Experts explore strategies to improve FDA’s disclosure of confidential commercial info

The US Food and Drug Administration (FDA) has several avenues it can pursue to improve its disclosure of confidential commercial information (CCI), according to a recent article published in JAMA by members of the Program On Regulation, Therapeutics, And Law (PORTAL) group at Brigham and Women’s Hospital and Harvard Medical School.

“There are a lot of public health benefits that could come from more transparency related to certain aspects of FDA decision-making, but the FDA’s historical interpretation of confidential commercial information has stymied progress on that front,” Aaron Kesselheim, professor of medicine at Harvard Medical School and director of PORTAL, told Focus. “Our analysis suggests that the FDA has a lot of flexibility in reconsidering that historical approach and coming to a more modern application of CCI that could still protect reasonable trade secrets while providing greater information about its decision-making to benefit patients.”

Kesselheim and co-author C. Joseph Ross Daval said FDA’s usual approach when asked to disclose information related to safety and efficacy of new drugs or supply chain information that might benefit public health is to express reluctance to share CCI and trade secrets. “FDA sometimes takes this position grudgingly; agency officials often express frustration at how legal impediments prevent them from publicizing useful information,” the authors wrote.

This issue goes back to 1974, when FDA issued a rule implementing the Freedom of Information Act (FOIA), as well as the Trade Secrets Act, which prevents the agency from disclosing information to the public considered trade secrets and other confidential information. The agency argued it had to create the rule because violating the Trade Secrets Act carried a threat of imprisonment. “Although FOIA exemptions are discretionary—they give agencies the option not to disclose information in response to a FOIA request—in 1974, FDA effectively tied its own hands by fashioning a rule requiring that all confidential commercial information falling within the FOIA exemption be withheld from the public,” they said.

However, the authors argued that FDA could loosen the restrictions it has placed on itself, noting a 1979 Supreme Court ruling that found “the Trade Secrets Act does not prevent information sharing if it is ‘authorized by law,’” and that FDA could use its rulemaking authority to authorize release of information if it is in the public interest. Daval and Kesselheim also said it is unlikely that violation of the Trade Secrets Act would result in jail time for FDA officials in practice, pointing out that the Department of Justice (DOJ) typically prioritizes “egregious misconduct.”

“It would be unprecedented for a DOJ attorney to prosecute an FDA employee for publicizing information under an official FDA policy intended to promote the public health,” they wrote.

What is more of a barrier is if a company decides to sue FDA to prevent the agency from disclosing information by claiming it violated the Trade Secrets Act. “Even if FDA prevails, the cost of this litigation against corporations with vast resources may be prohibitive,” the authors said.

FDA has a number of options at its disposal to mitigate these barriers, Daval and Kesselheim explained. The agency could amend the 1974 regulation implementing FOIA because it is subject to its own regulation regardless of federal law. “Rescinding a blanket commitment to confidentiality is the necessary first step,” they noted. Communicating with the DOJ about the limits of the Trade Secrets Act and how it would relate to the agency’s disclosure of CCI would help define the bounds of what DOJ is willing to enforce, and could include assurances to not prosecute FDA officials for disclosure of information under pre-defined scenarios or edge cases.

Another step is for FDA to create a notice-and-comment rule that authorizes public disclosure of information, which could “allow for the immediate disclosure of any information the agency determines could substantially affect public health and safety, such as information on supply chains and manufacturer production capacity to combat cancer drug shortages, or relevant safety or efficacy information about products currently on the market.”

As of now, FDA’s stance seems unchanged on this matter. Kesselheim told Focus that former FDA commissioner Scott Gottlieb expressed interest in some of the recommendations for transparency developed by faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health back in 2017, but there was no follow up by the agency. “That’s the last I’ve heard from FDA about this,” Kesselheim said.

When asked if the Supreme Court’s ruling overturning Chevron deference could impact future FDA policy changes, Kesselheim noted it is possible the agency would receive greater scrutiny under the new approach (RELATED: Experts: Chevron deference ruling could impact recent FDA regulations, Regulatory Focus 2 July 2024).

“I think as long as any new approaches to transparency are well justified and based in a reasonable interpretation of the law, FDA should not have anything to worry about,” he said.

JAMA Daval et al.

Experts explore strategies to improve FDA’s disclosure of confidential commercial info

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