Medical Device Industry to FDA: Your Transparency Plans Implicate Our Trade Secrets

The Hill is reporting that the Advanced Medical Technology Association (AdvaMed) has recently raised concerns with a transparency task force’s recommendations regarding disclosures by the Food and Drug Administration. AdvaMed's statement is synopsized below:

“These draft proposals, while well-intentioned, would have a number of negative effects,” writes Technology and Regulatory Affairs Vice President Janet Trunzo in 21 pages of comments. “They would undermine intellectual property rights. They would create competitive harm, disadvantaging originator companies, especially small companies, relative to competitors. They would benefit foreign competitors, providing them with heretofore unavailable intellectual property and commercially sensitive information. Most important, they would reduce the attractiveness of financially risky investments in novel, breakthrough products; ultimately harming the public health by limiting the development of new treatments and diagnostics.”

Again, more in the private vs. public vein of trade secret risk. We'll continue to report about this forecasted battle.