Delia A. Deschaine, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Law, in “Abortion Pill Legal Fight Leaves FDA Grappling with Response,” by Celine Castronuovo, Ian Lopez, and Jeannie Baumann. (Read the full version – subscription required.)
Following is an excerpt:
The US Supreme Court’s decision to send back to a lower court a fight over the FDA approval of a widely used abortion pill tees up complicated legal questions over politicized medical treatments and the federal government’s authority over them.
In blocking lower court bans on the abortion drug mifepristone for the duration of a legal battle over the drug’s availability, the Supreme Court has allowed lower courts to scrutinize the process the FDA used to approve the drug 23 years ago and whether a century-old federal law prohibits the distribution of the abortion pill mifepristone by mail. …
Comstock Act
Another area that remains uncertain for the FDA is how courts plan to interpret a provision of a 150-year-old federal law, the Comstock Act, that prohibits the mailing of items designed to induce an abortion.
The law states that any “article or thing designed, adapted, or intended for producing abortion” is “nonmailable.”
The law hasn’t been enforced for decades, and an assistant US attorney general in the Justice Department’s Office of Legal Counsel said in a Dec. 23 memo that federal law doesn’t prohibit the US Postal Service from mailing and delivering mifepristone or misoprostol, in part because the drugs could be used for other purposes like miscarriage management.
Abortion opponents maintain the law blocks the mailing of drugs for ending pregnancies. In its order on the Biden administration’s request to stay the Kacsmaryk ruling, the US Court of Appeals for the Fifth Circuit suggested it read the Comstock Act as blocking the mailing of mifepristone. …
Yet how the Comstock Act is ultimately applied “will most likely turn on how the Supreme Court rules, and, unfortunately, the Court has not yet indicated which way it will go,” Delia Deschaine, an attorney at Epstein Becker & Green specializing in FDA regulations, said in an email.
Should the plaintiffs in the Texas case, Alliance Defending Freedom, succeed, legal experts say the door would be open for interest groups and others to go after other drugs.
“We could see ADF or other groups using the Comstock Act to challenge the mailing of abortifacients or other drugs that the groups find morally offensive, including possibly HIV medication,” Deschaine said.
‘Ever-Changing Landscape’
While the Supreme Court’s stay helps maintain the status quo for patients and medical providers as litigation continues, there’s a patchwork of state and federal laws that is likely only going to grow more confusing, attorneys say.
“The ever-changing landscape of mifepristone’s approval, both brand and generic, has only made that compliance more complicated and therefore uncertain,” Deschaine said.
As Democratic-led states seek to broaden access to the abortion pill in the Washington case, generic mifepristone manufacturer GenBioPro is challenging West Virginia’s abortion ban, arguing that federal regulations on the pill preempt the state’s law. It adds that the state law violates the US Constitution’s commerce clause by interfering with interstate sales of an approved drug.
The US District Court for the Southern District of West Virginia said in an April 21 order that GenBioPro could proceed with its lawsuit regardless of decisions in the ADF case.
The GenBioPro case “could further complicate the compliance quandary as there could be three, or more, overlapping decisions regarding the approval of generic mifepristone,” Deschaine said.