Government
Kennedy defends FDA policies and actions FDA commissioner Donald Kennedy speaks openly about his agency's reputation, its duties, and how it doesn't always get a fair shake On Aug. 30 an article by science writer Daniel S. Greenberg appeared in the editorial section of the Washington Post. In the article Greenberg implied that not much has changed at the Food & Drug Administration lately and that its new leader, 46-year-old Stanford University neurophysiologist Donald Kennedy, has been slow to bring about change at the sometimes troubled federal agency. Because of these and other reasons, Greenberg suggested, Kennedy's "honeymoon" with the press and with public opinion probably was over. By coincidence, the same day the Post article appeared, FDA commissioner Kennedy was interviewed by C&EN's Christopher Murray. Although reluctant to respond to many of the points Greenberg raised, Kennedy did address indirectly one case in particular, that of FDA scientist Dr. John Nestor who claims that he was transferred to bureaucratic Siberia because he was perceived as adversarial towards the pharmaceutical industry. In 1975 Nestor, along with several other FDA staffers, charged that the agency was dominated by the pharmaceutical industry. These latter charges were largely refuted, however, in a two-and-one-half year study of the agency by an independent panel chaired by lawyer Norman Dorsen of New York University and set up by FDA's parent, the Department of Health, Education & Welfare. The new FDA head was not pleased. "I really don't need Dan Greenberg to tell me my honeymoon is over," Kennedy says. "I don't think it ever started.... He's saying that the press and the consumer groups have been kind to me so far and I guess he's implying that if I don't give Dr. Nestor his old job back that they are going to start being unkind to me. I'm not going to be pushed around by that kind of thing." However, the FDA commissioner was willing to speak more freely about the scientific and public policy issues facing the agency, in particular the often repeated observation that FDA is constantly under siege from many sides. "I think that that's an artifact of the kind of
press attention that FDA receives. Everybody tells me, for example, ' y ° u must have spent all your time on Laetrile and saccharin.' Well, the fact of the matter is I haven't spent anything like all my time on Laetrile and saccharin. I've spent a lot of time reviewing regulations. I've spent a lot of time on analyzing and trying to improve our review of over-the-counter drugs. I've spent a lot of time visiting our field offices and worrying about our compliance programs," he insists. "90% of what this agency does in the public interest is outside these very special battles that center around the new drug approval process or the removal of a few food additives. It's those issues that give the agency the impression of being under siege. You're only under siege when you spend all your time explaining yourself to Congress." Yet Kennedy did spent a lot of time on Capitol Hill shortly after he took the helm at FDA, mostly to explain why FDA wanted to ban the artificial sweetener saccharin, which in high doses has been found to produce bladder tumors in rats. "The saccharin business," he observes, "is a little bit of Congress' own agony as the Congress know perfectly well." FDA, Kennedy insists, "did exactly what the Congress had told it to in the saccharin case and [based] on perfectly good science. If there is a defect, it's a defect that has to be repaired on Capitol Hill, not at the Food & Drug Administration." In repairing the defect, though, Kennedy believes Congress "ought to address it generally as it applies to the universe of food additives. [Congress] ought not merely remove the discomfort of the saccharin furor by declaring a moratorium and then go about its business.... I do not believe that Congress wants to put itself back into the business of making regulatory determinations on a compound by compound basis—that, as I am learning, is not the best job in the world if you also have other responsibilities." Moreover, he observes that "Congress is vulnerable to local or special interest pressures because of the sectional character of its representation in a way that a federal regulatory agency is not. As a consequence, it was the wisdom of Congress years ago to put such matters in the hands of folks who don't have to get elected." When FDA decided in March to ban saccharin, the agency invoked the socalled Delaney clause of the Food, Drug & Cosmetic Act, named after New York Democrat Rep. James J. Delaney who wrote it into the act in 1958. This clause says that no food additive that produces cancer in experimental animals will be
permitted in food for human consumption. Because of a storm of protest (somewhat engineered by the food industry) over the saccharin ban proposal, Congress is moving with unaccustomed speed to block FDA's plan. Other bills have been introduced this session to modify the Delaney clause, including one by Rep. James G. Martin (R.-N.C), an organic chemist, which would allow risk benefit decisions concerning food additives of questionable safety. Kennedy concedes that FDA hasn't yet decided what position it will take on the Delaney clause, but he does believe that "the De-
