Experts worry two recent rulings challenging the Food and Drug Administration’s regulation of a drug used in medication abortions threaten to complicate the agency’s oversight and the pipeline for future research and drug approvals.
On Friday, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas suspended the FDA’s approval of mifepristone, which the agency approved more than 20 years ago. The order, which would stop the manufacture and distribution of the drug, will go into effect Saturday without a higher court granting emergency relief.
Separately, U.S. District Judge Thomas Rice in the Eastern District of Washington ruled Friday that the agency should not modify the drug’s regulations as a case challenging the FDA’s risk mitigation restrictions specific to the drug moves forward.
Jane Henney, who served as FDA commissioner when mifepristone was approved in 2000, said the Texas ruling “would set a very dangerous precedent for the FDA’s authority in terms of other new medications that might warrant movement into the marketplace.”
“I can assure you that the approval process was both comprehensive and quite thorough and was done according to our standard procedures at FDA, done by the career staff who make their recommendations on approval of any product at the agency,” said Henney, adding that staff considered clinical data, preclinical data, the manufacturing process, epidemiology and toxicology before making its decision.
The White House has said it does not plan to buck the court decision if it goes into effect, but multiple officials have said the decision would set a dangerous precedent. But some Democrats — and in at least one case, a Republican — have pushed for the FDA to use enforcement discretion.
Republican Rep. Nancy Mace of South Carolina, who has been outspoken on wanting House Republicans to shift from focusing on anti-abortion messaging to other priorities, said Monday on CNN she agreed the administration should “ignore” a court decision limiting approval of the drug.
“This is an issue that Republicans have been largely on the wrong side of. We have over the last nine months not shown compassion towards women. And this is one of those issues that I’ve tried to lead on as someone who’s pro-life and just have some common sense,” said Mace.
Anti-abortion advocates criticized her remarks.
“The FDA is not beyond reproach, as we have seen time and again with other drugs from Vioxx to opioids,” said E.V. Osment, vice president of communications for SBA Pro-Life America, on Tuesday, referring to an anti-inflammatory drug Merck withdrew from the market in 2003. “But they will never be held accountable if leaders like Mace encourage them to ignore the law and the science.”
Rep. Tony Gonzales, R-Texas, speaking on CNN Sunday, said if the administration does not adhere to the Texas ruling, there may “come a point where House Republicans on the appropriation side have to defund FDA programs that don’t make sense.”
Research implications
The Texas ruling outraged the pharmaceutical industry, with more than 250 biopharma executives issuing a joint letter saying they “stand together to unequivocally support the continued authority of the FDA to regulate new medicines.”
“It just really messes up the risk benefit, profit loss calculus that drugmakers have to go through, if you’re going to arbitrarily withdraw your approval 20 years after the fact,” said Kirsten Moore, director of Expanding Medication Abortion Access Project.
Nancy Northup, president and CEO of the Center for Reproductive Rights, said the Texas ruling meant “virtually anybody who opposes an FDA-approved drug could drag the agency into court to challenge their decision.”
“One issue created by Judge Kacsmaryk’s erroneous ruling is that he allowed the plaintiffs in this case — anti-abortion groups of doctors — to have standing to bring the case at all,” she said.
She said doing so could destabilize the research and development of new drugs through FDA’s accelerated approval program which targets treatments for serious or life-threatening conditions such as cancer or Alzheimer’s.
Kacsmaryk using a narrow interpretation of what is a serious or life-threatening condition has the potential to “drastically narrow the scope of the FDA’s expedited programs,” she said.
“This rigidity and second-guessing threatens to hobble the FDA’s ability to approve critical new medications and the ability of the pharmaceutical companies to bring new medications to market,” Northup said.
William Schultz, a partner at Zuckerman Spaeder and former FDA deputy commissioner and HHS general counsel, said the decision sets a precedent to allow “virtually anyone to challenge any FDA drug approval decision with a good chance of succeeding.”
Schultz criticized the Texas decision for considering only six scientific factors, including whether an ultrasound test is required and the psychological impacts of the procedure, in determining if mifepristone should have been approved, compared to the hundreds used by the FDA’s scientists and for including outside evidence like blogs, which is unusual for reviewing agency decisions.
He said if the decision is upheld it “could have a devastating effect on drug and vaccine development in this country.”
Next steps
If the decision goes into effect on Saturday, it could create additional confusion for providers and facilities that have existing stock of mifepristone. Two states, Massachusetts and Washington, have already stockpiled the drug in anticipation of a ban.
Moore suggested that whether doctors can prescribe the existing supply may be dependent on FDA’s guidelines for a controversial pregnancy drug.
Last week, the FDA pulled its approval of Makena, the only drug prescribed for reducing the risk of preterm births. The drug was greenlit under accelerated approval pathway in 2011, but has faced scrutiny over its efficacy in subsequent clinical trials.
When the FDA pulled the drug from the market, Moore said, the agency acknowledged that some of the supply is still in circulation and advised patients to speak with their providers on if they could still take it, she said.
“If the product is already in clinics or on pharmacy shelves, typically it can still be dispensed, [and] prescribed,” Moore said, though it cannot be manufactured or distributed.
Henney said that scenario was a possibility but did not rule out a drug recall.
“I think there’s a whole range there up to and including a total recall, and sometimes with that people, you know, who might have it in their pharmacy are asked to send it back,” she said. “This is a unique circumstance and a unique time and how extreme that recall might be, I think, is really a question that’s up in the air.”
— Lauren Clason contributed to this story
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