BBJ: Biotech leaders double down, backing FDA in amicus brief after abortion pill ruling

Apr 12, 2023

By Rowan Walrath, Boston Business Journal

The following excerpts are from an article originally published by the Boston Business Journal on April 12, 2023.

Days after issuing an open letter condemning a federal judge’s decision to revoke the U.S. approval of a widely used abortion pill, biotech leaders have filed an amicus brief in support of the FDA.

More than 150 biopharmaceutical leaders signed on to a brief filed Tuesday with the U.S. Court of Appeals for the Fifth Circuit. In the brief, they argue that the Texas district court’s ruling late last week blocking the approval of the abortion pill mifepristone “radically alters” the process of drug approval, undermines the authority of the U.S. Food and Drug Administration and creates a chilling effect on pharmaceutical innovation.

“Far from being limited to one drug, the logic of the district court’s order overturns the long-settled legal basis of FDA’s drug-approval process,” the brief reads. “Unless stayed, the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines. That outcome would chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development and approval generally, causing widespread harm to patients, providers, and the entire pharmaceutical industry.”

Meanwhile, the local trade group MassBio — short for the Massachusetts Biotechnology Council — has also condemned the Texas district court ruling.

“The judicial interference by a federal judge in Texas is not only an attack on access to basic medical care for women across the country, but it also threatens the very processes that have been established to deliver safe and effective treatments and therapies to patients,” said CEO Kendalle Burlin O’Connell. “Our members face enough obstacles during the drug development process as it is. Injecting this type of uncertainty and non-scientific politics will have a significant impact on innovation and investment in medicines to address unmet medical needs.”

Read the full article in the Boston Business Journal.

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