Nearly 300 biotechnology and pharmaceutical company executives on Monday slammed a ruling from a federal judge in Texas that invalidated the Food and Drug Administration’s (FDA) decades-old approval of the abortion medication mifepristone.
The executives in an open letter called for the decision to be reversed and argued that the judicial interference will undermine FDA’s authority.
“The decision ignores decades of scientific evidence and legal precedent. Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” wrote the executives, including Albert Bourla, chief executive of Pfizer.
Mifepristone was first approved by the FDA in 2000 and has been proven safe and effective. It’s one of two medications used to induce a medical abortion in the U.S.
Drug industry experts, current and former administration officials and abortion rights advocates have been sounding the alarm that U.S. District Court Judge Matthew Kacsmaryk’s ruling in favor of anti-abortion groups would have far-reaching consequences for FDA’s authority.
The decision “undermines our nation’s entire system of drug approval. It opens the door for courts to overturn FDA’s evidence-based decisions for purely political or ideological reasons,” Health and Human Services Secretary Xavier Becerra said in a statement Friday after the ruling.
If the decision is upheld, it could open the door to any third party to challenge any medication or treatment that they disagree with, including vaccines for children, AIDS drugs, birth control or hormone therapy.
“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 executives wrote.
William Schultz, a partner at Zuckerman Spaeder and former FDA deputy commissioner, told reporters during a briefing Monday that the ruling adds another barrier for bringing drugs and treatments to the market.
“In order to get a drug approved, companies will not just have to survive literally often hundreds of millions of dollars and years of testing [and] FDA scientific review, but then they’ll have to survive challenges in court, which could be immediate, or as in this case, 20 years later,” Schultz said.
The pharmaceutical industry’s lobbying group had been largely silent on the issue since the lawsuit was first filed and on Monday again declined to comment on the specific lawsuit over abortion drugs.
“The FDA is the gold standard for determining whether a medicine is safe and effective for people to use,” said Priscilla VanderVeer, the group’s vice president of public affairs. “While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines.”
The biotechnology lobbying group BIO was more forceful in its response, calling the decision “an assault on science.”
“For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations,” interim President and CEO Rachel King said in a statement.
