Considerations For Protecting Trade Secrets In FDA Correspondence

Companies seeking approval from the U.S. Food and Drug Administration (“FDA”) to market a new drug or biological product must submit extensive information to the FDA in support of approval. FDA submissions will often include information that a company considers to be a trade secret. Such information is exempt from public disclosure under the Freedom of Information Act (“FOIA”) Exemption 4 if it falls within the FDA's definitions of (1) a trade secret or (2) confidential commercial or financial information:

(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process.