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BIO JOINS AMICUS BRIEF CHALLENGING COURT’S EFFORTS TO UNDERMINE FDA’S AUTHORITY TO BRING TREATMENTS AND CURES TO PATIENTS

April 11, 2023
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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 decision also would create new regulatory barriers for the FDA when it comes to approved labeling. 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 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.
     
  • BIO has long supported a balance between agency regulatory flexibility and judicial checks on agency overreach.  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. 

 
BIO interim president and CEO, Rachel King, made the following statement:
 
“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.
 
“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.
 
“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 approved medicines. BIO is eager to work alongside advocates, activists, scientists, researchers, entrepreneurs, doctors, and drug developers who support sound science and the FDA’s authority as the case makes its way through the appeals process.”
 
Find the filed brief here.
 

 

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