BIO JOINS AMICUS BRIEF CHALLENGING COURT’S EFFORTS TO UNDERMINE FDA’S AUTHORITY TO BRING TREATMENTS AND CURES TO PATIENTS “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’s King   The Biotechnology Innovation Organization (BIO) today signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to a single drug known as mifepristone) that would create regulatory barriers and potentially upend FDA’s authority to approve life-saving and life-enhancing therapies to patients. The amicus brief, which was filed in the U.S. Court of Appeals for the Fifth Circuit, asks the court to suspend the District Court’s ruling until the appeal can be heard.  BIO’s executive committee unanimously agreed to have BIO sign onto this amicus brief.   The brief makes the following arguments:   The District Court – which does not have the needed scientific or medical expertise – undermines the FDA’s ability to act independently and quickly on behalf of patients. Currently, the FDA has the clinical flexibility to streamline review of drugs with a meaningful therapeutic benefit to patients, especially as it relates to medicines that treat rare and orphan conditions. The District Court ruling misconstrues the FDA’s authority, while also substituting the court’s scientific judgement for the FDA’s.   The District Court’s ruling is an assault on the importance of comparative safety data. If upheld, the ruling would inhibit the FDA’s broad acceptance of new data – including real world evidence – and evidence to support post-approval changes. Such a paradigm would severely disrupt critical pathways for the development and approval of complex drugs today, thereby slowing the approval of complex drugs for patients in the future.   The District Court’s…

A federal judge in Texas rules this week to suspend the FDA’s approval of mifepristone. BIO interim President and CEO, Rachel King, released the following statement:  “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.  “This decision has ramifications that extend well beyond this case, setting a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies.  “As this case works its way through the appeals process, it is our hope that this ruling is overturned, so that patients and drug developers can rely on the rigorous FDA approval process as the scientific and trusted standard for drug approvals.  “We are seeing amazing breakthroughs in labs across the country. We are on the cusp of groundbreaking new medicines that will transform the standard of care for our loved ones. We need a regulatory, legal and policy environment that reflects the needs of these patients, respects the expertise of our nation’s leading scientists and protects the ecosystem that allows medical breakthroughs to go from the bench to a patient’s bedside.”