Amici are pharmaceutical companies, pharmaceutical company executives, and industry investors, including Pfizer Inc., Gilead Sciences, Inc. and Biotechnology Innovation Organization, the world’s largest advocacy organization for biotechnology.
The Pharmaceutical Industry amici explain that Congress has delegated FDA the authority to determine the safety and efficacy of new drugs and that the agency properly exercises that authority by applying rigorous scientific scrutiny to new drug applications. The FDA’s broad authority to fulfill its mandate includes determining what kinds of data and studies are needed to make the necessary safety and efficacy findings.
The District Court distorted the drug-approval process by replacing FDA’s rigorous scientific analysis with personal conclusions drawn from cherry-picked studies and anecdotes. The pharmaceutical industry amici stress that the District Court’s wrongheaded approach will empower any plaintiff, regardless of their motives, to file a lawsuit challenging FDA’s scientific expertise, would wreak havoc on drug development, and limit the public’s access to crucial medication. This precedent would have an industry-wide impact, causing devastating harm to patients, providers, and the entire pharmaceutical industry.
This brief was one of many filed in support of the FDA in Alliance for Hippocratic Medicine v. FDA. For more information on the case, click here.