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FDA BLUE RIBBON COMMISSION MEMBERS INCLUDE FORMER KENNEDY STAFFER HOROWITZ, FORMER HATCH STAFFER KESSLER AND MYLAN CEO PUSKAR; FIRST MEETING IN MAY

Executive Summary

Former Kennedy health staffer Lawrence Horowitz, MD, and Mylan President Milan Puskar are among the 15 members of the FDA blue ribbon commission, announced by HHS March 22. Horowitz was a strong Capitol Hill critic of FDA when he served as Sen. Kennedy's (D-Mass.) health staffer during the 1970s. He was on Sen. Kennedy's health staff from 1970 to 1980 and worked on the senator's hearings on pharmaceutical industry promotional practices in the mid-1970s. From 1981-1986, he served as Kennedy's chief of staff. Horowitz is currently an investment banker in California working for James D. Wolfensohn, Inc. Puskar's company was the catalyst for the overhaul of FDA's generic review process; Mylan initiated its own investigation of ANDA review practices when his complaints that some reviewers might be showing favoritism to other company's ANDAs did not spark a reaction from FDA officials. The findings of Mylan's private investigation uncovered evidence of favoritism among FDA reviewers in the generic division, which precipitated Rep. Dingell's (D-Mich.) look into FDA's ANDA approval process. * The selections of Horowitz and Puskar by HHS to sit on the FDA panel reflect the carefully balanced nature of the 15-member body. Both political parties are represented, as well as practically all industry groups regulated by FDA, elderly patients, doctors, minority concerns, and former FDAers (see chart for list of members). The panel initially was to have included only 13 members. HHS Secretary Sullivan explained that the increase in the size of the panel "is a positive development that will allow for a greater range of consumer and industry participation, as well as for a full spectrum of technical expertise." The formal appointment of members is subject to routine HHS procedures including an assessment of possible conflicts of interest. The brandname companies are represented by Syntex President and CEO Paul Freiman. As expected, the panel also includes a member of the biotechnology industry, T-Cell Sciences Chairman and CEO James Grant, along with a representative from academia, Rita Colwell, PhD, director of the Maryland Biotechnology Institute, the biotech research department of the University of Maryland. OTC and consumer products giant Procter & Gamble is represented by former company president and CEO John Smale, now chairman of the board's executive committee. Horowitz' inclusion on the panel is balanced somewhat by the nomination of David Kessler, MD, medical director of the Hospital of the Albert Einstein College of Medicine, who served on the staff of Sen. Hatch (R-Utah) from 1981 to 1984. The panel also includes Louis Lasagna, MD, Dean of the Sackler School of Graduate Biomedical Science at Tufts University. Lasagna is currently the head of an HHS expert panel set up to consider FDA approval procedures for AIDS and cancer drugs. * The panel's chairman, former FDA commissioner and now Scripps Clinic President Charles Edwards, said that he expects the inaugural meeting of the panel to be held "sometime in May." The group's meetings are expected to be public. During the month of April, Edwards said he will be working with HHS and FDA to put together the panel's agenda for the coming year. Edwards also said he will consult with the department and the agency on a list of issues for the panel to address. The group will review the mission, structure, priorities and resources of the agency and recommend what changes, if any, "can be made within the FDA to strengthen its ability to accomplish its mission." Sullivan announced his plans for the panel in December; Edwards' appointment as chairman was announced March 2 ("The Pink Sheet" March 5, T&G-1). A preliminary report from the panel is due at HHS approximately four months after the group begins its work, to be followed by a final report within one year, according to the group's charter. The commission will not "concern itself with filling the now-vacant post of FDA commissioner," HHS said. "A search committee appointed specifically for that purpose will be announced at a later date." When the idea for the panel was originally conceived, HHS reportedly considered having the group look for a new commissioner as well. A priority for the panel will be the issue of FDA resources. However, the group, selected by HHS, is unlikely to attempt to embarass the Administration by asking for large increases in FDA's budget. Edwards acknowledged he feels user fees as a concept should be considered by the panel. In addition to the panel chairman, the group also includes FDA veteran John Taylor, former associate commissioner for regulatory affairs, and Richard Merrill, former chief counsel. Taylor is currently a consultant with the Washington, D.C. firm Patton, Boggs and Blow; he left the agency in July. Merrill is a professor at the University of Virginia law school and was chief counsel at FDA from 1975 to 1977. Panelists currently or recently affiliated with industry or professional associations include: Grocery Manufacturers Association VP/Science and Technology Sherwin Gardner; former Health Industry Manufacturers Association President Frank Samuel, now a health care and medical device industry consultant; and American Medical Association President Alan Nelson, MD. Representing consumer interests are American Association of Retired Persons Director of Legislation, Research and Public Policy John Rother, and Jane Delgado, PhD, president of the National Coalition of Hispanic Health and Human Services Organizations. Delgado is a former HHS senior health policy advisor.
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