March 12, 1998
Consumer Group Wins Access to Drug Data
Washington, D.C. — A federal judge has ruled that the Food and Drug Administration must release safety and effectiveness information about experimental drugs once manufacturers abandon efforts to seek approval for the drugs, except in extraordinary circumstances.
Public Citizen sought access under the Freedom of Information Act (FOIA) to safety and effectiveness information for four experimental drugs that were being tested on humans as part of the FDA’s Investigational New Drug Application (“IND”) process. The testing of each drug was halted because of health or safety concerns. The two manufacturers of the experimental drugs — Schering Corp. and Hoechst Marion Roussel — intervened in the case to fight release of the data.
“The court’s decision not only provides public access to particular drug safety information in this case but guarantees that the public will generally have access to information about drugs that have been abandoned because they pose unreasonable risks to patients,” said Lucinda Sikes, staff attorney for Public Citizen Litigation Group. “Congress recognized that the public should have access to this data, but until now the information was generally held secret by the FDA at the insistence of drug companies.”
In a March 11 ruling, U.S. District Judge Royce Lamberth of Washington, D.C., found that a provision of the Waxman-Hatch Amendments to the Food, Drug and Cosmetic Act in 1984 requires that safety and effectiveness data be released to the public when no work is going to be undertaken to have the drug approved and no extraordinary circumstances exist.
Based on this disclosure provision, Lamberth ordered disclosure of data concerning three experimental drugs sponsored by Schering, because Schering conceded that it has abandoned their development and did not point to any “extraordinary, uncommon or otherwise atypical” circumstances that differentiate the competitive value of its data from the data concerning any other abandoned drug.
Lamberth did not order disclosure of data concerning HMR’s experimental drug because he was satisfied that HMR had not abandoned pursuit of FDA approval for its drug.
In earlier phases of the litigation, Public Citizen obtained access to tens of thousands of pages of drug safety data related to the experimental drugs of four other drug companies when those companies withdrew their objections to the release of the information.