More than 200 biopharma groups, which include a number of drugmakers led by Pfizer, have signed an open letter blasting the decision by Texas federal Judge Matthew Kacsmaryk to issue a hold on federal approval of mifepristone, the most commonly used method of abortion in the U.S.
The letter criticized Kacsmaryk for having issued the ruling despite having ‘no scientific training’ and said his decision has ‘undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American.’
‘The decision ignores decades of scientific evidence and legal precedent,’ the drugmakers wrote. ‘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.’
In addition to Pfizer CEO Albert Bourla, the letter was signed by representatives for Merck and Biogen, as well as industry nonprofit groups like the Center for Medicine in the Public Interest.
In his ruling last week, Kacsmaryk sided with an anti-abortion group that had challenged the FDA’s decades-old approval of the drug.
‘The Court does not second-guess FDA’s decision-making lightly,’ Kacsmaryk wrote in his decision. ‘But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.’
The case is likely to make its way to the Supreme Court.
Separately, the primary lobbying arm of the pharmaceutical industry, PhRMA, issued a statement Monday saying Kacsmaryk’s ruling undermines the regulatory process.
‘The FDA is the gold standard for determining whether a medicine is safe and effective for people to use,’ the organization said. ‘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.’
