PhRMA's Senior Management Team: Industry Experience with Cajun Seasoning

The people behind the new Pharmaceutical Research & Manufacturers of America under former House Energy & Commerce Committee Chairman Billy Tauzin, and the appointees on PhRMA's independent direct-to-consumer advertising review panel.

The Pharmaceutical Research & Manufacturers of America has a reputation as a formidable advocate for drug companies. But the passage of the Medicare drug program—followed by a major staff changeover—made the past few years a bit tumultuous for PhRMA. With former House Energy & Commerce Committee Chairman Billy Tauzin and a core of his Louisiana aides adding political spice to a group of drug industry experts, the association is settling into a new character.

The Pharmaceutical Research & Manufacturers of America is the prescription drug industry’s largest lobbying group in the United States. PhRMA protects three pillars of the drug industry: (1) broad patient access to safe and effective medicines through a free market, without price controls; (2) strong intellectual property incentives, and; (3) transparent, efficient regulation and a free flow of information to patients.

While PhRMA remains a formidable force in Washington DC, membership has declined as the industry consolidates. The current total of 33 member companies is down from 40 companies in 1998. Membership is roughly split between US-based manufacturers (18) and overseas companies (15).

PhRMA has done a good job attracting the top tier of biotech companies with a few notable exceptions, including Genentech Inc. and Biogen-Idec Inc. (Genentech gave up its PhRMA membership in 2001 and is tangentially represented through its affiliation with Roche .)

Despite a major legislative victory with the enactment of the Medicare Modernization Act, PhRMA has faced some challenges in recent year. The industry’s sagging public image—stemming from drug pricing and risqué direct-to-consumer advertising—ranks it alongside the tobacco industry in terms of popularity. One sign of the extent of the image problem: PhRMA’s public relations staff was in constant turmoil, with five heads of the communications department within six years.

But there is a new stability at the association, starting with the appointment of CEO Billy Tauzin, the former chairman of the House Energy & Commerce Committee and Republican Congressman from Louisiana.

Getting Tauzin on board was a coup for PhRMA. The association wanted a big name to succeed CEO Alan Holmer upon his retirement at the end of 2004. Holmer departed after an eight-year term at the association, capped off by the successful legislative campaign for a private Medicare outpatient drug program.

It’s part of the drug industry trade association legacy that leaders leave after shepherding through major legislation. The bruising fights involved in passing major legislative acts often create rifts that only a new management group can address. Lew Engman, the head of the association during the generic drug debate in the 1980s, left after the Hatch-Waxman Act passed in 1984.

Tauzin was PhRMA’s top choice for its next CEO, though his appointment was delayed first by charges from Democrats that his chairmanship of Energy & Commerce created a potential conflict of interest, and then when he was diagnosed with cancer. After undergoing treatment, he resumed talks with PhRMA, and was named head of the association in January 2005.

Tauzin immediately focused on ways to improve the industry’s image among patients—and his former Congressional colleagues. Under his leadership, PhRMA launched two well-received campaigns: an initiative to address concerns about the use of prescription drug advertising, and a program to call attention to pharmaceutical access programs for low-income patients.

He also moved PhRMA’s annual meeting to Washington, DC from a rotating array of vacation resorts. The association made a similar change from a social annual meeting to a serious working environment during the period of the Clinton health care reform effort in the early 1990s. Fifteen years later, the conference has recaptured—in the words of one patient advocate—the feel of a "working meeting."

W.J. "Billy" Tauzin

President and CEO

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Email: [email protected]

Tauzin was named to head PhRMA in January 2005 after a 13-term career in the House, representing the 3rd Congressional district of Louisiana. For the last four years of his tenure, Tauzin served as chairman of the Energy & Commerce Committee, which has jurisdiction over all interstate and foreign commerce, including health care and biomedical research.

While on Energy & Commerce, he was widely credited for helping the Bush Administration pass the Medicare prescription drug benefit, including the provision that health plans—not the government—would negotiate drug prices. He was first elected to the House in 1980 as a Democrat, but switched to the Republican party in 1995.

In his first year at PhRMA, he championed the adoption of DTC advertising guidelines and the Partnership for Prescription Assistance program. As a former intestinal cancer patient, he delivers a personal message in policy debates. A popular figure in his home state of Louisiana, Tauzin speaks often of the New Orleans Saints football team, Cajun cooking and the fictional bayou-based character "Boudreaux."

Tauzin received a BA from Nicholls State University and a law degree from Louisiana State University.

Christopher Singer

Chief Operating Officer

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Singer is Tauzin’s second in command and the association’s most recent hire. PhRMA had been without an operations head for a year, since the departure of Russ Bantham in April 2005. Singer is one of the pharma industry pros on the association team. He joined PhRMA May 1 from GlaxoSmithKline PLC , where he served as SVP and area director for Brazil. Singer joined GSK in 1993, and assumed responsibility for Latin America in 2004. He has worked for two other PhRMA member companies— Pfizer Inc. (director of federal government relations) and Bristol-Myers Squibb & Co. (sales representative).

Singer received his BA in economics and his MS in public health administration from Portland State University.

