FDA bans ‘close-hold embargoes’ in response to AHCJ protest


usfda-logoThe Food and Drug Administration has banned a communications practice that troubled journalists and sparked protests from AHCJ and others.

The agency has forbidden its media staff from using “close-hold embargoes,” in which reporters receive early access to information provided they promise not to seek comments from others until the embargo lifts, according to a letter sent Thursday to Karl Stark, president of the Association of Health Care Journalists.

Writing on his last full day in office, Jason Young, the FDA’s acting assistant commissioner for media affairs, told Stark that close-hold embargoes had occurred occasionally but not recently, that they were in violation of FDA policy, and that media staff have been instructed not to use them under any circumstances.

“This is a great victory for AHCJ and all advocates for transparency, putting a clear end to a practice that impedes quality journalism,” said Stark, who wrote to Young in October protesting the practice. “Journalists who can’t seek outside comment on a government action or proposal are essentially barred from balanced reporting.”

Young said he considered it “exceptionally important” to resolve the embargo issue before leaving office. The practice had been the subject of an article in Scientific American and a column by Margaret Sullivan, then the New York Times ombudsman.

Asked in a phone interview what assurances reporters have that the FDA won’t violate the policy as it has in the past, especially with a new administration taking office, Young noted the agency has committed to the rule in writing, making promises to AHCJ as well as to others who inquired about it, including members of Congress.

Additionally, he said, staff throughout the agency have been trained in the rule, and it has become part of the annual training and orientation process for new press officers. He said he has worked to get “the entirety of the organization on the same page. Then it will persist over time and that’s the point.”

Young attributed the past policy violations to confusion about the rules in a vast agency with multiple divisions. He said that those responsible for those lapses no longer work at FDA.

Young noted that only five of the FDA’s 17,000 employees are political appointees, like him, who must resign with the change in administration. Among those staying behind is Heidi Rebello, deputy director of operations in the FDA’s Office of Media Affairs. Young described her as very knowledgeable on the embargo issue and urged journalists to contact her with any concerns at 301-796-4566 or heidi.rebello@fda.hhs.gov.

“To be quite honest with you, we have a number of former journalists who are on our staff who feel strongly about how the agency should operate,” Young said. “In fact, everyone’s aim upon seeing [AHCJ’s letter] was to act comprehensively and decisively in a way that would fix this issue going forward.”

In the process of reviewing the embargo question, the FDA decided to scrap its own embargo policy and instead adopt the media policy for the entire Department of Health and Human Services, which states: “HHS agencies may provide embargoed materials when the issue is not related to regulatory or enforcement issues and does not contain confidential, commercial information.”

Young’s letter said, “When the FDA announced its change to following only the HHS-wide policy, the Agency also reminded all media affairs staff that, for those times where an embargo may be appropriate…, journalists may share embargoed materials with their sources for reaction, so long as that third party also agrees to honor the embargo. The use of a ‘close-hold embargo’ is not to be used under any circumstances.” (Emphasis his.)

Referring to the underlined, boldface sentence, Young said, “Hopefully that leaves no room for interpretation or doubt.”

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Felice J. Freyer