PhRMA opposes EMA, FDA transparency policies

The Pharmaceutical Research and Manufacturers of America released written comments asserting FDA's proposal to publish clinical trial data would put patient privacy at risk, lead to "unjustified second-guessing of FDA's regulatory decisions," and provide competitors with data that could facilitate "approval of competing products with little effort or investment." PhRMA also said the proposal would result in the illegal release of trade secret and/or confidential commercial information. FDA is seeking comments on a proposal to release patient-level data that identifies drug classes but not individual products (see BioCentury, July 22).

Similarly, PhRMA believes EMA's proposal to make patient-level data available to researchers would place "all of the IP a company develops as a result of R&D" in the public domain, PhRMA President and CEO John Castellani told BioCentury. ...