A recent memorandum of understanding between FDA and CMS for routine sharing of product data stresses that trade secret information will be protected by both agencies, at risk of civil and criminal penalties.
In Data-Sharing Pact, FDA And CMS Vow To Protect Trade Secrets
By Jessica Bylander
A recent memorandum of understanding between FDA and CMS for routine sharing of product data stresses that trade secret information will be protected by both agencies, at risk of civil and criminal penalties.
The memo, first announced by CDRH Director Jeffrey Shuren at a June 24 FDA workshop, was released in its entirety last week.
The MOU promotes collaboration between the agencies and marks a potential first step toward parallel reviews for marketing approval and Medicare coverage. Industry has expressed concerns, however, that trade secrets could be compromised since CMS does not have the same statutory obligations for confidentiality as FDA.
Firms need not fear, the text of the memorandum suggests. According to the pact, both agencies must protect certain types of information from unauthorized disclosure. The memo specifically mentions trade secret and other confidential commercial information; personal privacy information; and information that is otherwise protected from public disclosure by federal statutes, including the Food, Drug and Cosmetic Act and the Trade Secrets Act.
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