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Executive Summary

Sen. Kennedy's Labor & Human Resources Committee staff will more than double to 15-20 staffers, from the seven who served on the minority staff, in the wake of his decision to chair the committee with jurisdiction over health policy. The Massachusetts Democrat's committee staffers are currently led by Thomas Rollins, who is expected to continue as staff director and chief counsel. Rollins does not describe oversight as his prime interest; he says he is more inclined to enactment of legislation. Rollins will be joined on Kennedy's staff by David Nexon, PhD, and Mona Sarfaty, MD. Nexon, senior health policy adviser on the minority staff, worked on Medicare and Medicaid issues at the Office of Management & Budget during the Carter and early Reagan Administrations. Safarty, health policy adviser last year, is a physician who worked extensively on drug export legislation for Kennedy. The staff is saying Kennedy's goals will be to produce "budget-conscious legislation" and to enable the federal government to complement and coordinate private sector efforts in biomedical research. The senator wants to "send a message to the Japanese that they will not do in biotechnology what they did with semiconductors," Rollins said. The Labor & Human Resources Committee will join with three Democrat-controlled health-related committees in the House in setting the Capitol Hill agenda for health care in the 100th Congress. Kennedy chose to chair the Senate health panel rather than the Judiciary Committee and announced his choice at a Nov. 8 press conference in Boston. The new chairman's major health policy interests include improving the access of underinsured people to health care services and supporting disease prevention and health promotion strategies. Kennedy's cosponsorship of the "Improved Access to Health Care Initiative," a bill which did not pass the 99th Congress, provides an example of one type of legislation he will pursue. Funding of basic health research is another priority for Kennedy. He reportedly views biomedical research as related to the overall social goal of economic development insofar as basic research leads to new product development, which in turn generates employment opportunities and improves the international competitive position of the U.S. Massachusetts has become a center of biotechnology research and industry and Kennedy will be sensitive to the position of that health care segment. Biotechnology was not a developed field when the senator last chaired the Labor & Human Resources Committee and its highly pulicized oversight hearings involving FDA and the pharmaceutical industry. The development of biotechnology, and Massachusetts as one of its major locales could indicate that the style of Kennedy's chairmanship of the committee will be moderated. In the House, the Energy & Commerce Committee, its Health Subcommittee, and the Government Operations/Intergovernmental Relations Subcommittee remain key to legislation affecting the pharmaceutical industry. As chairman of both the Energy & Commerce Committee and its Oversight & Investigations Subcommittee, Rep. Dingell (D-Mich.) has considerable staff support. On the full committee staff, Lesley Russell has worked on hearings regarding biotechnology. The majority of Dingell's efforts that affect the pharmaceutical industry is conducted on the subcommittee level. Key staffers on the Oversight Subcommittee include Chief Counsel/Staff Director Michael Barrett, lawyers Benjamin Fisherow and Patrick McLain, Economist David Nelson and Special Assistant Stephen Sims. Nelson and Sims have focused most of their energies over the past two years investigating drug diversion and counterfeiting. Since Rep. Waxman (D-Calif.) assumed control of the Health Subcommittee in 1981, the panel has developed more legislative proposals affecting the industry than any other single congressional committee. Waxman's staffers are headed by Staff Director Karen Nelson and include Counsels Robert Adler, Peter Budetti, William Corr, Ruth Katz, and Timothy Westmoreland and Staff Associate E. Ripley Forbes. The Intergovernmental Relations Subcommittee over the years has held numerous oversight hearings that have focused on FDA approval decisions. In 1982, former Rep. Fountain (D-N.C.) chaired hearings to review agency approvals of Oraflex and Feldene. The hearings led to the regulatory requirement that adverse effects reported under INDs be submitted to pending NDAs. Since Fountain resigned from Congress, Rep. Weiss (D-N.Y.) has continued vigilant oversight of FDA activities. Hearings have focused on FDA's regulatory handling of E-Ferol and color additives and the approvals of Zomax and Merital. FDAers say that they expect a follow-up hearing on Merital and that future hearings could involve Suprol and Wellbutrin. Other oversight activities have included correspondence questioning FDA about issues such as color additive regulation, former Com. Hayes' honoraria, and Com. Young's contract with John Norris before Norris was named deputy commissioner. Weiss' key aide in these efforts has been Daniel Sigelman.

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