The Advanced Medical Technology Association (AdvaMed) this week raised concerns with a transparency task force’s recommendations regarding disclosures by the Food and Drug Administration. The trade association in particular warned that proposals to release more information before products are even approved and marketed would result in the release of trade secrets.
“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.”