D.C. CIRCUIT–The federal Food and Drug Administration does not have to release drug manufacturers’ pre-clinical reports of tests of drugs that resulted in deaths or serious injuries and caused drug companies to abort plans to develop those drugs, the U.S. Court of Appeals (D.C. Cir.) ruled in early August.
The appeals panel, saying that release of the safety reports on the early tests could cause the drug manufacturers substantial competitive harm, allowed the government to exempt them from disclosure under the federal Freedom of Information Act.
It also ruled that disclosure of these early tests is not covered by a law requiring the FDA to disclose testing results actually submitted along with a new drug application, even when the application is subsequently abandoned by its sponsor.
The panel partially reversed a March 1998 decision by the federal District Court in Washington, D.C.
Public Citizen Health Research Group in Washington, D.C., had requested the records of the early investigatory drug tests that had caused serious adverse results. When the records were were denied, it sued the FDA. Schering Corporation joined the FDA in the lawsuit, arguing that disclosure of records of its tests of an antifungal drug would tip off competitors to studies it was making of a successor drug.
Public Citizen said “competitive harm” created by releasing early health and safety information would be minimal. Competing drug companies might avoid spending time developing and testing a dangerous drug, it said, but disclosure of these tests would also save future human participants from dangerous clinical research. The benefits of disclosure would clearly outweigh any competitive harm, the group said.
The group also argued that the federal law, which requires the FDA to disclose safety and effectiveness data submitted with an application to manufacture a new drug, applies to the whole process of testing, noting that the pre-clinical tests also must be submitted to FDA for approval. It makes no sense, it said, to require disclosures of dangers discovered late in the process, but not early in the process. It also noted that FDA regulations implementing this law require disclosure of the health and safety data submitted in investigational drug trials as well as with new drug applications.
(Public Citizen Health Research Group v. FDA; Counsel: Amanda Frost, Washington, D.C.)