In A Post-Dobbs World, Pharmacists Still Face Uncertainty

News
Article
Drug Topics JournalDrug Topics September 2023
Volume 167
Issue 08

Legal challenges have made dispensing abortion medications more difficult than ever.

Since the nineteenth century—well before the Supreme Court made their landmark decision in Roe v Wade—there have been abortion laws on the books. However, after the landmark decision in 1973, these laws were never repealed, creating a set of legal challenges following the Dobbs v Jackson Women’s Health Organization decision on June 24, 2022.

Perhaps more crucially for pharmacists, though, is that “none of those laws had to do with medication abortion,” said Scot Hasselman, co-chair at Reed Smith LLP,—creating additional confusion when some of those laws when into effect following the Dobbs decision. “It’s very challenging being a retail pharmacy, especially being a chain that is across numerous jurisdictions, because you’re trying to figure out, ‘What is the law today? What can we do today? What are our obligations [around] providing health care?’”

Hassleman and his colleague Lesley Reynolds, a partner at Reed Smith LLP, shared their insights into a post-Dobbs pharmacy world during a presentation at the 2023 National Association of Chain Drug Stores Total Store Expo, held August 12 to 14 in San Diego, California.

The Federal Government Responds

On the day of the decision, the Department of Justice (DOJ) and Attorney General Merrick B. Garland released a statement responding to the ruling. In that statement, Garland and the DOJ clarified what, legally, states and the federal government could and could not do:

  • States cannot ban an approved medication based on a disagreement with the FDA;
  • States cannot impose either criminal or civil liability on a federal employee acting within the scope of their employment; and
  • Federal agencies may continue to provide reproductive health services.

On July 11 and July 13, the Department of Health and Human Services (HHS) issued their own responses to the Supreme Court decision. First, Secretary Xavier Becerra reaffirmed that compliance with the Emergency Medical Treatment and Labor Act (EMTALA) includes offering life-saving abortion services to patients who are experiencing medical emergencies. Two days later, issued guidance to retail pharmacies with a reminder about Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, age, disability, or sex, which includes pregnancy, sexual orientation, gender identity, and sex characteristics, through covered health programs or activities.

Another issue that retail pharmacies must contend with is the Comstock Act, an “anti-vice” law put on the books in 1873 that criminalized using the United States Postal Services to mail contraceptives and abortifacients, along with other substances.

State-Level Reactions

In the course of the Dobbs decision, the Supreme Court overruled both Planned Parenthood v Casey and Roe v Wade, finding that “there was no federal constitutional right to abortion, and that this was an issue for the states,” Reynolds noted. “The majority opinion noted that [the goal was] to get the courts out of the issue of abortion. That’s not really what has come [to be].”

“[Abortion] has been litigated at an incredible rate,” she continued, “due to the numerous laws being challenged and legislators enacting new proposals.” In some states, such as Kentucky, Louisiana, Mississippi, and Oklahoma, among others, trigger laws banning abortion went into immediate effect; in Georgia, Wyoming, and Indiana, legislation proposing a variety of additional restrictions was proposed, some of which is still pending. And in Idaho, legislators have criminalized bringing minors across state lines to receive abortion care—including medication that will induce abortion—in a law known as “abortion trafficking.”

State attorneys general have also taken public positions on these state and federal laws. Earlier this year, 20 Republican attorneys general signed letters to both CVS and Walgreens warning the pharmacy chains that their intention to distribute abortion pills through the mail were illegal under the Comstock Act, directly contradicting earlier DOJ guidance. In response, Walgreens agreed that they would not dispense abortion pills—either in the pharmacy or by mail—in those states, a list that includes several states where both abortion and abortion medications remain legal. In response, a group of Democratic state attorneys general issued their own letter urging Walgreens and CVS to ignore these threats of legal action.

For pharmacists—and especially for pharmacists practicing near state lines—these conflicting directives have further muddied the waters around an extremely contentious issue.

“Alaska is a state that has a state constitution where…reproductive rights are protected; essentially there’s a right to abortion in Alaska,” Hasselman said. “There are also laws on the books in Alaska that limit the performance of an abortion to certain locations, and they must be performed by certain individuals—certain types of providers—so you have a law that essentially doesn’t really provide a pathway for dispensing abortifacients in a pharmacy, arguably."

The question then becomes, he said, “How do you sort of square those two?” The state attorney general has taken the view that pharmacists cannot dispense abortifacients in a retail pharmacy; that’s not technically inconsistent with the state constitution. “The constitution…just says that there is a right, and there’s a statute that says that right is limited to certain locations and certain practitioners, and that doesn’t include retail pharmacy.”

“And so, you’re a dispensing pharmacist in Alaska, what do you do?” asked Hasselman. Pharmacists who defy these statues risk discipline, such as a loss of their license or legal action, and administrative hearings challenging disciplinary action can languish in court for years.

Mifepristone Under Challenge

Pharmacists are also likely familiar with the recent legal challenge of mifepristone, where the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists, among others, brought a lawsuit claiming that the FDA was inappropriate in their approval of mifepristone in 2000.

On August 16, a panel of judges in the 5th US Circuit Court of Appeals ruled that access to mifepristone must be restricted and ordered a ban on both telemedicine prescriptions and shipments of the drug by mail. The decision will need to be reviewed by the Supreme Court, and the DOJ has stated that the Biden Administration will be appealing the ruling.

In the meantime, what are retail pharmacists supposed to do? According to Hasselman and Reynolds, that answer remains unclear.

“The answer depends…on the state in which you’re sitting,” Reynolds said. “In some states, pharmacists cannot dispense and would be subject to…licensure actions [or] other criminal statutes depending on the state.”

“There are a lot of states where we’ve advised pharmacies not to dispense at all,” Hasselman said.

Reference
Hasselman S, Reynolds L. Post Dobbs for pharmacy. Presented at: NACDS TSE 2023; August 12-14, 2023; San Diego, CA.
Related Videos
© 2024 MJH Life Sciences

All rights reserved.