Trade Secrets and the FDA
By Press
From MarketWatch, a report on a new study which argues that the FDA should provide more public access to safety data from clinical trials of the drugs it approves.
The study by a group of researchers at Harvard and elsewhere concludes that allowing more access to the data would provide independent researchers greater opportunity to scrutinize potentially dangerous side effects of the new drugs.
Pharmaceutical companies, somewhat predictably, are concerned that release of such information threatens their trade secrets.
According to Dr. Aaron Kesselheim, the study's co-author, "the information is not made fully public because the pharmaceutical industry considers it trade secrets."
Under the current regime, the FDA only releases to the public summary safety data and not the actual data.
The study appears to be more in the continuing pressure of drug companies to make clinical trials data publicly available and trade secrets be damned.
The study by a group of researchers at Harvard and elsewhere concludes that allowing more access to the data would provide independent researchers greater opportunity to scrutinize potentially dangerous side effects of the new drugs.
Pharmaceutical companies, somewhat predictably, are concerned that release of such information threatens their trade secrets.
According to Dr. Aaron Kesselheim, the study's co-author, "the information is not made fully public because the pharmaceutical industry considers it trade secrets."
Under the current regime, the FDA only releases to the public summary safety data and not the actual data.
The study appears to be more in the continuing pressure of drug companies to make clinical trials data publicly available and trade secrets be damned.
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