One day, President Barack Obama is calling for open government and transparency. The next, the acting FDA commissioner, Frank Torti, is warning agency employees not to disclose information. In his memo, issued late last week, Torti didn’t mince words about the consequences – leaking confidential info may result in disciplinary sanctions, criminal charges or could cause the FDA to be sued for damages.
Although Torti paid lip service to open government and transparency, he went on to write that the FDA “must comply with its obligations to keep certain information in its possession confidential.” He then cited five types of info to be kept confidential: trade secrets; confidential commercial info; personal privacy data; law enforcement records and privileged intra-agency and inter-agency documents, such as emails, memos and letters between between FDA employees. Of course, these can be fodder for a good story.
An FDA spokeswoman told The In Vivo blog, which broke the story, that the unusual memo speaks for itself. Nonetheless, as In Vivo pointed out, the memo appeared after two episodes involving the discussion or release of what FDA officials may view as privileged info. In the first, FDA scientists wrote the Obama adminstration that the review process for medical devices was corrupted by agency managers. The other involved a prominent doctor who was booted from an FDA advisory panel just before it was to review an Eli Lilly drug. The wrinkle – the doctor was publicly critical of the drug and Lilly called the FDA to complain.
Coincidentally, this occurred just after the Association of Health Care Journalists urged the White House to end existing policies that require public affairs officers to approve journalists’ interviews with federal staff, including the FDA. The policies hamper newsgathering and make it difficult for reporters to fulfill their obligation to hold government agencies accountable, according to the AHCJ letter.