FDA Confidentiality Post Shows What the Agency Can and Cannot Disclose

The Food and Drug Administration published an FDA Voices essay on February 26 arguing that protecting confidential information is central to the agency's review process. Barclay Butler, deputy commissioner for operations and chief operating officer, wrote that FDA must balance openness about the scientific basis of its decisions with "safeguarding the proprietary secrets of the industries it regulates." He wrote that while the Freedom of Information Act promotes disclosure, "other laws like the Trade Secrets Act and the Privacy Act mandate strict confidentiality," and that improper disclosure can lead to individual criminal liability, disciplinary action or lawsuits against the agency.

The essay lists the categories that usually stay out of public view: trade secrets such as manufacturing processes and formulas; confidential commercial information, including financial data and marketing strategies; personal data, including the identities of people who report adverse events; pre-decisional advice protected by the deliberative process privilege; and investigative records such as inspection reports. Butler also wrote that FDA information can move markets and that employees are barred from using nonpublic information for private gain.

How FDA's rules define a secret

The general rule is in 21 CFR Part 20. Section 20.61 defines a trade secret as "any commercially valuable plan, formula, process, or device" used to make or process trade commodities that is the end product of innovation or substantial effort, with a direct relationship to the productive process. Confidential commercial or financial information is valuable business information of a type customarily held in strict confidence. Data that fall into either category "are not available for public disclosure," the rule says.

Companies can designate information in their submissions as exempt from disclosure under exemption 4 of the Freedom of Information Act, in writing, and the designation expires 10 years after submission. When FDA receives a request for such records and decides disclosure may be required, it makes reasonable efforts to notify the submitter, who then has 10 working days to object. If FDA still decides to release the records, it explains why in writing and says it will disclose them five working days after the submitter receives the notice unless a federal district court orders otherwise.

Applications: sealed until approval

For drug applications, 21 CFR 314.430 sets a stricter line. FDA will not publicly disclose the existence of a new drug or generic drug application before it sends an approval or tentative approval letter, unless the existence has already been disclosed or acknowledged. If it has not, nothing in the application is available. Even when a company has announced its filing, no data from the application are released before approval, though the commissioner may disclose a summary of selected safety and effectiveness data for a pending public issue, such as an open advisory committee meeting.

After approval, the rule makes several categories available unless the applicant shows extraordinary circumstances. For a new drug, they include a summary of the safety and effectiveness data, test and study protocols unless shown to be trade secrets or confidential commercial information, and adverse reaction reports and consumer complaints with the names of patients, physicians and hospitals removed. Correspondence and written summaries of discussions between FDA and the applicant about the application are also covered, under the provisions of Part 20.

The essay closed by saying FDA's commitment to confidentiality "is what allows the private sector to share its most sensitive data with the government." It did not announce any change to FDA's disclosure rules.