FDA Chief Counsel Bradshaw Brings DoJ Experience, Utah Political Ties

Incoming FDA Chief Counsel Sheldon Bradshaw brings high-level government experience and strong political connections to the agency's top legal post.

HHS General Counsel Alex Azar appointed Bradshaw to the official post of associate general counsel of the Food & Drug Division of the HHS Office of the General Counsel on April 1. He will head up FDA's Office of Chief Counsel.

Bradshaw, who will join the agency April 18, becomes the permanent successor to former Chief Counsel Daniel Troy. Gerald Masoudi has served in the role on an interim basis since Troy's Nov. 24 departure (¹ (Also see "FDA Chief Counsel Troy Resigns; Agency Says It Will Still Support Preemption" - Pink Sheet, 22 Nov, 2004.), p. 15).

Bradshaw comes to FDA from the Justice Department, where he most recently served as principal deputy assistant attorney general in the Civil Rights Division. He previously worked as deputy assistant AG in the Office of Legal Counsel.

His DoJ tenure included work on such health-related issues as generic drug reforms and assisted suicide.

In August 2003, Bradshaw testified before the Senate Judiciary Committee on generic drug reforms contained in the Senate's version of the Medicare prescription drug benefit bill.

The Senate bill would have created an "actual controversy" between an ANDA filer and an innovator sufficient to confer federal court jurisdiction over declaratory judgment actions brought by generic companies for patent invalidity or noninfringement.

Bradshaw testified that the provision was an unconstitutional expansion of federal court jurisdiction (² , p. 15).

The Senate language was not included in the final Medicare conference bill. Rather, the final version of the Medicare Modernization Act stated that federal courts must determine whether declaratory judgment actions brought by generic companies are a "case or controversy" under the Constitution.

In January, a federal appeals court ruled the MMA did not relax the requirement that an ANDA filer demonstrate that it has a "reasonable apprehension" of being sued by the innovator in order to bring a declaratory judgment action (³ (Also see "Declaratory Judgment Ruling Will Add Uncertainty To Generic Launches" - Pink Sheet, 31 Jan, 2005.), p. 33).

The panel's ruling came in a dispute between Teva and Pfizer over a Zoloft (sertraline) patent. On April 4, the full appellate court declined to rehear the case.

Bradshaw also was involved in the government's challenge to Oregon's assisted suicide law. In June 2001, he co-authored a memorandum for then-Attorney General John Ashcroft which concluded that physician-assisted suicide is not a "legitimate medical purpose" under the Controlled Substances Act.

The memorandum served as the legal basis for Ashcroft's November 2001 directive, which stated that prescribing, dispensing or administering federally controlled substances to assist suicide violates the CSA, according to court filings.

Bradshaw is a graduate of Brigham Young University, and he is understood to have extensive connections throughout the Utah political establishment.

His appointment to the FDA post comes two months after former Utah Gov. Michael Leavitt took over as HHS Secretary (⁴ , p. 3).

Bradshaw's wife, Corine, is currently on leave from her staff position in Utah Republican Sen. Robert Bennett's office. She was named legislative director for Bennett in April 2001.

Bennett is chairman of the Appropriations Committee/Subcommittee on Agriculture, which has appropriations oversight for FDA.

Bradshaw also has ties to Sen. Orrin Hatch (R-Utah), for whom his wife formerly worked. Hatch is chairing the Senate Judiciary Committee's new Intellectual Property Subcommittee (⁵ 'The Pink Sheet' March 21, 2005, In Brief).

Prior to joining DoJ, Bradshaw practiced law in the D.C. office of Howrey Simon Arnold & White. He earned his law degree from George Washington University.

Masoudi, who joined the agency in November as deputy chief counsel, will return to that position (⁶ (Also see "FDA Deputy Chief Counsel Masoudi Brings Antitrust Law Background To Post" - Pink Sheet, 15 Nov, 2004.), p. 12).