DRUG SAFETY SECOND-GUESSING AND BIOTECHNOLOGY WILL TOP HEALTH HEARING AGENDAS IN 100TH CONGRESS, ESPECIALLY IN THE SENATE, GOPer QUAYLE TELLS FDLI

Sen. Quayle (R-Ind.) is predicting two years of increased hearings, but not much legislation in the health care area during the 100th Congress. Quayle, who was lined up to succeed Chairman Hatch (R-Utah) as the leader of the Labor & Human Resources Committee if the Republcians had held control of the Senate, told the Food & Drug Law Institute on Dec. 9 that the next "Congress, and particularly . . . the Labor & Human Resources Committee . . . will be much more active in having hearings." The Indiana Republican maintains that under the new Democratic control of the House and Senate the basic "presumption" of the leadership will change in favor of having hearings. Under the Republican leadership in the Senate for the last six years, "the inclination was not to have a hearing -- unless there was a need to." Quayle said: "That presumption is going to change." Quayle forecasts a media-dictated agenda for the 100th Congress. "Anytime that there will be a report -- probably in the media -- about some problem with a drug, (or) a new problem with a process, there will be a hearing." There will be a congressional attempt to "establish a public focus, some public attention on what is perceived to be a problem." Quayle advised the FDLI audience to prepare for more hearings. "Many of you who have been on the Hill and testifying in the past, just be ready, you will be up there more. Just be prepared, because this will be a Congress, and particularly a Senate, that will like to have a lot of hearings." An increased interest in hearings, Quayle said, will reflect a change in the "style of leadership" and the "political philosophy of what the government ought to be." He contrasted the differing approaches of outgoing Chairman Hatch (R-Utah) with Chairman-designate Kennedy (D-Mass.). Despite Kennedy's previous preference for a hearings-dominated agenda, his new committee staffers say there will be close attention to legislation in the 100th Congress -- particularly in efforts to protect biomedical research and the developing biotechnology industry. The biotechnology industry is a growing constituency in Kennedy's home state. Quayle told FDLI that biotechnology will draw "tremendous interest" in the next Congress. He cited questions sych as "What are the problems? Are they perceived problems? Are they real problems? What are they going to do to the consmer?" Among continuing health issues from the 99th Congress, Quayle highlighted Rx drug diversion; amendments to the 1976 medical device act; and FDA resources. Quayle noted the progress made at the end of the session on a compromise to the diversion bill proposed by Rep. Dingell (D-Mich.). The bill "made progress in the House; I think it will be back on the table in the Senate," Quayle said, indicating that legislation on the diversion topic is almost a certainty. The Indiana Republican does not believe that FDA's relationship with Congress will be carried over as a topic into the 100th Congress. Sen. Gore (D-Tenn.) and Rep. Waxman (D-Calif.) have been pushing for congressional approval for the appointment of the FDA commissioner to tighten the Hill's control over FDA. Quayle, however, believes the issue is not ripe. "There may be some hearings; there may be some discssions," the Republican said, "but for the next two years, I do not see that." FDA's budget needs will face a tough battle in Congress, Quayle said. When a government program has a discretionary account, Quayle observed, and Congress does not have to change a law to lower the budget, "it is an easy target, and it is very difficult to increase." Quayle said he was "impressed" by the representatives of regulated industry who lobbied for dedicated FDA user fees in 1986. "Normally," Quayle said, the regulated industry says "we're not too sure" about supporting increased resources for FDA. "Last year, in particular, there was an admission" that FDA needs added resources. Increased FDA funding, Quayle said, "will be a very difficult proposition unless you are willing to concede the fact that you are going to have some kind of dedicated fund to be used for it." Quayle said FDA user fees channeled into general Treasury revenues would be rejected by the Hill again. The movement to amend the Delaney clause is over, Quayle told the audience of lawyers. For the last four years, Quayle observed, there has been discussion of how to modify the carcinogen clause. He pointed out that efforts to amend the clause have run up against the political reality that no congressman wants to look like they are in favor of cancer. "Most senators and congressmen," Quayle said, are afraid that being on the side of any modification of the Delaney Clause makes them vulnerable to charges that they are "for creating more cancer." Quayle said that the Hill is more comfortable leaving the Delaney Clause up to the interpretation of FDA. He pointed out that also permits Congress to step in in situations like saccharin and appear like the defender of the public opinion and preference. "It makes a nice political situation," he said. He also noted that the penchant for legislating specific labeling will continue: "If Congress can't pass a specific statute dealing with some major change, pass a labeling bill." Legislators reason that "at least we can get out the disclosure, we can get the information out to the consumer," Quayle said. "Some of the labeling I think has merit. Others I don't think have merit. I think when you look at this thing, and information -- certainly we want it to be made available. But I find much of the labeling legislation is basically an exercise in frustration. They don't have the political support to do some of the things that they would like to do; instead they go ahead and label it."