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Washington, D.C. – Yesterday, more than 500 executives at pharmaceutical and biotech companies signed on to a letter rebuking the decision by Judge Matthew Kacsmaryk to block the FDA’s 22-year-old approval of mifepristone. The letter has been signed by leaders of prominent companies in the pharmaceutical industry, including Pfizer, Biogen, Merck, Bayer, Novartis, and AbbVie Ventures.

Noting that “the decision ignores decades of scientific evidence and legal precedent,” the authors write, “Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in doing so, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. ” 

The authors warn of the dangers of this type of judicial overreach for other drugs on the market, arguing that “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.”  

Read the full letter here.

Read Planned Parenthood’s statement on the ruling here, and Planned Parenthood’s statement on the Department of Justice’s and Danco Laboratories’s appeals here.

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