The Food and Drug Administration's proposed plans for creating a more transparent medical-product approval process could potentially expose trade secrets and be detrimental to innovation, according to a letter submitted to the agency by the Advanced Medical Technology Association, a devicemaker lobby group.
AdvaMed warns of threat to trade secrets
The letter was in response to a request for comment on a public-disclosure policy report issued by the agency in May. In the report, an FDA task force detailed draft proposals for 21 specific actions aimed at providing clinicians, healthcare-product manufacturers and the public with better insight into the FDA’s decisionmaking process. The proposals include recommendations for the FDA to make available to the public an explanation for denying approval of a medical product; disclose the receipt of investigational applications; and release summaries of safety and efficacy data submitted in product-approval applications.
But in its response to the draft proposals, AdvaMed said such disclosures could be harmful to its devicemakers. The lobby group argued, for example, that disclosure of investigational applications could alert potential competitors to key information about a medical device’s intended use and indications.
“These draft proposals, while well-intentioned, would have a number of negative effects,” wrote AdvaMed Executive Vice President of Technology and Regulatory Affairs Janet Trunzo in the organization’s comment letter. “They would undermine intellectual property rights. They would create competitive harm, disadvantaging originator companies, especially small companies, relative to competitors.”
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