On April 12, the 5th Circuit Court of Appeals ruled to partially block a Texas lower court ruling that sought to revoke Food and Drug Administration (FDA) approval for mifepristone, a medication commonly used to induce medical abortion.
The potential revocation of a medication widely and safely used for decades caused backlash from medical professionals and the biotech industry due to concerns about whether FDA approval of other medications would subsequently be revoked.
The April 12 federal appeals court ruling allowed some aspects of the lower court ruling to stand, including re-limiting access to the drug which had been expanded in 2016 to allow non-medical professionals to prescribe mifepristone to patients, as well as a 2021 decision that allowed it to be distributed through the mail.
As the courts deliberate, the drug remains accessible to patients, but on a more limited basis. Mifepristone’s ultimate fate may lie in the hands of the U.S. Supreme Court.
BIO joined amicus brief on Texas ruling
As we previously reported, the Biotechnology Innovation Organization’s Executive Committee filed an amicus brief urging suspension of the Texas ruling. The brief detailed the potential consequences of revoking FDA approval for a drug that has been on the market for years and is widely considered to be safe and effective.
The amicus brief discusses the fact that Congress empowered the FDA with the ability to approve or deny the safety of drugs, and claims the courts lack the medical expertise to make decisions affecting access to safe medical treatments for millions of Americans.
The brief also expresses concern that the ruling would undermine the FDA’s flexibility to streamline approvals during crises, hinder the ability of the FDA to accept new safety data, and slow the approval of complex medications. It states its support for strong judicial checks balanced with regulatory flexibility for federal agencies that are endowed with subject matter expertise.
Biotech industry says we should trust FDA’s expertise
The FDA employs medical experts who understand the drug approval process and are held to a high standard of safety. By undermining the independence and expertise of the FDA, however, the process of approving medications would become more cumbersome and cause a chilling effect.
BIO’s President and CEO, Rachel King, stated that a court system that undermines the FDA “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.”
“Here at BIO, we stand with a strong FDA and we stand with patients,” she said – watch below.
