Treatment & Labor Act, the federal law that protects patients in emergency situations.
The Trump denial of care rule was invalidated as illegal by several federal courts, including the Southern District of New York in a lawsuit brought by The National Women’s Law Center (NWLC), along with Planned Parenthood, Democracy Forward, and Covington and Burling in 2019 While the Trump rule on denial of care never went into effect because the courts blocked its application, HHS is taking an important step by announcing this rule update and ensuring that the Trump rule improves patient care does not harm. The new proposed rule recognizes the harm of the Trump rule of denial of care and its many successful legal challenges, largely repealing the earlier rule to remedy the legal flaws, clear up the confusion created by the Trump rule, and promote access to patient care .
The new proposed rule leaves in place the framework for enforcement of complaints under existing federal denial laws, amending the enforcement provisions of the Trump rule to ensure individuals are aware of their rights while protecting access to care.
Responses to the proposed rule are scheduled for March 6, 2023. HHS needs to hear from a range of stakeholders about the importance of repealing the harmful provisions of the Trump denial of care rule that allowed religion to dictate patient care. NWLC will work to support individuals and organizations interested in submitting comments.
The FDA took action to expand access to abortion medications at a critical time for access to abortion
In early 2023, the FDA took action to expand access to Mifepristone, a safe and effective drug that has been FDA-approved for over 20 years to terminate pregnancy. Medication abortion pills have several uses related to termination of pregnancy, including miscarriage, and have a better safety record than many commonly used drugs, such as Tylenol. Drug-induced abortion accounts for more than half of facility abortions in the United States and is becoming an increasingly important option for pregnant people as states take steps to limit or ban abortion in the wake of the Supreme Court ruling in June 2022. has taken away the constitutional right to abortion. .
Despite its safety record, Mifepriston has long been subject to medically unnecessary distribution guidelines, known as REMS (Risk Evaluation and Mitigation Strategy), which require personal delivery, a ban on dispensing pharmacies, and a ban on supply of the medicines by mail.
On January 3, 2023, the FDA permanently changed this REMS so that Mifepristone no longer needs to be personally dispensed. This is a long overdue change given mifepristone’s safety record and the fact that patients were not required to take mifepristone at the time it was dispensed, and could take the medication at home. It’s also something patients have done safely during the COVID pandemic, after the FDA suspended the in-person delivery requirement in April 2020 to limit face-to-face contact. Research has shown that eliminating the in-person requirement has the potential to significantly increase access to abortion care in the United States.
The FDA also lifted the restriction preventing the drug from being dispensed by retail pharmacies. Now, if a pharmacy takes the required steps to become certified, a person can fill their prescription at that pharmacy. Major pharmacies, such as CVS and Walgreens, have already announced plans to become certified distributors of mifepristone.
While the FDA’s action is an important step in expanding access to abortion, barriers will remain for those living in states that have banned abortion, as people will not be able to access their local brick-and-mortar pharmacy. visits to pick up the medication. In addition, many states have laws prohibiting or restricting the use of telehealth for abortion, which directly impacts pregnant patients seeking medical abortion in these states. Such barriers to access to medication and abortion disproportionately impact people in rural areas or counties with limited or no access to reproductive health providers.
The Justice Department has made it clear that the Comstock Act does not prohibit the shipment of abortion drugs
On December 23, 2022, the Department of Justice (DOJ) released a legal memo clarifying that a nineteenth-century law, first passed in 1873, that deems certain items “non-mailable” prohibits the shipping of medication- does not prohibit abortion. That federal law, the Comstock Act (18 USC § 1461), stipulates that certain items are “non-mailable” by the USPS, including items that may be considered “indecent” or that may be sent with the intent that the recipient commits crime. The General Counsel of the United States Postal Service asked DOJ for an opinion on whether the Comstock Act prohibits mailing medication abortions.
The DOJ determined that the Comstock Act does not prohibit the mailing, delivery, or receipt of abortion medications1 where the sender does not intend that the recipient of the medication will use it unlawfully. The DOJ’s analysis drew on decades of court rulings, dating back to 1912, and subsequent actions by Congress and the USPS regarding the scope of the Comstock Act. The determination that those involved in shipping drugs for abortion will not be liable under the Comstock Act reflects the entire government approach the Biden administration is taking to addressing the abortion crisis. Not only do we need the FDA to enact the measures that allow medication abortion to be shipped, but we also need the DOJ to make it clear that the federal government will not prosecute those involved in the shipping process under the Comstock Act. This DOJ action and the FDA action are intertwined and both are needed to expand access to medication abortion.
1 Comstock’s memo specifically referred to both mifepristone and misoprostol. Misoprostol is a safe and effective drug used for abortion care during pregnancy. Misoprostol can be used alone or in combination with mifepristone. In combination, these medication abortion pills can successfully terminate 80-95% of pregnancies without surgery. Ibis Reproductive Health, Misoprostol-alone medication abortion is safe and effective (2021), https://www.ibisreproductivehealth.org/publications/misoprostol-alone-medication-abortion-safe-and-effective.