Caroline Loew

SVP-Scientific & Regulatory Affairs

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Loew leads domestic and international drug development and regulatory policy programs for PhRMA, including International Conference on Harmonization activities. She joined PhRMA in 1999 as head of international regulatory affairs from Astra (now AstraZeneca PLC ), where she served as a drug development project manager. Before joining Astra, Loew worked as a development chemist at Abbott Laboratories Inc. , including international project management in the chemistry, manufacturing & controls area for the company’s protease inhibitor clinical program.

She received a BS and PhD at Imperial College in London.

Alan Gilbert

SVP-Federal Affairs

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Email: [email protected]

Gilbert is the head of PhRMA’s lobbying shop. He succeeded David Mohler, who left PhRMA in January 2006 for the law offices of Foley, Hoag & Eliot (Washington, DC) as counsel in the life sciences and governmental strategies practices. Gilbert joined the association in May 2005 from the White House, where he was President Bush’s special assistant for domestic health policy. He was a member of the White House Domestic Policy Council for three years, during which time he ledmany of the President’s health policy initiatives—medical liability reform,health insurance reform, and the uninsured.

Prior to his service at the White House,Gilbert worked as deputy assistant secretary for legislation under then-Health & Human Services Secretary Tommy Thompson.He alsoserved for five years in the Senate as chief health counsel to Senator Judd Gregg (R-N.H.) on theSenate Health Committee. Gilbert earned his BS and law degrees from Louisiana State University.

Kurt Malmgren

SVP-Government Affairs

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Malmgren is the senior member of the staff by term of affiliation with PhRMA. He joined PhRMA in 1995 as VP-state government affairs and was promoted to his current position in 1999, when the association combined federal and state affairs into a single position.

Before joining PhRMA, Malmgren was SVP for the Tobacco Institute’s state activities division, and client service manager for a California-based government relations firm. He also spent 22 years at Bethlehem Steel; among his titles were regional manager of state government affairs and manager of federal government affairs. Malmgren earned his undergraduate degree from the University of Rhode Island.

Rick Smith

SVP-Policy, Research & Strategic Planning

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Smith has been the head of policy at PhRMA since September 2001. In 2003, he added the title of strategic communications after Mark Merritt left PhRMA to become CEO of the Pharmaceutical Care Management Association. Smith was named to his current position in early 2004.

Smith worked at a number of health care associations before joining PhRMA, including the American Association of Health Plans (VP-public policy and research), the Association of Private Pension and Welfare Plans (VP-health policy), and the Washington Business Group on Health (director-public policy). He was also staff director of theMaryland Governor’s Commission on Health Care Policy and Financing.

He holds a law degree from the University of Maryland, an MA in political science from Johns Hopkins University and a BA from Wesleyan University.

Wes Metheny

SVP-Alliance, Affordability & Access

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Metheny leads an effort to develop and implement initiatives to improve patient access to prescription drugs. In this role, he oversaw the 2005 launch of the Partnership for Prescription Assistance, a central database of industry-sponsored prescription drug assistance programs for low-income patients. PhRMA adopted the themes of "access" and "affordability" as Congress was wrapping up debate on the Medicare drug benefit. Metheny received a bachelor’s degree from the University of Maryland.

Conan Grames

SVP-General Counsel

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After Singer, Grames is the next-newest member of PhRMA’s senior management team, having joined the association in February 2006 as general counsel. Early in his career, he worked in the Tokyo office of Baker & McKenzie, and joined the Bristol-Myers Company as VP and counsel for the Asia division 1982. When Bristol-Myers and Squibb merged in 1990, Grames was named VP and senior counsel of the company’s international business.

He took early retirement from Bristol in 1999 and served as a volunteer for his church in Japan until 2002. Upon returning to Utah in 2003, Grames joined the law firm of Kirton & McConkie and became chair of the International Law Section and the Health Sciences Practice Group in 2004. Grames received a degree in economics from the University of Utah in 1972 and a law degree at Harvard in 1975.

Mimi Simoneaux Kneuer

SVP-External Affairs

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Kneuer is Tauzin’s former chief of staff on the House Energy & Commerce Committee, and one of two long-time Capitol Hill aids Tauzin brought with him to PhRMA. Kneuer first worked for Tauzin as his top legislative aid on the House Subcommittee on Telecommunications, Trade & Consumer Protection in 1991. She then consulted for Clark & Weinstock and later spent a year as director of policy and government affairs for Verisign/Network Solutions. Kneuer returned to the Hill after Tauzin became chairman of the House Energy and Commerce Committee.

She holds a BA in international relations from Tulane University.

Ken Johnson

SVP-Communications

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Johnson served as Tauzin’s head of communications and deputy chief of staff on the House Energy & Commerce Committee. After Tauzin stepped down as chair of the committee, Johnson completed a short stint as chief spokesman and communications director at the Department of Homeland Security, under then-Secretary Tom Ridge. He joined PhRMA with his former boss in early 2005. Among Johnson’s recruits are Arturo Silva, who was deputy press secretary at Energy & Commerce, and Jennifer Page, the former press secretary at Homeland Security.

