Tyler's Departure As FDA Chief Counsel Leaves Another Chair To Fill
This article was originally published in The Tan Sheet
Ralph Tyler is leaving FDA 18 months after taking the helm as the agency's chief counsel. FDA Commissioner Margaret Hamburg sent a memo June 30 to FDA staff stating that Tyler would be leaving the agency for health reasons. His final day with the agency is Aug. 5. "Ralph is known for his unwavering dedication, sharp thinking and dry wit," Hamburg wrote, adding that he "has been a force for good while here at FDA."
Tyler was Maryland's insurance commissioner before joining the agency. He was encouraged to apply for the job by FDA's then-Principal Deputy Commissioner Joshua Sharfstein (Also see "FDA Chief Counsel Has History With Sharfstein" - Pink Sheet, 21 Dec, 2009.). Sharfstein left FDA in January to lead the Maryland health department and John Taylor took over his post on an acting basis (Also see "FDA Congressional Relations, Internal Structure May Change With Sharfstein Exit" - Pink Sheet, 17 Jan, 2011.). The agency said it has neither chosen a successor to Tyler nor named anyone to fill his position in the interim. Department of Health and Human Services acting General Counsel William Schultz likely will play a strong role in that decision. Schultz, a former FDA deputy commissioner for policy and one-time staffer to Rep. Henry Waxman, D-Calif., took the HHS post on an acting basis earlier this year. He joined HHS from the law firm Zuckerman Spaeder. A Dozen-Plus Posts Filled On Acting Basis Tyler's departure adds to a lengthy list of vacancies within the Office of the Commissioner. As of the beginning of May, an agency chart showed 13 leadership posts lack permanent appointees, including the Office of Policy, Planning and Budget, where David Dorsey is the acting deputy commissioner; the Office of Women's Health, for which Marsha Henderson is acting director; and the Office of Special Medical Programs, where Jill Wamer is acting associate commissioner. Five other positions in the commissioner's office, in addition to chief counsel, remain vacant, including administrative law judge, deputy chief scientist and assistant commissioner of the Office of Public Affairs. It is unclear if possible replacements for Tyler have been named. Prior to Tyler's appointment, Michael Landa served as acting chief counsel; Landa is now acting director of the Center for Food Safety and Applied Nutrition (Also see "CFSAN Post May Remain Unfilled Pending Food Safety Legislation Passage" - Pink Sheet, 17 May, 2010.). During his tenure, Tyler emphasized the importance of regulation to assure the safety of food and drugs. He noted that in preparation for the job he read Upton Sinclair's 1906 classic "The Jungle," which describes horrific conditions in Chicago slaughterhouses (Also see "FDA Chief Counsel Ralph Tyler Begins Tenure With A Focus On "The Jungle"" - Pink Sheet, 1 Feb, 2010.). Tyler also defended regulatory moves that many questioned as being beyond FDA's legal authority – including a request that physicians temporarily stop prescribing GlaxoSmithKline's Rotarix vaccine so its safety could be assessed. "A cramped view of the FDA is not a view which protects the American public," Tyler said in a speech last year. "That is true as a matter of policy and that is true as a matter of law." Tyler said lawyers are not doing their job when they say, "No." He said the client should be dictating the result, not the lawyers. "The science, the medicine, the food industries move faster than Congress," he said. "To just say, 'The door is shut,' is not helpful." |