On April 11, the Biotechnology Innovation Organization (BIO) signed on to an amicus brief calling for the suspension of a Federal District Court ruling that blocks access to a drug and undercuts the Food and Drug Administration’s (FDA) authority to bring treatments and cures to patients.
The April 7 ruling to put on hold FDA approval of mifepristone circumvents a “longstanding statutory and regulatory framework,” states to the amicus brief. Allowing the ruling to stand “would chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development,” the brief warns.
BIO’s executive committee unanimously agreed to join about 125 other signatories to the amicus brief, filed in the U.S. Court of Appeals for the Fifth Circuit.
“We will continue to organize and mobilize America’s scientific community to challenge this unprecedented effort to undermine the FDA’s expertise and to ensure that patients have access to safe and effective medicines,” says BIO President and CEO Rachel King. The decision “has consequences that extend well beyond the single drug, and stokes regulatory uncertainty in an industry responsible for bringing life-saving and life-enhancing therapies to vulnerable patient populations.”
Arguments in the brief include:
- The court, which lacks scientific or medical expertise, undermines the FDA’s ability to act on behalf of patients.
- The ruling is an assault on the importance of comparative safety data and would inhibit FDA’s broad acceptance of new data.
- The decision would create new regulatory barriers regarding approved labeling.
- BIO supports a balance between agency regulatory flexibility and judicial checks, but the ruling’s unprecedented obstacles “could upend crucial investment, research, and development in the biomedical field.”
The Justice Department asked the Fifth Circuit Appeals Court to suspend the ruling by April 13 while an appeal is underway, The Washington Post reported. This amicus brief also called for a suspension. Without it, access to the drug would be blocked on April 14.
The FDA under siege
The mifepristone ruling is “just the latest blow in an ongoing assault on the FDA’s authority,” according to BIO’s Dr. Cartier Esham, Chief Scientific Officer, and John Murphy, Chief Policy Officer, in STAT News.
From the “assault on the FDA’s long-standing accelerated approval program” to the decision on coverage of a breakthrough Alzheimer’s drug to Friday’s ruling, the FDA “is being systematically undermined in its efforts to advance and protect public health,” Esham and Murphy argue.
“As a result, both Americans and the biopharmaceutical companies that provide them with needed care and solutions are losing out.”