Drug Litigation Newsroom

FDA Should Release More Drug Safety Data: Experts

Changes need to be made to the U.S. Food and Drug Administration's policy regarding the confidentiality of drug safety data from clinical trials, say researchers at the Harvard School of Public Health and Brigham and Women's Hospital in Boston.

Current rules allow drug companies to keep data secret, which prevents the public from learning about dangerous side effects of drugs, the researchers said. Allowing greater public access to this data would enable outside experts to independently evaluate the data and perhaps detect risks sooner.The researchers noted that consumer groups have used lawsuits under the Freedom of Information Act to access drug safety data, but these efforts have yielded mixed results. Litigation is expensive, and it can take years for a case to make its way through the legal system.

The FDA and the drug companies say drug information needs to be protected so that competing manufacturers can't use the data to produce competing versions of drugs. However, the commentary authors argue that making drug safety data public rarely poses a risk to a company's confidential research and development programs.

"The legal question is whether the information will give other drug companies an unfair competitive advantage. But it is strange to argue that evidence that a drug is harmful will enable others to develop similar drugs," noted co-author Michelle Mello, an associate professor of health policy and law at the Harvard School of Public Health.

Mello and co-author, Dr. Aaron Kesselheim, a lawyer and member of the department of pharmacoepidemiology at Brigham Women's Hospital, said the FDA should change its policies to allow scientists access to drug safety data before and after a New Drug Application is approved.

The authors recommended that:

• A heavier burden of proof be placed on companies to show competitive harm if safety data are released.
• The FDA replace the current Summary Basis of Approval with a more comprehensive public document that includes all safety data.
• Congress passes a law that requires public disclosure of safety data if the FDA fails to take action.

"Safety data from drug clinical trials have important ramifications for public health. The government should do as much as it can to ensure full disclosure of the information," Kesselheim said.