Before Capitol Hill, Johnson was a news director, anchor and political reporter for CBS-TV affiliates. He graduated from Knox College and received an MS from the College of St. Francis.

Industry’s Guardians of DTC Advertising

It took longer than PhRMA hoped, but the association recently appointed an independent review panel to monitor compliance with the drug industry’s voluntary "guiding principles" for direct-to-consumer advertising. The four-person committee is made up entirely of health care professionals and will deliver a report on DTC in early 2007.

The drug industry’s consumer advertising watchdog committee is the final piece of a self-regulation initiative PhRMA started in 2005 to address growing concerns about the content and use of DTC advertising. (See "DTC Loses Powerful Friends, Will PhRMA Bring Them Back?" The RPM Report, December 2005 (Also see "DTC Loses Powerful Friends, Will PhRMA Bring Them Back?" - Pink Sheet, 1 Dec, 2005.).)

The board will review compliance with PhRMA’s DTC Guiding Principles, which formally went into effect for most member companies in early 2006. The principles advocate a ban on "reminder ads"; a moratorium on DTC advertising for new products; direct communication of benefit and risk; and age-appropriate airing of TV commercials.

The effort has mollified some critics of DTC advertising and staved off efforts on Capitol Hill to further regulate the practice. (See "The New Economics of DTC: Responsibility Sells," The RPM Report, April 2006 (Also see "The New Economics of DTC: Responsibility Sells" - Pink Sheet, 1 Apr, 2006.).)

The self-policing initiative is well timed. If PhRMA’s self-regulating tactics continue to work, the industry could take DTC off the table as an issue during the reauthorization of the Prescription Drug User Fee Act. (See "Time to Pay the Piper? Industry Prepares for a Fight over User Fees," The RPM Report, May 2005 (Also see "Drug Safety Reform: Did FDA Buy Time or Trouble?" - Pink Sheet, 1 Apr, 2006.).)

In staffing the committee, PhRMA walked a careful line: members needed to be credible for the self-regulatory process to work, but not openly critical of DTC advertising.

The four members—Lawrence Brown, James Jones, Nancy Sharp and Lucille Perez—are used to working in professional societies, where finding a consensus among many stakeholders is an important attribute. All members on the committee are health care providers: two are practicing physicians, one is a pharmacist and one is a nurse.

The panel plans to work within a "grid" system to compare the PhRMA principles to current print and television advertising campaigns. The group is planning a series of conference calls over the summer and will come together in October to start writing a final report, to be submitted to PhRMA and the Food & Drug Administration in early 2007.

PhRMA’s committee will work independently of FDA’s advertising regulatory group, the Division of Drug Marketing, Advertising & Communications. (See "FDA’s Consumer Ad Watchdogs," The RPM Report, March 2006 (Also see "FDA's Consumer Ad Watchdogs" - Pink Sheet, 1 Apr, 2006.).)

Lawrence "LB" Brown

Chairman of DTC panel

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Brown is an assistant professor of health science administration in the department of pharmaceutical sciences at the University of Tennessee. His research interests include quality assurance of pharmaceutical care practitioners, eliminating health disparities, medication adherence and society’s perception of pharmacists in TV, films and fictional novels.

Brown is the former speaker of the American Pharmacists Association House of Delegates. He completed his Pharm.D. at the University of the Pacific and his doctorate in social and administrative pharmacy at the University of Minnesota. He began his pharmacy career as a U.S. Air Force pharmacy technician in 1985.

James G. Jones

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Jones is a professor and chairman emeritus in the department of family medicine at East Carolina University School of Medicine. He now works as a pediatrician at the Maple Hill Medical Center in Maple Hill, NC, and believes his daily interaction with patients is what made PhRMA select him for the committee.

Jones is the former president of the organization that became the American Academy of Family Physicians. He received his BS at Wake Forest College in 1955 and his MD degree at Bowman Gray School of Medicine in 1959.

Nancy Sharp

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Email:[email protected]

Sharp is a founding executive director of the American College of Nurse Practitioners, and served at the organization from 1993-1997. She has worked as a legislative and policy consultant for a number of nurse specialty organizations including ACNP and the American Nephrology Nurses Association.

Sharp says her experience at ACNP and with individual nurse fractionizes will be the most relevant to her work on the panel. One of the criticisms nurses have with DTC advertising, she says, is that many of the ads only state that "doctors" are prescribers, when, in fact, other health care professionals—like physician assistants and advance practice nurses—can write prescriptions.

She is now heads her Bethesda, MD-based consulting group, Sharp Associates.

Lucille Perez

Perez is a past president of the National Medical Association. During her tenure, NMA released a survey on African-American physicians’ perception of direct-to-consumer advertising. Physicians reported an overall favorable impression of DTC ads, and NMA called on the drug industry to place more ads in traditionally African-American media outlets.

Perez also served as national health director in the health advocacy division of the NAACP and as associate director of the Center for Substance Abuse and Prevention at HHS’ Substance Abuse and Mental Health Services Administration.

She received her medical degree from New York Medical College.