FDA INDEPENDENCE MOVEMENT HAS GROWING SUPPORT IN HOUSE HEALTH SUBCOMMITTEE: DEMOCRATS BRUCE AND SIKORSKI JOIN GROUP IN FAVOR OF BREAKING AGENCY OUT OF PHS

Support for breaking FDA out of the Public Health Service is growing on Capitol Hill in response to the report of the Edwards Committee. At a June 12 hearing before the House Health Subcommittee, two congressmen who had not previously spoken out on the subject of FDA's organizational status lent their support to a change within HHS. The June 12 hearing was designed as a forum for introducing the main recommendations of the Edwards Committee report. The House hearing mirrored a previous discussion of the report before the Senate Labor & Human Resources Committee ("The Pink Sheet" May 20, p. 9). Rep. Sikorski (D-Minn.) and Rep. Bruce (D-Ill.) joined Health Subcommittee Chairman Waxman (D-Calif.) in supporting the call for semi-autonomous status for FDA within HHS. Subcommittee making minority member Bliley (R-Va.) appeared close to accepting the idea of independence. "I have reviewed the recommendations contained in the [Edwards] report, and it is interesting to note that one calls for the removal of the FDA from the Public Health Service or the establishment of the FDA as a free-standing agency," Bliley stated. "While I am willing to give Commissioner Kessler the time he needs to establish institutional reforms, I would not be averse to exploring all possibilities to ensure the FDA acts most efficiently." Sikorski stated that after "seeing what's happened in medical devices and drugs and generics and food and pesticides and the rest of it over the years . . . I'm pretty attracted to the idea of making the agency completely independent." Sikorski added that the subcommittee is concerned that "an agency living in the shadows of another superagency, whose regulations are subject to review, whose personnel are subject to review, whose budget is subject to review," will foster duplication of policies and provide "backdoor opportunity" for practices that are not in the public interest. Charles Edwards, MD, president of the Scripps Clinic and chairman of the advisory committee which studied the agency, recommended in testimony to the June 12 hearing that the FDA commissioner "report directly to the Secretary, not through a bureaucratic maze that has proved over the years to be more hindrance than help." Urging Congress to force HHS into granting automony to the agency, Edwards asked that legislation be enacted to reconstitute the agency "as a free-standing Executive Branch organization along the lines of the Environmental Protection Agency" if the Administration is unwilling to separate FDA from PHS. The developing support in the House comes on top of Sen. Kennedy's (D-Mass.) statement a month ago that he would consider a bill to grant the agency more independence. Capital Hill's interest in the recommended organizational change for FDA appears to stem from two points: it gives Congress a chance to respond in an uncomplicated manner, and without having to come up with new funding, to the damaged image of the agency; and it would make the FDA commissioner more directly responsible for actions or inactions at the agency. By making the commissioner more responsible and taking away the layers of PHS management above, a structural change would fit with the recently added requirement that the commissioner needs Senate confirmation. HHS Secretary Sullivan continues to argue against a change in FDA's status within the PHS. "I do not believe the location of the agency is the source of FDA problems," Sullivan declared, adding that "being in the PHS does not inhibit the [FDA] commissioner's access to department officials." Instead, Sullivan contended, "what we need are adequate resources for the FDA." The secretary said "you can draw the charts, have reporting lines whatever way you like, but if the commissioner doesn't have the resources, whether he's part of the Public Health Service or independent of the Public Health Service or independent of the Department of Health and Human Services," he will be unable to carry out FDA's tasks. In response to a series of questions posed by Rep. Bruce, Sullivan argued that removing FDA from PHS would weaken its "scientific base" because such action would impede the "organic" and "necessary" collaboration FDA conducts with other PHS agencies like the National Institutes of Health and the Centers for Disease Control. As an example, Sullivan noted that interaction between PHS and the Health Care Financing Administration, which is separate from PHS, "requires a lot more energy level than does interaction between, say, NIH and FDA or CDC." Sullivan also predicted that FDA's removal from PHS would require "a negotiating process, memoranda of understanding, and a much more complex bureaucratic way of resolving disputes . . . so that in my view, what we would be doing in effect is erecting a barrier between the FDA and the Public Health Service rather than facilitating the work of the FDA and the interacting with the other components of the Public Health Service." Edwards asserted that though he was not "anti-PHS," he believes "it's critically important" to remove FDA from PHS. He predicted that recreating FDA as a stand-alone agency would endow FDA's commissioner with "the prestige and the status that goes with having enormous responsibility." If you push [FDA] down three layers deep within the HHS, it obviously doesn't lend itself . . . to this element of prestige and the ability to really deal effectively with industry," Edwards said. Edwards Committee member Richard Merrill, a professor of law at the University of Virginia and a former chief counsel of FDA, added that his interest in locating FDA outside PHS derived from his concern that the agency currently is dependent on the caliber of its commissioner for proper functioning: "I think the present system can work adequately, not well, if you have a brilliant commissioner, like we now have. Without a brilliant commissioner," he stated, "I think it will not work well at all." Committee member Frank Samuel, previously president of the Health Industry Manufacturers Association and currently a governmental affairs consultant in Washington, D.C., stated that the location of FDA within PHS "is an impediment" to the effectiveness of the agency. He questioned, for example, "the value of the commissioner having to have two one-on-one sessions with two bosses [the assistant secretary of health at HHS and Secretary Sullivan]" or "having to go to the Public Health Service . . . and then to the Office of the Secretary in order to go to the Office of Personnel Management to get unallocated [senior executive service] positions." Sullivan cited a recent change in the commissioner's top deputies as an example of how quickly a request from FDA can be approved through the HHS hierarchy. Noting that Kessler first formally asked for the new deputy positions on April 8, Sullivan reported that the change was approved by HHS eight weeks later on June 7 (see T&G-9). Waxman was skeptical of the eight-week turnaround, asking whether the two-month period adequately reflected the amount of time it actually took for Commissioner Kessler to get his top staff structure aligned. Questioned by Waxman, Sullivan acknowledged that Kessler had mentioned the idea of creating five top positions to report directly to him at one of the regular one- on-one meetings between the FDA chief and the HHS secretary earlier in the year. The staff positions approved June 7 include four deputy commissioner positions and one senior advisor position. Sullivan said the positions have been created to reduce the number of people reporting directly to Kessler and to permit the commissioner to devote more time to an overview of FDA issues and policy.