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Executive Summary

FDA independence from the Department of Health and Human Services could speed up the time it takes for regulations to be published and take politics out of scientific decisions, House Energy & Commerce/Health Subcommittee Counsel William Schultz suggested at the July 11 meeting of the Advisory Committee on FDA. Schultz said he did not "know of any advantages" to FDA being a part of HHS. "At its most benign," Schultz maintained the disadvantage of FDA's being under the HHS umbrella is the "delay" in the reg-making process. At "its most serious," Schultz continued, the disadvantage is "the interjection of politics into what ought to be principally scientific decisions and the undermining of the morale of the scientists at the FDA, who are making and defending those decisions." Schultz suggested that the Edwards Committee recommend that FDA be set up as an independent agency outside of the executive branch -- similar to the Federal Trade Commission -- in order to avoid Office of Management & Budget review and the extra management layer of HHS. "I think it is essential to work out this HHS/OMB problem," Schultz declared. "Since the [Edwards Committee] can be more wide ranging than a new commissioner," Schultz added, "you could recommend that the FDA be an independent agency. And if it's set up the way the FTC and some of the other independent agencies are ...then there is no OMB review." Schultz, one of a panel of three invited presenters to the Edwards Committee with long-term familiarity with FDA, noted that the views he expressed were his own and neither those of Rep. Waxman (D.-Calif.) nor the Public Citizen Litigation Group where he worked before moving to the Hill. "In terms of regulations I cannot think...of a single instance where HHS or OMB review has improved a regulation in a substantive way." He continued: "There are many times when it has seriously delayed regulations and there are a number of significant occasions where it has really harmed [a regulation]." Delays in issuing regulations, Schultz emphasized, cause a "real loss in public health protection." He maintained that "a lot of lives were lost because FDA was so slow" in moving some regs. As examples, he cited the length of time it took to issue labeling regulations for tampons about the risk of toxic shock syndrome and for Reye's syndrome warnings for aspirin. Another presenter, Peter Barton Hutt, a former FDA chief counsel and currently a partner with the Washington, D.C. law firm Covington & Burling, echoed Schultz' comments on the roles of HHS and OMB in the reg-making process. However, Hutt recommended that FDA "work out an accommodation with HHS and OMB." Hutt stated: "I am convinced that that can be done, even under the current reservation of authority and certainly under the current executive orders, because I don't think that executive order is going to be modified, much less repealed." The third speaker, former FDA acting commissioner and current Upjohn Exec VP Mark Novitch, MD, also agreed that establishing FDA as an independent agency would be beneficial. "The single most important thing is range of motion [and] independence of action [for the agency]," Novitch told the committee. "Under today's conditions, I would say that remaining in the PHS is nothing but a hindrance...and of course the OMB has always been a hindrance." Edwards Committee member John Taylor, a former FDA associate commissioner for regulatory affairs and currently a consultant with the Washington, D.C. law firm Patton, Boggs and Blow, agreed with the three presenters on the negative impact of HHS and OMB oversight on FDA's regulatory process. However, he expressed concern "about [FDA] being an independent agency also, because you're still going to get a lot of pressure from some of the congressional committees." The former FDAer said that oversight committees have "a very negative effect on the agency, and some of the delays have been caused by them because the agency has gotten to a point where they're afraid to make decisions because they think they're going to be second-guessed." In response to a question from the Edwards Committee on what he would do if he were FDA commissioner (see story on p. 10), Schultz said he would "look at this issue of the timeliness of regulations and...get a list of every pending regulation and devise a scheme for getting regulations promulgated within a year from start to finish, except in extraordinary circumstances." However, the Edwards Committee has apparently begun some spade work in examining the reg process and whether FDA's independence from HHS might facilitate that process. The committee submitted questions to FDA following the committee's first meeting in May. In a July 9 response to committee chairman Charles Edwards, MD, FDA Acting Commissioner James Benson said that the agency is "conducting a more detailed search of [FDA] records back to 1980" in order to provide the committee "with additional data on regulations development." Benson said that FDA would provide the committee "with a chronology of major regulations issued" since 1980 "showing when each was approved by the Commissioner, signed by the [HHS] Secretary and published in the Federal Register." The data, Benson said, "will give a number of examples of the time required within FDA to draft final regulations following publication of the respective regulatory proposals." However, Benson noted that FDA does not have "detailed information on the amount of time required by FDA staff to develop and draft regulations. This would be extremely hard to measure, because much of the work underlying a regulation may be applied science or review of data that would be done to address the problem whether or not a regulation were to be issued." FDA noted that "about 2% [12] of the 705 FDA Federal Register documents