FDA Memo on Leaks Gets Leaked

NEWS TRENDS

On March 13, FDA's then-acting commissioner Frank Torti issued a memo warning staff about leaking confidential information. Three days later, a copy of his memo surfaced on the In Vivo blog. Torti, who was recently replaced by Joshua Sharfstein, used the memo to remind staff that a violation of the laws relating to confidentiality can result in “disciplinary sanctions or individual criminal liability.”

Communication that reveals trade secrets, commercial data, and personal privacy information were among the offenses outlined. The sharing of privileged interagency documents such as internal e-mail and memoranda—the category that Torti's memo falls under—were also banned.
Some media speculated that the memo was intended to silence those planning to follow in the footsteps of nine FDA whistle-blowing scientists. The so-called dissidents recently aired an agency dispute to members of Congress and President Obama's transition team. They claim that a politician unfairly influenced FDA's approval of an imaging device.
Larry Pilot, who served as special assistant to the FDA commissioner in the 1970s and helped create the Office of Medical Devices, says he doesn't necessarily think Torti's memo was a reaction to the scientists' assertions. The memo could have been spurred by recent changes in the administration, the staff's anxiety about the changes, or the recent heightened media interest in the agency, he says. “Maybe it was a good time to remind people of their responsibility to the agency.”
FDA spokeswoman Siobhan DeLancey describes the memo as routine. “Dr. Torti sends out all-hands memos to the FDA staff every Friday of issues that may be of particular importance…he simply felt it was an appropriate topic,” she says.
Although Pilot strongly supports FDA's need to protect trade secrets and commercial information, he also says that it could be more responsive to the people that are directly affected by its decisions, such as the applicants of various submissions.
This sentiment is echoed by Yadin David, founder of Biomedical Engineering Consultants (Houston) and a former member of several FDA advisory panels. He says that more of the discussion at FDA should be public because it could help the parties seeking approval “to better understand the permission process and what needs to be done.”
In addition to issues of transparency, Torti's memo also raises questions about employees' ability to seek recourse. If a review process is corrupted at FDA, as the nine scientists recently charged, how can employees right the situation without revealing confidential information? DeLancey says that the agency shields employees through its support of the Whistleblower Protection Act. It also has a Scientific Dispute Resolution program that allows employees to appeal to a review board when they disagree with decisions.
Pilot says that FDA staff should follow the internal process when they have grievances. “It is unfortunate that the subordinates feel motivated to complain directly to Congress rather than to complain to supervisors,” he says. However, he does acknowledge the possibility of staff complaints being inadequately handled.
“There are too many incompetent managers both in the field and in the office,” Pilot says. According to him, it is essential for the next FDA commissioner to be sensitive to personnel issues and have a good “next-level layer of competent managers.”
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