The FDA and ‘Confidential Commercial Information’

The Food and Drug Administration’s (FDA’s) approach to information sharing dates from 1974. A half-century later, the agency’s policies and procedures are out of date and counterproductive, at times frustrating efforts to advance and safeguard public health. For example, when requests are made under the Freedom of Information Act (FOIA) for clinical trial data about new drugs or vaccines or details about the supply chains involved in drug shortages, the FDA often releases heavily redacted documents that provide little useful information.

A fascinating Viewpoint article in JAMA, published in July 2024, examines the origins of “confidential commercial information” at the FDA and makes the case for a “long overdue” and “more balanced” approach to the public disclosure of company information.[1] Although it is easy to get lost in the legal weeds, the central thesis is that a half-century ago the “FDA effectively tied its own hands by fashioning a rule requiring that all confidential information falling within the FOIA exemption be withheld from the public.” Daval and Kesselheim argue that the FOIA exemptions are discretionary, not mandatory, and that the agency “can untie its own hands by amending its regulations from 1974.”

In 1974 the FOIA was relatively new, having been enacted in 1966. Although the FDA had discretion in addressing exemptions under the FOIA, such as for “‘trade secrets’ and certain other ‘confidential’ information that an agency may not want to make public,’” the authors found that the FDA privileged “the keeping of company secrets over the public welfare: ‘Even if such disclosure would be in the public interest, [or] in order to protect public health,’ the FDA wrote, ‘such disclosure cannot be lawfully undertaken.’”

The reasoning related to the agency’s interpretation of its obligations under the Trade Secrets Act, a still-older (1948) law that “prohibits federal employees from divulging information relating to a company’s ‘trade secrets, processes operations’ or ‘confidential statistical data’ under threat of up to 1 year of imprisonment.” The FDA chose “to promise to disclose nothing at all that could be construed as a ‘trade secret’ or ‘confidential commercial information.’”

In 2024, what do Daval and Kesselheim recommend the FDA do differently? First, the FDA should change its own regulations and no longer provide “a blanket commitment to confidentiality.” Second, the agency should draft new regulations that “identify what types of information the agency considers disclosable and the circumstances under which the agency could share it.” For example, new regulations could allow for prompt disclosure of information that could affect the public health, such as particulars about the reasons for drug shortages or detailed clinical trial data about the safety and effectiveness of new drugs and other currently marketed products. Finally, the FDA could work with the Department of Justice “to define the bounds of the Trade Secrets Act” and narrow the circumstances under which its employees need to be concerned with its provisions.
 

References

[1] Daval CJR, Kesselheim AS. The origins of “confidential commercial information” at the FDA. JAMA. 2024;332(7):533–534. doi:10.1001/jama.2024.9639.