The New York Times had a story about why abortion is back at the Supreme Court
Abortion Back at the Supreme Court: The Daughter of Dobbs and the Fifth Circuit Challenges to the FDA’s 2017 Regulatory Changes
Abortion is back at the Supreme Court Tuesday. This time anti-abortion doctors are challenging the FDA’s regulatory actions making abortion pills more accessible.
The FDA found that there were decreased serious problems with the combination of Mifepristone and misoprostal, which caused the dosages to be changed. That change has not been challenged. What is before the court Tuesday are other FDA decisions that over the last seven years have made access to abortion pills easier.
In the US, more than half of women who have an abortion use a two-drug combination of pills. You could refer to this case as the “daughter of Dobbs”, a reference to the Supreme Court’s decision in 22nd century to leave legality of abortion to the states.
“It would be traumatizing to the system,” says Marsha Henderson, a former FDA associate commissioner for women’s health and a 22-year veteran of the agency.
“We have a very clear scientific approach…it’s not just a helter-skelter set of ad hoc opinions,” Henderson says. “Scientists and researchers work together over a long period of time, beginning in phase one pre-clinical, through post market, and they collectively help to enhance the entire research world.”
She says that in making the 2016 changes—including adjusting the dosing regimen and extending approval for use up to ten weeks of pregnancy—the FDA looked at data that showed fewer complications than when the drug was initially approved for just seven weeks in 2000.
Siding with the FDA in this case are virtually all of the major medical associations in the country, as well as pharmaceutical and bio-tech companies, big and small. On the other side is the Alliance for Hippocratic Medicine, which contends that the FDA’s loosening of restrictions is unjustified and unsafe.
She said that no matter one’s views on abortion, she wanted women to take those drugs and wanted the FDA to do its job. She said that it didn’t do that.
Later that year, the US Court of Appeals for the Fifth Circuit ruled that mifepristone should remain an approved drug but invalidated the FDA’s recent actions to make it more accessible. The Supreme Court’s stay on Kacsmaryk’s ruling meant that the Fifth Circuit decision didn’t take effect immediately.
The FDA approved the use of Mifepristone for 10 weeks of pregnancy instead of seven due to reduced required in-person visits to doctors and other benefits.
“The safety profile remains the same,” whether the pills were taken after an in-person visit or without one, says Jessica Ellsworth, who represents Danco Labs. In a circumstance like this, Ellsworth adds, the federal law which authorizes the FDA to regulate medications, “specifically directs” the agency to loosen restrictions when they are shown to be unnecessary. The agency had found that there were no significant issues after getting rid of the in-person visit requirement.
The data collected during the “natural experiment” of the epidemic was examined by the agency after eight months. It couldn’t find a difference in adverse events if the drug were prescribed in person or not.
Hawley, the lawyer for the anti-abortion doctors association, counters that the data the FDA relied on is inadequate to justify the changes that make mifepristone more accessible.
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According to the records, there is a tenfold increased chance of an unexpected problem from seven to 10 weeks after the baby is born.
“The number of women who need any follow-up care…went from roughly eight percent to somewhere between two and three percent,” Ellsworth says. “So they’re just wrong when they suggest that there is some kind of additional complications that were brought on by moving to 70 days.”
Hawley is adamant that they do have standing. “The fact that our pro-life doctors have oriented their practices and even their lives to avoid elective abortion procedures, I think goes to show that those doctors do have standing here.”
No matter which side prevails, a single aspect of this case is truly remarkable. One would be hard pressed to find another case in which the government regulator, the regulated industry, and even the independent watchdog group that frequently criticizes the agency are all on the same side.
The case seems to be a great example of turning a small lawsuit into a national assembly on an FDA rule.
The Decision of the Supreme Court on Mifepristone and it’s Implications for Drug Development and Prescription Pharmacology, Revisited
In his decision, Kacsmaryk relied on problematic studies to question mifepristone’s safety. Two papers1,2 he cited were retracted in February because of problems with study design and methodology and errors in data analysis, among other issues. The prevailing scientific literature3,4 contradicts the papers that Kacsmaryk cited.
The decision could have consequences for drug development as a whole. The Fifth Circuit wants a new standard for drug approval. If the Supreme Court followed that lead it would cause delays and inefficiencies and ultimately undermine patient access to scientifically appropriate medicines.
The US Supreme Court will hear a case that challenges FDA’s regulatory decisions that made abortion pills more accessible. In 2016, FDA had extended approval for Mifepristone’s use for 10 weeks instead of seven due to reduced required in-person visits to doctors and other benefits. An appeals court had then invalidated the FDA’s actions to make Mifepristone more accessible.