FDA COUNCIL FORMED TO SEEK FDA FUNDING INCREASES, PARTICULARLY IN DRUG REVIEW; CONGRESSIONAL HEARINGS ON FDA FUNDING SHORTFALL ENVISIONED

Seven drug companies are working with the American Medical Association on an independent lobbying effort in Washington to seek greater funding and resources for FDA. The vehicle for the lobbying effort is a new Washington organization called the FDA Council. The council describes itself as "an advocacy program of lay, professional and industry groups... with the sole, nonpartisan purpose of advocating in the Administration and Congress for the FDA." It began the lobbying effort about five months ago. In addition to the AMA, the members of the council are Alza, Genentech, Merck, the National Organization for Rare Disorders, Pfizer, Sandoz, Squibb, and Upjohn. The council's specific goals are to increase funding for salaries for top agency officials and other personnel, training programs, visiting scientific advisors, communication systems, space requirements, and equipment and instrumentation. The council says it plans to "work with the Administration and the Congress to bring the FDA infrastructure in line with other R&D agencies to expedite the application of scientific advances in the clinical arena and restore the program balance for the FDA as it relates to other federal agencies." For example, the Office of Management and Budget reportedly has proposed cutting FDA's budget to $377 mil. in fiscal 1990 from $536 mil. in 1989. At the same time, OMB is proposing an increase in funding for the National Institutes of Health. One of the council's initial objectives was realized late in the just-ended congressional session in the form of a Senate request for a Government Accounting Office (GAO) study of FDA resource and infrastructure needs. GAO has been asked by Senators Burdick (D-N.D.), Kennedy (D-Mass.), Cochran (R-Miss.) and Hatch (R-Utah) to report back by mid-February 1989 on such issues as the advisability of setting up a special employment class for senior biomedical staff at FDA and computer needs at the agency ("The Pink Sheet" Nov. 7, T&G-2). The staffing suggestions build on a task force report prepared by FDA with the assistance of the Pharmaceutical Manufacturers Association in mid-summer. Hatch put his imprimatur on a plan to increase funding at FDA with an FDA revitaliation bill introduced in June ("The Pink Sheet" June 13, T&G-1). Although the bill did not pass last year, Hatch did get important support in his effort from Kennedy, and several key provisions were incorporated into fiscal 1989 appropriations legislation. As a logical follow-up to the GAO report, congressional hearings may be set in 1989 on FDA resource needs. The convening of oversight hearings "early in the first session of the 101st Congress" is one of the council's next objectives. In addition, the council plans to develop an "advocacy budget," a brochure and other public relations and government relations materials. It also plans to prepare legislative packages for the Senate committees on the Budget, Appropriations, Labor & Human Resources, and Government Affairs; and for the House committees on the Budget, Appropriations and Energy & Commerce, and the House Intergovernmental Relations Subcommittee. As part of its public relations effort, the council has had several outside speakers on resource issues. Recently, FDA Com. Young spoke to a council meeting on the topic. The group is headed by Terry Lierman of Capitol Associates, a Washington, D.C. lobbying firm. Lierman, who holds the title of president of the Council, is a former staff director of the Senate Appropriations Committee. The council says FDA, the pharmaceutical industry, health professionals, and volunteer organizations must "take the necessary steps to ensure that the FDA is supported in such a way that it can achieve its mission in a timely and efficient manner." At its current funding levels, FDA "can no longer keep pace with the volume of products" that it must review and regulate, the council maintains. The agency's 1989 budget appropriations for drugs and biologics is set at $187 mil. "The resources necessary to meet the needs of our rapidly accelerating research enterprise include personnel, training program resources, space, instrumentation and equipment, and research facilities," the council states. The physical facility needs at FDA are some of the most pressing needs. The agency is currently spread out among almost two dozen buildings at five different sites in the Washington area. Although the 1989 FDA budget shows an increase in funding for buildings, the bulk of the increase is devoted to a new AIDS facility planned for the NIH campus. In actuality, the 1989 budget could exacerbate the agency's space problems by cutting back on the amount available for repairs and renovations on exisitng facilities. One approach to the FDA space needs which has been floated several times during this decade is the possibility of using non-governmental funds to provide FDA with new space. That idea is obviously suspect to conflict of interest attacks if the funds derive exclusively from FDA-regulated industries. However, if the coalition providing funds were broad enough and encompassed consumer and professional groups as well as representatives of regulated industries, it might offer a fall-back approach to governmental funding for facilities. One of the potential pitfalls of the current lobbying for FDA funds in Washington is the proliferation of different and overlapping groups seeking help for the agency. The council describes its work, with an emphasis on appropriations, as complementary to other organized efforts to aid FDA in its mission. However, at least two key PMA member firms which have been active in the FDA improvement effort are notably missing from the current council sponsors. The coordination between the council and PMA efforts could improve in 1989 when Merck's Vice Chairman John Lyons is set to become the association chairman. Merck is a member of the council. PMA has been very active for four years in the area of FDA improvement through a special board committee. Chaired by Roche President Irwin Lerner, the committee has focused predominantly on technical approaches. They have included streamlining FDA review procedures, the use of communications technology in preparing applications, and use of the Institute of Medicine and other outside advisors to share FDA's IND and NDA review burden. Another body interested in agency funding is the Industrial Biotechnology Association's FDA Liaison Committee, which met with Commissioner Young on Dec. 6 and pledged its assistance in the efforts to increase agency resources. The IBA committee comprises board members representing CEOs of Amgen, Colgene, Centocor, Cetus, Genentech, and Immunex. The council is distinct from the FDA Coalition, initiated last summer with the long-range goal of locating the agency in a single facility. Composed of a group of professional and trade organizations rather than industry groups, the coalition hopes to arrange for the construction of a centralized FDA facility on the campus of the Uniformed Services University for the Health Sciences. Young reportedly considers the location, across the street from the National Institutes of Health, a key to attracting top-notch scientific talent to the agency.