Faster FDA approval of new drugs urged The Pharmaceutical Manufacturers Association, hoping to keep prodding the Food & Drug Administration toward faster approval of new drugs, is sending a clear message to the new Bush Administration: Keep Frank E. Young as FDA Commissioner and increase funding for FDA without taxing the drug industry through user fees. It took FDA a lamentable average of 31 months to review each of the 20 new drugs it approved for market in 1988, according to PMA president Gerald J. Mossinghoff. In contrast, the regulatory review period in other countries where 16 of those drugs had previously been approved averaged only one year. Nevertheless, Mossinghoff hopes that changes Commissioner Young has initiated will work to speed the process in the U.S. "PMA strongly supports Young in his and his colleagues' efforts to make the approval system more efficient," Mossinghoff says. "Changing things in the federal bureaucracy is like turning a large ship around in the Potomac. The key
thing is continuity. We are still optimistic he can turn things around." Young's future in the Bush Administration was still uncertain as of press time. He had not been asked to resign, but neither had he been reappointed. Mossinghoff rejects as a "tax on innovation" a user fee proposal for FDA included in President Reagan's budget that was submitted to Congress in early January (C&EN, Jan. 16, page 6). Under that proposal, $100 million out of the $220 million allocated to FDA for drug programs would be collected from manufacturers seeking to have their products reviewed. PMA, the Industrial Biotechnology Association, and two other associations representing drugs, medical devices, and biotechnology have formed a coalition to lobby against the proposal. "The only way we could accept these user fees is if there was some kind of plan where there would be assurances that concrete improvements at FDA would be made based on the fees," Mossinghoff says. Pamela Zurer
AAAS SAN FRANCISCO
Kennedy cites activist, singleissue, not-in-my-background politics that block or delay construction of research facilities. And as evidence of "a new and corrosive popular mistrust of scientists and their work," he cites the media popularity of the issue of scientific fraud. Kennedy calls for "a lot more stiffness by scientists in the face of the special political interests that are hostile to American science." If organized science entered the battle against all these forces with the same invigorated self-interest scientists annually bring to the appropriation cycle of the National Institutes of Health and the National Science Foundation, he says, "We would all be better off." Scientists should also downplay the utilitarian promise of their own work, Kennedy adds. With international competitiveness becoming the research policy buzzword of the decade, scientists have tended to justify, and sometimes oversell, science on utilitarian grounds.
Science mistrusted by public, keynoter says "Science in contemporary America finds itself in the midst of a paradox," says Donald Kennedy, president of Stanford University. "The American public believes in progress, believes in science, and admires [us] as practitioners. But it displays an alarming level of mistrust about our motives." In a keynote address to the annual meeting of the American Association for the Advancement of Science in San Francisco last week, Kennedy cited as one by-product of that mistrust the crumbling infrastructure for basic research. A second consequence is the difficulty universities face in efforts to recover indirect costs of sponsored research or to develop other funding sources for infrastructure maintenance and improvement.
Kennedy: science in midst of paradox "Therein," he says, "lie several traps for the unwary. First, it is not nice to disappoint people, and it is downright dangerous to disappoint your Congressman." Second, the utilitarian argument encourages a "pernicious" notion that if research money is appropriated geographically, economic prosperity will distribute itself along with it. And third, when research is placed on a utilitarian footing, patrons are unwittingly encouraged to adopt a procurement model that most basic scientists would not be comfortable with. James Krieger
AAAS SAN FRANCISCO
Chemistry presence strong at conference Chemists often have been reluctant to present their work at annual AAAS meetings. Too few of their chemical peers attend what is essentially a meeting for generalists. But this was not the case at this year's AAAS meeting, where, for the first time in a long time, chemical luminaries reviewed developments in their fields for peers from other disciplines. Attendance was better than middling, and the speakers were pleased enough to say January 23, 1989 C&EN
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