Tag: scaring

While Kacsmaryk stayed his decision until Friday and the Biden administration has already appealed to the 5th U.S. Circuit Court of Appeals, the ramifications from Friday’s decision for the FDA and the drug industry could be felt for decades regardless of how this case is ultimately decided.

Here’s what we know:

Will the decision turn the FDA approval process “upside down”?

Experts disagree. Kacsmaryk’s ruling focused on the procedures around mifepristone’s approval and the FDA’s delayed response to petitions from anti-abortion organizations asking the agency to reconsider. It did not directly address FDA’s approval authority, said Greer Donley, an associate professor at the University of Pittsburgh law school.

“The stay itself has no other impact on any drug other than mifepristone,” she said.

The concern, she said, is that the precedent, in this case, could be used to implicate other drugs should groups choose to challenge the procedures surrounding their approval.

Jane Henney, who was FDA commissioner when mifepristone was approved, said Monday that “this ruling sets a very dangerous precedent for the FDA’s authority in terms of other new medications.”

“Clearly, we would be entering totally uncharted territory in that regard,” she said during a call with reporters.

Beccera’s worry that other medical products are at risk was echoed by leaders in the pharmaceutical industry.

Pfizer CEO Albert Bourla was among the dozens of pharmaceutical executives to sign a letter calling for an immediate reversal of the ruling, citing the “uncertainty for the entire biopharma industry.”

“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” the letter said.

And William Schultz, former deputy commissioner for the FDA and former general counsel for HHS, said the decision “could allow virtually anyone to challenge any FDA drug approval decision with a good chance of succeeding.”

“Any FDA drug approval involves hundreds of judgments by the agency. If a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those judgments is wrong,” Schultz said.

HHS did not immediately respond to a request for comment on Monday.

What happened in Washington state and how does it affect the Texas ruling?

Just after Kacsmaryk’s ruling, U.S. District Court Judge Thomas Rice in the Eastern District of Washington issued a conflicting order that blocks the FDA from rolling back access to the pills in the dozen blue states and Washington D.C. that brought the lawsuit. This seeming contradiction is one reason many believe the case is headed to the Supreme Court.

The Department of Justice on Monday asked the judge in Washington state to clarify the injunction while Danco, which manufactures and sells mifepristone under the name Mifeprex, and the Department of Justice have filed appeals to the conservative-leaning 5th U.S. Circuit Court of Appeals.

Donley noted that it is technically possible for the FDA to comply with both rulings by using its enforcement discretion to look the other way if companies distribute a drug that no longer has the agency’s approval.

“The only way for the FDA to comply with both orders is to allow the drug to become unapproved … but then issue a guidance document or something similar saying ‘We are not going to enforce the Food, Drug and Cosmetic Act against the manufacturers and distributors of mifepristone, so long as those manufacturers and distributors follow these carefully articulated rules,’” she said.

Would that work?

Andrew Pincus, a visiting lecturer at Yale Law School and an experienced Supreme Court and appellate attorney, said that may not be enough assurance for manufacturers and other potentially liable entities.

“It’s not clear that enforcement discretion is a route to give them the assurance they need,” Pincus said.

What would happen if mifepristone is removed from the market?

Misoprostol, the second drug in the two-pill regimen used for medication abortions, will still be available for patients across the country even if mifepristone is banned. The drug isn’t subject to the FDA’s drug safety program like mifepristone because it’s used for many non-abortion purposes, including treating stomach ulcers, making it harder to challenge and ban. Although the drug is commonly used alone for abortions in other countries, it has slightly higher rates of requiring surgery to complete an abortion than using misoprostol and mifepristone together.

“It would be devastating from a lot of different perspectives and there would be a lot of patients who would be left with a less-optimal regimen to manage pregnancy loss and abortion care,” Jennifer Villavicencio, an OB-GYN and member of leadership at the American College of Obstetricians and Gynecologists, told reporters on Monday.

In theory, Danco — or any other drug maker — could also resubmit an application for mifepristone’s approval. However, it could take two to three years for a drug maker and the FDA to go through another approval process, said Kirsten Moore, the director of the Expanding Medication Abortion Access Project, on a press call.

Why are drugmakers so concerned?

The pharmaceutical industry said the Texas lawsuit could curb drug development in the U.S. and throw the regulatory framework FDA uses to approve drugs into question if the case is upheld by higher courts.

“This decision has ramifications that extend well beyond this case, setting a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies,” Biotechnology Innovation Organization interim CEO Rachel King said on Saturday.

If the Supreme Court upholds Kacsmaryk’s decision, the industry would likely push Congress to pass legislation to cement the FDA’s authority, according to John Murphy, chief policy officer and deputy general counsel of healthcare at BIO.

“If that were to survive through sort of a theoretical SCOTUS challenge, you really have to look at Congress to ensure we get back to having FDA in the driver’s seat here,” Murphy said.

What are Democratic governors doing to support mifepristone access while the case winds its way through the courts?

Massachusetts Gov. Maura Healey announced Monday that she has requested UMass Amherst and state-contracted health care providers to stockpile mifepristone and issued an executive order “confirming protections for medication abortion under existing state law.”

The university purchased about 15,000 doses last week to ensure coverage for more than a year, with more doses expected to be purchased, and Healy is also allocating $1 million to help providers who are contracted with the state Department of Public Health purchase the drug.

The move comes on the heels of an announcement from Washington Gov. Jay Inslee who is having his Department of Corrections purchase a three-year supply of mifepristone. State lawmakers have introduced legislation to allow the department to sell mifepristone to licensed health providers across the state.

And in California, Gov. Gavin Newsom announced the state has secured an “emergency stockpile” of up to 2 million misoprostol pills, with 250,000 pills having already arrived in the state.