in FY 1989 issued under authority reserved to the Secretary of HHS, who has recently reiterated his commitment to the timely processing of regulations by all HHS offices." These 12 documents include the interim final rule on expediting approval for drugs intended to treat life-threatening and severely-debilitating illnesses. Regarding the possibility of restructuring FDA, Benson said he did not "believe it is FDA's place to suggest whether FDA's interactions with the Department or with Congress should be changed. However, we have suggested some of the issues involved, and some ways which might raise FDA's stature, apart from changing the agency's place within the Administration." In its response to the Edwards Committee, FDA stated that the "notion that enhanced stature will accompany elevated organization placement is convenient logic for proposing higher organizational placement for FDA, but the relevance of this argument depends on how well enhanced stature will actually improve the specific performance of a regulatory agency." Benson pointed out that "the essential whether or not the services provided by oversight layers provide a true 'value added' to the organization served." The acting commissioner added that "while the present arrangement has certain shortcomings, it is not readily obvious that a more independent FDA would be appreciably freer of the considerable time, caution and paperwork imposed on all federal agencies by the multitudinous requirements of government personnel and procurement policies." The panelists were also asked whether they would consider user fees a reasonable source of funding for FDA if there were no other alternative sources. Novitch stated that the only reason industry has been opposed to user fees is "that there is far from being a guarantee, there is almost a certainty that it won't go to the FDA; it'll go to the Treasury. So it won't solve the problem. Hutt, who has "never been in favor of user fees," said that "there is the danger if you have user fees that the Congress will say: 'Yes, we'll give the money to FDA and then we'll reduce the appropriations.'" Committee member James Grant, chairman and CEO of T-Cell Sciences, proposed a different approach for providing funds to FDA that "would in effect enable FDA regulated companies to check off or set aside a portion of the taxes, they would have otherwise paid, to be designated to go directly to FDA." One area of the agency that came up in committee discussions as being severely underfunded is FDA's field laboratories. In his letter to Edwards, Benson noted that "about half of the field's scientific laboratory equipment was past its expected useful life at the end of fiscal 1989, with about $15 mil. needed for replacement and an additional $11 mil. needed for items needed to bring the laboratories up to the state-of-the-art." He added that with "more complex analytical equipment, technological advances can improve the accuracy of tests, expand the range of test functions, and/or improve productivity." Benson noted that "from fiscal 1985 through fiscal 1989, FDA had an average of less than $1 mil. a year for this purpose. Fortunately, in fiscal 1990 we expect to devote about $7.4 mil. to laboratory equipment in the field, in large part because of the additional funding received for the generic drug crisis." He added: "But clearly, more will be needed in the future." The issue of the HHS Inspector General's authority to investigate violations of the FD&C Act arose during a presentation by Principal Deputy Inspector General Bryan Mitchell on the IG's involvement in investigations relating to FDA. Acting Commissioner James Benson told the committee that "the department and the Administration look to the IG as having value in this area, and they're presently working on what that role should be." The IG's authority to investigate FD&C Act felonies was expanded last summer in response to the generic drug scandal; however, in January, HHS Secretary Sullivan redelegated this enforcement authority back to FDA. Rep. Dingell's (D-Mich.) FDA "emergency" bill includes a provision to again expand the IG's investigatory powers as they relate to FDA. The committee noted that it has selected Grant to serve as vice chairman of the overall committee process. On July 12, the panel's three subcommittee chairmen reviewed plans for subcommittee meetings that will take place through the fall. Each subcommittee plans to hold two meetings prior to the next full committee meeting Dec. 17-18. The drugs and biologics subcommittee, chaired by David Kessler, plans its first meeting in Washington on Sept. 27-28 and its second on Nov. 8-9 in La Jolla, California. Kessler noted that the subcommittee is interested in hearing testimony from interested groups on what is expected from FDA's Centers for Drugs and Biologics and whether the center has the necessary tools to carry out its duties. He emphasized that the subcommittee's meeting time is relatively short and that witnesses will be expected to focus their comments. The subcommittee on foods, cosmetics and veterinary medicine, chaired by Sherwin Gardner, will meet on Sept. 6-7 and on Oct. 25. Both meetings will be held in Washington. The subcommittee on devices, radiological products and biomedical research will hold both of its meetings in Washington: on Oct. 15-16 and on Nov. 13. Among the issues the subcommittee will focus on, Chairman Frank Samuel said, is what constitutes competition among manufacturers and how that relates to compliance. Subcommittee meetings are expected to be open to the public. At the close of the session, Edwards reviewed the group's plans for developing an interim report to the HHS Secretary. He said that a draft interim report is expected to be circulated in late August with a final version of the document ready by late September.

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