PERSPECTIVE ON THE FDA : When Politics Drives Science : Under Clinton, interest groups win out over advancements in research on food and drug products.
When David Kessler became the Commissioner of the Food and Drug Administration in 1991, he found the agency to be ponderous and slow. Kessler promised dramatic changes, that he “would teach the elephant to dance.” And he has--to a tune called by politicians.
During my 15 years’ involvement with and observation of the FDA, which has spanned the administrations of four presidents, the agency has encountered different management styles and regulatory philosophies. But never was raw political influence permitted to dictate decisions on policy and products as in the Clinton Administration. The regulatory process is no longer impartial and dependent on law and science, but operates as if the issue were which interest group deserves a reward.
Last year, for example, when a new female condom was under review, the agency was reluctant to approve the product in view of its controversial 26% failure rate in normal use. Other contraceptives were much more effective: Male condoms had a failure rate less than half and hormonal methods less than one-tenth that of the new product. But the word came down from the politicos in the Health and Human Services Department that they wanted the product approved. Damn science and medicine, it had the support of feminists. Approval soon followed.
Biotechnology policymaking and product review provide perhaps the most illuminating example of the rise of political influence at the agency. The FDA had a consistent and generally positive 15-year track record of regulating biotech. Since 1979, there had been a conscious decision that scientific considerations would dictate regulation. Furthermore, the fairness, predictability and impartiality of the regulatory review process stimulated researchers, companies and investors to favor this industrial sector. As a result, more than 1,000 new biotech products have been approved for marketing, including some genuine medical milestones for diseases ranging from cancer to cystic fibrosis and multiple sclerosis. Millions of patients have been treated with these safe and effective products, and hundreds more new products are in development.
During the past 18 months, however, the FDA has shown an unmistakable change on biotech policy. New instructions from the Clinton Administration have undermined the scientific paradigm that has been the basis for policymaking over the past 15 years: that new biotech techniques are extensions or refinements of earlier techniques and that the degree of regulatory scrutiny will be determined by risk. Signaling the reversal, the FDA has announced that it will soon require food manufacturers to notify the FDA before marketing foods manufactured with new biotech techniques--high-precision recombinant DNA or gene-splicing techniques--while exempting those crafted with other, cruder techniques such as hybridization or mutagenesis.
With these moves, the agency appears to be seeking new regulatory dominions in spite of its cries of inadequate resources. Most certainly, the new policies will discourage the use of the newer, more precise techniques, denying consumers the choice of more nutritious, tasty and convenient products. These changes are reflections of a very different attitude about the relative roles of science and politics in policymaking.
During the recently completed review of the milk-stimulating drug, bovine somatotropin, Kessler directed a vigorous search for reasons not to approve it. Now that BST has been approved (reluctantly), the FDA is permitting stores that sell dairy products to flout the agency’s policy on labeling--which has the effect of “damaging” BST’s acceptability. Many food markets have signs over the dairy case proclaiming “NO BST.” However, cows’ milk normally contains BST, a naturally occurring protein; thus the label is inaccurate. The milk-containing products in the case could, therefore, be considered misbranded, a violation of federal law. Neither FDA nor any state agency has taken action.
Other changes also reflect the new order. Since the 1992 elections, Kessler has eliminated the two policy offices having extensive involvement with the biotechnology industry, with veteran scientists (including me) swept aside. Direction on science policy (and sometimes even on civil-service personnel matters) is now provided by a political commissar, Jerold Mande, a former Senate staffer of Vice President Al Gore.
At the FDA, which overseas food and health-care products accounting for 25 cents of every consumer dollar--more than a trillion dollars worth annually-- consumer protection and competition in the marketplace are increasingly at the mercy of politics and politicians. Is this any way to run a regulatory agency whose job is to ensure that products are safe and that quacks cannot prey on the public?
