Tobacco Documents Online

~ ~...,..~ gC,t~gS A-U, An FDA Smoke Screen By Roemrr Gouffec David Kessler is Washington's latest Comeback Kid. Less than a month ago. the Food and Drug Administration was backpedaling, pledBing to reinvent itself- to farm out activities that private agencies could do faster and more effectively, and to eliminate regulations that add nothing to the public health. Today, the FDA is back in business wtth more swagger and certainty of mission than ever because of its crusade against tobacco, particuiaFly as it relates to children's healtti. But protecting the health of children may not be the only consideration in the FDA's new campaign to regulate tobacco. Surely the FDA and its allies in Congress and the White House realize how effec- tively an imminent threat to the public can renew the leverage of an agency many Re- publicans are trying to eliminate. About 35 years ago, another "imminent crisis" helped the FDA solidity its power within Washington's politicized regulatory net- work. The now legendary 1962 FDA intercep- tion of thalidomide before it reached the U.S. market allowed the agency to assert increasingly broad control over every as- pect of medical progress. As is weU known. thalidomide was a sleeping pill that caused birth defects when taken by several thou- sand pregnant women in Europe. We now take for granted that but for the diligence of the FDA. American babies would have suffered the same horrible fate. In fact, ac- cording to an account written by econo- mist Joseph D. Cooper (which appeared as an essay in the book "Regulating New Drugs." University of Chicago Press, 1972): "thalidomide had been blocked for non-relevant reasons Isimply because of bureaucratic slothl. and was actually mov- ing toward approval when the drug com- pany itself reported the terrible news." It took the FDA more than four months to realize that many, many people were still at risk. But even that comprehension was provided from the outside by Dr. He- len Taussig of Johns Hopkins University. More months. passed before the FDA moved with dispatch, this time with the aid and insistence of President Kennedy. Months after the en- tire matter had been reported. Sen. Estes Kefauver and his staff, along with the FDA, contrived to dramatize the cata- strophe through the medium of the press as a means of secur- ing passage of legisla- tion eivin¢ the FDA Damd Kessler pharmaceutical in- dustry. The tactic worked. The world was at last shocked into action, the legislation passed, new heroes were manufactured. Ironically, the powers Congress gave the agency in 1962 had nothing to do with drug safety. Instead, the Kefauver amend- ments totoe FDA's charter allowed the agency to hold up drugs it thought could not do what companies claimed. And since that time, the FDA has undermined the public health with capricious decisions and arbitrary delays without any offsetting safety benefits. For 30 years, by invoking its legendary defense of public safety in the thalidomide case. the FDA has sat on or rejected drugs for depression, schizo- phrenia, kidney cancer and epilepsy- not because they were unsafe, but because in the final analysis the agency didn't think the drug was so important or effective. Tobacco is today's thalidomide, allow- ing the FDA to "reinvent" itself as the only thing standing between our children and certain danger. In fact, there was no need to expand the FDA's authority to protect pregnant women from taking thalidomide: alert consumerism and a community of re- searchers made the public aware of that danger. SimilaHy, the percentage of smok- ers has declined dramatically since 1971. Even if tobacco companies are spiking cig- arettes to keep people hooked, public in- formation on smoking's link to cancer and Its declining acceptability has changed public behavior. As with thalidomide, the FDA is riding to the rescue well after Americans found other means to protect their health. The tobacco issue has allowed the FDA to rise, thalidomide-like, from the ashes and regain its regulatory roost. Legisla- tive efforts to reform the agency are likely to stall. The FDA's reputation is enhanced enough that President Clinton thinks his re-election chances will be helped by iden- tifying himself with the agency's initiative to regulate a whole new industry. No doubt we would save more lives by reducing the FDA's control over medical progress than we will by getting the agency into the reg- ulation of cigarettes. When the FDA has to choose between sustaining its political power or protecting the public health. it will invariably invoke the latter to protect the fotmer. not the other way around. .tifr. Goldberg is a senior research telfou• at Brandeis Gnit'erstty's Gordon Public Pol- icy Center.