Following heavy criticism, FDA says controversial embargo policy is “not to be used under any circumstance”
Several months after a damning expose demonstrating that the Food and Drug Administration (FDA) was violating its own official policy by using a controversial embargo practice, the agency has said it will no longer use so-called “close-hold embargoes.”
Such embargo agreements restrict whom reporters can talk to before embargoes lift, unlike standard embargoes in which journalists can share information for comment as long as their sources understand it is under embargo. I’ve called this an attempt to turn reporters into stenographers.
In a letter today to the Association of Health Care Journalists (AHCJ), outgoing FDA Acting Assistant Commissioner for Media Affairs Jason Young acknowledges that at times, the agency’s policy “was not adequately followed.” And Young — whose last day at the FDA is today, ahead of the Presidential inauguration — writes (bolding his) that
The use of a “close-hold embargo” is not to be used under any circumstance.
(Disclosure: I am vice president of the AHCJ board of directors, but this post reflects my personal views, not necessarily those of the AHCJ.)
In light of recent interest in these matters, the Agency took a closer look at its adherence to this policy. While the FDA does not maintain a comprehensive, consolidated record of all instances where an embargo has been used, in preparing to respond to interested stakeholders, we did find occasions on which the embargo policy was not adequately followed. As such, we have taken steps, detailed below, to ensure that all FDA media affairs staff are aware of, and regularly trained on, our embargo policy and process to ensure future adherence.
We found that the FDA’s use of “close hold embargos” – that is, telling reporters not to share embargoed materials with third parties for a quote during the embargo period, even if that third party would agree to uphold the embargo – occurred in the past, as has been reported, but that this has not been used recently. This approach, though, runs counter to our policy, and therefore is now included as a special point of emphasis in our staff training.
The FDA has also decided to eliminate their embargo policy, replacing it with the overall HHS policy on the subject. All of this, Young wrote, was announced to media affairs staff on October 19, 2016.
My AHCJ board colleague Felice Freyer writes that she asked Young why reporters should believe 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 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.
My NYU colleague Charles Seife, whose September Scientific American piece revealed conclusively that the FDA had deliberately used a close-hold embargo in 2014 despite having promised the AHCJ in 2011 that it wouldn’t, seemed to share a “trust but verify” view. He tells Embargo Watch:
We’ve heard this before, and if they obey their own rules, that’s a positive step forward, but given their history of noncompliance with their own policies, I remain skeptical.
Seife pointed out, however, that Young’s statement to Freyer that those responsible for the lapses no longer work at FDA does not ring true.
I find it fascinating that Young insists that those responsible for the policy violations no longer works at the FDA and then refers any further questions to Heidi Rebello, Deputy Director of Operations in the FDA’s Office of Media Affairs, whose e-mails show that she was one of the people who was most actively involved in breaking those rules.
I was not able to reach Young by phone or email to ask about the discrepancy. (Not surprising, since as noted, today is his last day at the FDA.) [See update.]
Seife went on:
The claim that they are using embargoes “so that reporters may seek necessary clarifications and translate these complex issues into plain language,” given that a good proportion of embargoes that I found were advertising campaigns, or very simple to understand ideas, belies their underlying reason for having these embargoes in place in the first place, let alone close-hold embargoes. I do not think that reporters are so stupid that they need a couple of extra days to understand the latest “smoking causes cancer” advertising campaign.
Update, 6:15 p.m. Eastern, 1/19/17: In a statement, Young said:
The FDA communications leadership at the time of the violations has moved on. FDA’s frontline staff are dedicated public servants who have tried their best to follow our policy and we have now provided the clarity, training and support they need to fully adhere to the policy going forward.