Recent news articles bring to the forefront the fact that the FDA is not necessarily a united agency with a common set of goals. In May 2008, Frank Torti joined the FDA as Principal Deputy Commissioner and new Chief Scientist. Many were encouraged by this appointment since Torti’s background is academic, not political — seemingly the perfect selection for a position charged with oversight of this federal agency.
Under Torti’s direction, by the end of summer 2008 the FDA had added 1,300 people to the agency’s ranks. Torti promoted the additions by saying it represented the first incremental hiring for the 11,000-person agency in “many, many years. The regulatory agenda for the FDA has grown substantially in the last 20 years while its work force has remained largely flat,” he added. Torti definitely has a point there. Technologies have been changing at lightning speed and the FDA is responsible for oversight of this broadening array of devices, drugs and advances. Nanotechnology developments and their applications to possible disease treatment is leaving the FDA with the puzzle of deciding whether to class them as devices or drugs.
And beyond the technology advances, 2008 ended up providing a string of food and drug emergencies that kept the agency hopping… Tainted peanuts. Unsterilized syringes. Salmonella originally thought to be in tomatoes and then ultimately in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.
In March, Torti sent a confidential memo warning FDA staff about leaking confidential information. (A memo which was itself rapidly leaked to the public!) Shortly afterward, Torti sent a farewell memo to the FDA staff urging them to “Take the FDA back.” Humorously for the general public (not the agency), this memo was also leaked to the public in short order!
Here is an excerpt from Torti’s farewell memo after his less-than-one-year stint with the FDA: “The FDA is now defined by others. You must speak up and take the FDA back. It is yours, not theirs. You do more good, day in and day out, than most others, inside or outside government. FDA has a mission, of course. But what you give the FDA is character and class.”
The hope of promise with Torti’s appointment and his rather quick exit amid the cloak-and-dagger text of his farewell memo leaves us wondering what could possibly be going on within the agency walls.