FDA's New Chief Counsel Was Sharfstein's Lawyer

FDA has named Ralph Tyler, currently Insurance Commissioner of Maryland, the agency's new Chief Counsel.

Tyler's appointment comes through his ties to FDA Principal Deputy Commissioner Joshua Sharfstein. The two worked together when Tyler was Baltimore City Solicitor and Shaferstein was Baltimore Health Commissioner.

Tyler said in an interview that Sharfstein encouraged him to apply for the position. "I was his lawyer once before and have the opportunity to be his lawyer again," he said.

FDA's Office of Chief Counsel reports directly to HHS. But the choice and method of selection here suggest Tyler will be a close member of the commissioner's team.

While Tyler has no background in food and drug law, he has been a regulatory and administrative lawyer for more than 30 years.

Prior to becoming Insurance Commissioner two years ago, he was Chief Legal Counsel to Maryland Governor Martin O'Malley and before that was Baltimore City Solicitor. He also was a litigation partner at Hogan & Hartson and served in the Maryland Attorney General's office from 1982 to 1996 as Deputy Attorney General and Chief of Litigation and Assistant Attorney General.

"I think he's going to be terrific for FDA," said Hogan & Hartson partner Robert Brady, who cited Tyler's commitment to public service and his reputation as a brilliant litigator as key assets. Brady noted that there have been great general counsels without FDA experience and that Tyler's management experience will be important for running the agency's 80-attorney Office of General Counsel.

As Baltimore City Solicitor, Tyler led a successful lawsuit against the Maryland Public Service Commission which had sought a 72 percent utility rate increase. As Deputy AG, he handled the Fifth Amendment case Baltimore City Department of Social Services v. Bouknight involving the right against self-incrimination.

During his tenure at Hogan & Hartson, he handled numerous pro bono cases. In one case he won compensation for Bernard Webster, incarcerated for 20 years for a crime it was proven he did not commit. Tyler also brought a 1998 case that resulted in the release of more than 50 men who were unlawfully re-incarcerated following the state's recalculation of their criminal sentences.

Tyler will take over from Mike Landa, who has served as acting chief counsel since April. Landa will return to his position as Deputy Director for Regulatory Affairs at the Center for Food Safety and Applied Nutrition. Landa, who joined FDA in 1978, has held various positions with the agency, including deputy chief counsel from 2000-2004 (¹ (Also see "FDA Acting Chief Counsel Choice Landa Underscores Administration Priorities" - Pink Sheet, 10 Apr, 2009.)).

- Brenda Sandburg ( ² [email protected] )