House Credit for FDAAA

Key House staffers on the Food & Drug Administration Amendments of 2007 are identified. Key negotiators for FDA and the biotech industry on the failed follow-on biologics effort are also identified.

When the House finished work on the Food & Drug Administration Amendments Act on Sept. 19, the leadership doled out praise to staffers who worked on the final compromises. Less effusive than the Senate five months earlier, the number of staff receiving public praise was smaller. (See "Senate Drug Safety Experts" "The RPM Report, July 2007 (Also see "Leads and Contacts--July 2007" - Pink Sheet, 1 Jul, 2007.).) Some of the personal stories were equally revealing: at least two weddings; one staffer who was married during the negotiations and spent the first months of married life, married to the bill; and a staffer who was praised for working all night on Sept. 18 and was still dressed in the same clothes on the day the bill passed.

Democratic Staff

Warren Burke

Assistant counsel, Office of Legislative Counsel

Phone: [phone]

E-mail: [email protected]

John Ford

Majority Counsel, House Energy & Commerce Committee, Health Subcommittee

Phone: [phone]

E-mail [email protected]

Virgil Miller

Professional staff member, House Energy & Commerce Committee

Phone: [phone]

Pete Goodloe

Legislative counsel, House Energy & Commerce Committee

Phone: [phone]

Bobby Clark

Policy coordinator, House Energy & Commerce Committee, Health Subommittee

Phone: [phone]

Karen Nelson

Health policy director, Henry Waxman (D-CA.)

Phone: [phone]

E-mail [email protected]

Rachel Sher

Health counsel, Henry Waxman (D-CA.)

Phone: [phone]

E-mail: [email protected]

Stephen Cha, MD

Professional staff member, House Committee on Oversight & Government Reform

Phone: [phone]

E-mail: [email protected]

Health Counsel, House Committee on Oversight & Government Reform

Phone: [phone]:

Jennifer Nieto Carey

Recently left position as health legislative assistant to Anna Eshoo (D-CA.)

Mark Bayer

Legislative director, Edward Markey (D-MA.)

Phone:[phone]

E-mail: [email protected]

Handled work on privacy issues.

Republican Staff

Ryan Long

Minority counsel, House Energy & Commerce Committee, Health Subcommittee

Phone: [phone]

E-mail: [email protected]

Nandan Kenkeremath

Minority counsel, House Energy & Commerce Committee, Health Subcommittee

Phone: [phone]

John Little

Legislative assistant, Nathan Deal (R-GA.)

Phone: [phone]

E-mail: [email protected]

FOB Negotiators and Massachusetts’ Biotech Muscle

The Massachusetts Biotech Council has found it hard to avoid controversy. The trade group, which represents over 500 primarily small biotech companies and academic institutions in the state, has been making headlines of late. In January, the former head of the organization pled guilty to one charge of obstruction in a deal that cleared him of perjury charges while he was the state’s House Speaker. His replacement, Robert Coughlin, came under fire at the end of August from charges that he negotiated his current job while he was still working on biotech initiatives as a top aide to Governor Deval Patrick. Behind the headlines, however, MBC played a key role in negotiating the near-miss follow-on biologics legislation that failed to make it into the FDA Amendments Act. (See "Flubbing the FOBs Opportunity: Follow-on Biologics Winners & Losers" in this issue (Also see "Flubbing the FOBs Opportunity: Follow-on Biologics Winners & Losers" - Pink Sheet, 1 Oct, 2007.).)

From FDA, Stephen Mason, Jane Axelrod and Janet Woodcock were considered invaluable during the negotiation process as advisors to Congressional leadership, House and Senate staffers say. The biotech and generic industries reportedly sent in a team made up primarily of outside lawyers with strong ties to companies to negotiate the compromise.

Mass. Biotech Council

Robert Coughlin

President

Phone: [phone]

Email: [email protected]

Mark Robinson

Chief Operating Officer

Phone: [phone]

Email: [email protected]

John Lacey

Director of Communications

Phone: [phone]

Email: [email protected]

Stephen Mulloney

Director, Policy & Public Affairs

Phone: [phone]

Email: [email protected]

FDA Advisors

Janet Woodcock

Chief Medical Officer

Phone: [phone]

Email: [email protected]

Jane Axelrod

Director, Office of Regulatory Policy

Phone: [phone]

Email: [email protected]

Stephen Mason

Senior Advisor, Office of Legislation

Phone: [phone]

Email: [email protected]

Industry Negotiators

Jeffrey Kushan

Partner, Sidley Austin Brown & Wood

Phone: [phone]

Email: [email protected]

Christine Siwik

Partner, Rackozy Molino Mazochy Siwik

Phone: [phone]

Email: [email protected]

Bill Schultz

Partner, Zuckerman Spaeder

Phone: [phone]

Email: [email protected]

Kay Holcombe

Senior policy advisor, Genzyme

Phone: [phone]

Email: [email protected]