Steve Nissen isn’t a fan of the newest memo circulated at the FDA:
My comedic instincts tell me to ask whether the memo in question was leaked:
In a staff memo Friday, FDA Deputy Commissioner Frank Torti outlined prohibitions on disclosure of commercial information that “can result in disciplinary sanctions and/or individual criminal liability” or could cause the FDA to be sued for damages. Concern over keeping trade secrets is routine in government.
. . . .
In an interview this week, Nissen said the agency allows companies too much leeway in branding important material on safety and efficacy as commercial or proprietary information, and that agency leaders disclose too little about their interactions with industry lobbyists and lawyers. “I’m a little stunned that the FDA would send this [memo] out at this time,” Nissen said. “I wonder what some of the people on the Hill think.”
Joking aside though, the FDA should err on the side of disclosure. FAR on the side of disclosure.