The Biotechnology Innovation Organization (BIO), which represents biopharmaceutical companies in the US, has signed onto an amicus brief to challenge a ruling from a federal district court in Texas that suspended the approval by the US Food and Drug Administration (FDA) of mifepristone, a contraceptive that ends pregnancy. The drug was first approved by the FDA in 2000 and has since had generic versions of the drug approved by the FDA.   

“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,” said Rachel King, BIO’s Interim President and CEO, in an April 7, 2023, statement. “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.” 

BIO re-affirmed its position when it announced earlier this week (April 11, 2023) that it had filed an amicus brief to challenge the ruling. An amicus brief may be filed by an individual or organization who is not a party to a legal case, but who is permitted to assist a court by offering information, expertise, or insight that has a bearing on the issues in the case. The amicus brief, which was filed in the US Court of Appeals for the Fifth Circuit, asks the court to suspend the district court’s ruling until the appeal can be heard. 

“We’ve repeatedly warned that the District Court’s decision would set a dangerous precedent for undermining 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,” said BIO’s King in an April 11, 2023, statement. “We stand ready to defend the regulatory, legal, and policy environment that prioritizes science and patients to create an ecosystem where innovators can continue ushering in the cures of tomorrow.” 

BIO highlighted four main points in the amicus brief as outlined below.  

Court lacks scientific or medical expertise and undermines the FDA. “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,” said BIO in its statement. “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.” 

Ruling compromises use of comparative safety data. “The District Court’s ruling is an assault on the importance of comparative safety data,” said BIO in its statement. “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.” 

Ruling creates new regulatory barriers for the FDA. “The District Court’s decision also would create new regulatory barriers for the FDA when it comes to approved labeling,” said BIO in its statement. “The ruling would place an unnecessary burden on the FDA and trial sponsors to justify each departure from clinical trial conditions in any approved labeling. This change, which is inconsistent with existing FDCA [Federal Drug and Cosmetics Act] guidelines and past practice, would have a significant chilling effect on the design of studies and investment in drugs to treat rare diseases and other unmet needs.” 

Ruling creates an imbalance between regulatory flexibility and judicial checks. “BIO has long supported a balance between agency regulatory flexibility and judicial checks on agency overreach,” said BIO in its statement. “However, the unprecedented obstacles sought to be implemented by the District Court could upend crucial investment, research, and development in the biomedical field, resulting in fewer breakthrough drugs for patients.” 

The full amicus brief may be found here.  

Source: Biotechnology Innovation Organization (BIO)