FDA’s decision to make Elizabeth Dickinson permanent chief counsel was welcome news to those within and outside the agency, who hailed her as the perfect person to oversee the raft of legal issues confronting the agency.

“I am wildly enthusiastic about the choice,” said Peter Barton Hutt, who held the position of chief counsel in the 1970s. “She is a very warm, friendly, hard-working model chief counsel” and is “equally loved outside and inside the agency.”

Hutt, now senior counsel at Covington & Burling, also praised Dickinson’s skills as a lawyer, noting that one of her primary responsibilities has been implementing the Hatch-Waxman Act.

“She’s incredibly smart, particularly in the areas essential to FDA’s mission,” said Coleen Klasmeier, a partner at Sidley Austin who served as special assistant to former FDA chief counsel Dan Troy. “She has the trust, support and dedication of the entire legal team and is appropriately accessible to outside stakeholders.”

Dickinson was appointed acting chief counsel in August, following the departure of Ralph Tyler Also see "FDA's Elizabeth Dickinson Is Named Acting Chief Counsel" - Pink Sheet, 12 July, 2011.. Tyler had been Insurance Commissioner of Maryland before taking the post in January 2010, and he left FDA after 18 months for health reasons. He joined the law firm Venable LLC in November.

FDA signaled the potential for an internal selection when it converted the chief counsel position to a career post from a political position following Tyler’s departure Also see "As FDA Reorganizes, Office Of Chief Counsel Becomes Less Political" - Pink Sheet, 18 July, 2011.. Dickenson becomes the first career government staffer to be named FDA’s permanent chief counsel since Margaret Jane Porter was tapped for the post in 1989 ([A#00510410011]). Porter had an unusually long tenure and was succeeded by Dan Troy, who is now GlaxoSmithKline Inc.’s general counsel, in 2011 Also see "FDA Chief Counsel Is Attorney From WLF Case; Porter Leaves After 11 Years" - Pink Sheet, 13 August, 2001..

FDA Commissioner Margaret Hamburg announced Dickinson’s permanent appointment in a Feb. 29 email to staff. “Liz has been serving as Acting Chief Counsel since August 2011, and we have been grateful for her hard work and dedication each day that she has been on the job,” Hamburg said. “It is terrific to know that she will be serving the agency in this role permanently as we move forward.”

Dickinson To Deal With Biosimilars, Drug Approval Standards, Off-Label Regs

Dickinson joined the Office of the Chief Counsel in 1994 and has served as legal counsel to the Center for Drug Evaluation and Research and the Office of the Commissioner on innovator and generic drug review issues, orphan drug development and biosimilars. Hamburg noted that she has implemented pediatric exclusivity and pediatric drug development programs and worked closely with the Department of Justice on dozens of cases addressing Hatch-Waxman issues and preemption.

Dickinson “will be a sage counsel as the agency tries to make sure it is striking the right balance between risk-benefit and access and evidence,” Sidley Austin partner Coleen Klasmeier said.

Dickinson is taking the OCC helm at a key moment in the agency’s history as it implements the biosimilars legislation. Another issue confronting the agency involves potential changes to its drug approval standards. Last month, Sen. Kay Hagan, D-N.C., introduced the TREAT Act, which encourages use of the accelerated approval pathway. The legislation, Transforming the Regulatory Environment to Accelerate Access to Treatments, may be incorporated into the Prescription Drug User Fee Act reauthorization bill, which must be passed this year Also see "TREAT Act Wants Accelerated Approval Change, But Uses Existing Language" - Pink Sheet, 20 February, 2012..

Over the past few months CDER Director Janet Woodcock has also addressed calls for a “staged approval” of drugs. Speaking on a television show in January, she said the concept is feasible but suggested that the less evidence of a drug’s efficacy, the less access there should be Also see "Accelerated Approval Could Expand As Alternative To Progressive Approval" - Pink Sheet, 23 January, 2012.. Woodcock expounded on the issue in a commentary in the March issue of Nature, entitled “Evidence vs. Access: Can Twenty-First Century Drug Regulation Refine the Tradeoffs?”

Dickinson “will be a sage counsel as the agency tries to make sure it is striking the right balance between risk-benefit and access and evidence,” Klasmeier said.

Alan Bennett, a partner at Ropes & Gray who was an FDA associate chief counsel in the 1970s, said the next year will be very active in off-label regulations between court cases and other activities going on at the agency and it will be valuable to have someone who knows the agency as chief counsel. Dickinson is a “terrific selection,” he said.

Dickinson will also oversee a variety of enforcement actions and numerous lawsuits against the agency, particularly with regard to First Amendment issues and the potential fallout from a district court decision that FDA’s requirement that cigarette packaging include graphic warnings is unconstitutional Also see "Labeling Regs Feel Ripple Effects From FDA’s Capsized Cigarette Warnings" - Pink Sheet, 5 March, 2012..

FDA Looks Inside For Chief Counsel, Taps Elizabeth Dickinson

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