FDA LEGISLATION FROM 101st CONGRESS IS MOST SINCE 1938: AGENCY FACES AS MANY AS 13 NEW LAWS TO IMPLEMENT, FROM MEDICAL DEVICES TO GARBAGE BACKHAULING

The 101st Congress left FDA the largest legislative legacy in over half a century: the agency is currently tracking the progress of five bills passed at the end of the congressional session and awaiting final okay from the White House. Overall, 14 FDA-related bills passed the 101st Congress in its final weeks: eight were signed by the President by Nov. 23. A ninth, the FDA Revitalization Act, is apparently headed for a signature. Sen. Hatch's (R-Utah) Director of Health Policy Nancy Taylor told a seminar on the status of FDA on Nov. 13 that the revitalization bill has "gotten the green light from the White House." Presidential action on the five pending bills is expected shortly -- each must be signed by Dec. 1 in order to become law. There has been one veto: the President did not sign the amendments to the Orphan Drug Act by the Nov. 10 deadline ("The Pink Sheet" Nov. 12, T&G-1). The 1990 legislation is the most bountiful harvest for FDA since the 75th Congress during the New Deal. FDA Deputy Commissioner James Benson describes the work of the 101st Congress as "the largest load of legislation the agency has had to deal with since 1938 when the major FD&C Act was passed." Speaking at the Nov. 13 seminar sponsored by the National Health Council, Benson indicated that, in addition to the safe medical devices, FDA revitalization and food labeling acts, the agency would be affected by "a long laundry list of additional legislation," ranging from garbage backhauling to the farm bill. Benson suggested that the new laws may pose an even greater burden on FDA than the 1938 act, "because Congress has gotten a lot more prescriptive in their legislation, so, in a way, you have to be more careful. It's even more work for the agency in determining what Congress really meant." Rep. Waxman's (D-Calif.) health subcommittee counsel, William Schultz, explained that the current legislation "is so prescriptive" because of the "perception in Congress -- and I think that perception is a reflection of the perception in the public -- that FDA just hasn't been doing its job" regulating and enforcing legislation in specific areas. The heavy load of new legislation offers FDA a timely challenge, Benson said. "Frankly, we haven't done that very well in the past, at least in my history," Benson said, "So we have an obligation to both the department and to the Hill -- and to the public -- to say: 'Here's what we've been asked to do, here's the cost, and here's the time it will take.'" He also acknowledged that "we should do better at getting regulations out. I don't want to waffle on that." Schultz, Taylor and a top aide to Rep. Dingell predicted to the National Health Council that user fees and FDA autonomy would continue to dominate congressional interest in the agency during the next term. Schultz, in particular, emphasized the issue of FDA autonomy. "I think that the task of effective enforcement and effective regulation is made a lot harder by the agency's lack of independence," the Waxman committee staffer said. "You now have a situation," he continued, "where regulations, in addition to going through all the levels of review at FDA...must go through the Assistant Secretary of Health, the Secretary of Health, and then [the Office of Management & Budget]. The result is both delay in most cases, and in some cases a change in the policy that I think can be demoralizing for the agency and that I think in many cases can result in bad public policy." [EDITORS' NOTE: See T&G-8 on Capitol Hill's view of the OMB/FDA relationship.] Independence within HHS could also enhance FDA's ability to increase its budget, Schultz contended. The various superior agencies who look at FDA's budget request "are not looking at ways to increase the agency's budget...they are looking for ways to reduce the budget." Hatch aide Taylor agreed that FDA independence would be an issue next term. She sided, however, with the majority of ex-FDA top officials, saying that it might be best to keep the agency within HHS and the Public Health Service. Even an independent agency, she said, "still must function within politics" and "must fight for every penny that they get as an agency and for every authority that they get." She added: "It would be sad to see a $600 mil. agency have to fight against the behemoth HHS at the budget roundtable. I think it would be a sad day for FDA." As for removing FDA from PHS, she suggested that "by taking [the agency] out of the Public Health Service, you would be strengthening their mission as a regulator, but you would be taking them out of their research mode." Charles Edwards, MD, ex-FDA commissioner and current chairman of the top-level HHS review committee looking at the agency, said that "in my opinion at least, the key issue here may not be where FDA is located in the bureaucracy, but rather what degree of authority the agency needs to do its job...The real question is not whether to make FDA more independent, but how to make it more effective." Former FDA Deputy Commissioner Mark Novitch, MD, (now with Upjohn) said that all FDA needs is "more independence within HHS...It doesn't need all the handholding it gets from the department, from OMB, and indeed from the Congress." Taylor identified several other areas of congressional action relating to FDA that will come next term. "There will be legislation dealing with greater enforcement powers...Sen. Hatch has made a commitment to Rep. Dingell [D-Mich.] to look at enforcement in a broad sense as well as in a narrow sense with the generic drug problem. In addition there will be another examination of the orphan drug program," the Hatch staffer said. Taylor also reiterated the position taken early in 1990 that "user fees are coming" ("The Pink Sheet" March 19, T&G-6). Lesley Russell, PhD, a staffer for Rep. Dingell's Energy & Commerce Committee agreed that user fees will come up next term. "It is very possible, almost completely likely that [the debate over user fees] will in the next Congress be conducted in the context of looking at some legislation," she said. Russell indicated that "my favorite proposal is an annual registration fee," an idea espoused recently by Sen. Kennedy (D-Mass.). Russell suggested that such a fee would help to "spread the pain fairly evenly" while at the same time helping "FDA keep track of the universe that it is supposed to be regulating." She also indicated that "there are some precedents here. Many pharmaceutical companies pay such registration fees when they do business overseas." Pharmaceutical Manufacturers Association Exec VP Robert Allnutt noted that there is "a great deal of agreement between industry and those on the Hill who want to do something to improve the situation at FDA, which greatly needs improvement." He contended that the debate has not advanced far because of the simplistic approach to user fees proposed by the Reagan and Bush Administrations over the past five years. "Partly because of a series of pretty mindless administration proposals," Allnutt said, "we have failed to really have a good discussion over what really could be done, what might be realistic. Perhaps that time has come." Chart omitted.