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An analysis of Food and Drug Administration policy by researchers at Harvard University School of Public Health (HSPH) and at Brigham & Women's Hospital determined that the FDA should allow greater access to its drug safety information to allow for greater scrutiny of potentially dangerous drug effects.

“As it stands right now, many times the information is not made fully public because the pharmaceutical industry considers it trade secrets,” said co-author of the study, Dr. Aaron Kesselheim, attorney and medical researcher for Brigham & Women's.

The study is set to appear in the March/April issue of Health Affairs .

The Current Approval Process

As it stands now, drug companies submit their own safety data along with their approval application to the FDA, who reviews the documents and decides whether to approve the drug. Due to confidentiality concerns, however, the FDA releases only summaries of the drug's safety issues – not the actual data.

One of the problems noted by the Harvard researchers was that independent researchers often have to file lawsuits to obtain the data. This is a wasteful, time-consuming process. The researchers do not believe that releasing such data would jeopardize trade secrets.

An Unfair Advantage for Competitors?

“The legal question is whether the information will give other drug companies an unfair competitive advantage,” said associate professor of health policy and law at HSPH, Michelle Mello. “But it is strange to argue that evidence that a drug is harmful will enable others to develop similar drugs,” she said.

Data that showed the outcome of drug trials and how the drug affected certain patient populations would be especially useful to physicians and independent researchers, said Kesselheim.

Recommendations

In their analysis, the researchers advocated “placing a heavier burden of proof on companies to show competitive harm if data are released.” They also recommend the FDA replaces their drug data summaries with more comprehensive reports, including study data.

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