Drugmakers sign letter supporting FDA and calling for reversal of Texas judge’s mifepristone drug ruling
Pfizer CEO Albert Bourla and dozens of other biotech and pharmaceutical company leaders have signed an open letter in support of the US Food and Drug Administration’s authority “to approve and regulate safe, effective medicines for every American” after Friday’s decision by a Texas district court judge to halt the agency’s approval of mifepristone, one of the medications used in abortion procedures.
US District Judge Matthew Kacsmaryk said Friday that he will suspend the FDA’s approval of mifepristone, the first of two drugs used in a medication abortion, after a weeklong stay to allow for appeals. On Monday, the US Department of Justice asked a federal appeals court to put a hold on the ruling.
Access to reproductive health care has become more challenging for women in the US, study shows
The letter called for a reversal of Kacsmaryk’s decision, saying it “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, 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. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry,” the letter says.
The letter also warns that if the judicial system “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.”
In a separate statement, the biotech industry group BIO’s interim president and CEO, Rachel King, emphasized the “dangerous precedent” the Texas judge’s decision sets.
“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. 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,” King said.
Published April 11, 2023
https://edition.cnn.com/
US District Judge Matthew Kacsmaryk said Friday that he will suspend the FDA’s approval of mifepristone, the first of two drugs used in a medication abortion, after a weeklong stay to allow for appeals. On Monday, the US Department of Justice asked a federal appeals court to put a hold on the ruling.
Access to reproductive health care has become more challenging for women in the US, study shows
The letter called for a reversal of Kacsmaryk’s decision, saying it “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, 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. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry,” the letter says.
The letter also warns that if the judicial system “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.”
In a separate statement, the biotech industry group BIO’s interim president and CEO, Rachel King, emphasized the “dangerous precedent” the Texas judge’s decision sets.
“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. 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,” King said.
Published April 11, 2023
https://edition.cnn.com/