"The saccharin business is a iittle bit of Congress' own agony" laney amendment has been basically a good consumer protection law. If it needs anything it needs mainly fine tuning . . . . It does not need scraping or radical revision." Although he doesn't say just what this fine tuning should be, Kennedy admits that the Delaney clause "needs to contend with analytical sensitivity in a way that it didn't have to in the year of its birth." Just as the agency has been accused of acting precipitously in the saccharin case, FDA has been denounced (often by industry, generally privately) for moving at a snail's pace in approving new drugs for human use. FDA also has been indicted for arbitrarily preventing the use of valuable drugs in the U.S. while these same drugs are being used successfully overseas. In July Kennedy conceded to a Senate Health subcommittee, "Consumers are poorly served when they are denied access to products that may help them by relieving pain or suffering, or by curing a disease or ailment." But he denies that the agency acts with deliberate lack of speed on new drug apSept. 12, 1977 C&EN
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pro vais. "We've shown pretty good foot in a number of cases of therapeutic innova tion in the past. There's no question that when we see a drug is potentially capable of yielding a unique therapeutic benefit we're capable of putting it on a fast track. The fast track involves both allocating greater than the usual amount of re sources to expedite the process—not short cutting in any way—but just making sure that it's on top of every pile that it sees. I hope that the formalization of that pro cedure is going to be possible for us. I think that a regulatory agency ought to lay out incentives for breakthrough in novation. The incentives should not be for anything that is new at a level [of] sort of patentably different. We ought to be providing serious incentives for substan tial breakthroughs." Kennedy says that cimetidine, an antiulcer drug developed by Smith Kline & French Laboratories and quickly approved by FDA, is a good example of what can be done. On the other hand, Kennedy asserts, "The bummest rap going on FDA is the sodium valproate rap. We're being ac cused of holding up approval of a valuable anticonvulsant drug when in fact the drug has just not attracted enough interest on the part of Abbott Laboratories, which is licensed to make it in the U.S." To speed things up a bit, Kennedy has proposed that FDA be given authority to permit distribution of new drugs under controlled clinical situations, but not with complete approval for widespread use. "We think that limited distribution au thority ought to be available for more than just investigational purposes . . . not just as part of its investigational history, but as a matter of its general use." He cites drugs such as methadone, anticancer drugs, and medical gases as examples of drugs distributed only in limited medical channels that could be allowed out before all the data were in. What Kennedy proposes is similar to the so-called phase IV clinical trial con cept laid out in drug law revisions (S. 1831) written by Sen. Edward M. Ken nedy (D.-Mass.). "We think that [Sen.] Kennedy's Phase IV carries a little too
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much freight. Patient package insert au thority, adverse drug reporting systems— all that stuff is tacked onto phase IV which is limited distribution for the pur pose of demonstrating safety and effica cy." Commissioner Kennedy prefers to call his idea "an NDA [new drug approval] with restrictions." When FDA isn't policing the pharma ceutical industry, it looks after a number of other responsibilities. The latest of these is its investigation into the practices of independent testing laboratories that conduct safety studies of drugs, pesti cides, and food additives for manufac turers seeking government permission to sell their products. Recently the Envi ronmental Protection Agency disclosed that it has in its files faulty data used to support pesticide registrations. To make things worse, much of the shaky data were produced by the same independent lab oratory—Industrial Bio-Test Laborato ries. "[FDA] discovered the problems at
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Industrial Bio-Test—they're horrifying," Kennedy asserts. Will the good laboratory practices that FDA has proposed help clean things up in the toxicology testing business? "Only with strict compliance efforts," Kennedy answers, and even then "if somebody is going to be fraudulent, good laboratory practices are just some thing else for them to ignore. [But] I think that they may go some distance towards cleaning up shoddy science." "But I'll tell you," he continues, "I'm worried about the condition of our toxic chemicals testing establishment out there. Even if it were perfect it is not big enough to do the job under the new authorities in TSCA [Toxic Substances Control Act] and FDA's review obligations." All in all Kennedy concludes, "I think my predecessors did a pretty good job in running this agency. I think the old fa miliar wheeze that FDA is somehow too closely involved with industry has been successfully laid to rest by the Dorsen panel. I hope nobody believes that any more. It was never true, and it certainly isn't true n o w . . . . I don't think I'm going to be necessarily tougher than FDA was in previous administrations. I expect to annoy both industry and consumer ac tivists from time to time." •
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