FDA Clones Misguided Regulatory Policy

The Food and Drug Administration (FDA) has just launched two salvos in federal agencies' war against biotechnology by attacking various manifestations of the biological process called cloning, in which a mature cell--from the skin, for example--from the animal (or human) to be copied is inserted into an egg whose nucleus has been removed. The resulting embryo is then implanted into a surrogate mother that carries the fetus to term. In response to public claims by two groups that they are attempting to produce a human baby using the cloning technology used to create Dolly the sheep and other animals, a senior FDA official in March threatened to shut down any such attempts. Dr. Kathryn Zoon, director of the Center for Biologics Evaluation and Research, testified that "FDA views the use of cloning technology to clone a human being as a cause for public health concern," and assured members of a subcommittee of the House Committee on Energy and Commerce that "FDA would not permit any such investigation to proceed." More recently, the agency told companies that clone livestock that neither the duplicated animals nor their offspring may enter the food chain. Officials at the FDA's Center for Veterinary Medicine have said they consider these genetically identical cattle and pigs--analogous to Dolly, the first cloned mammal--to be "experimental," and therefore not appropriate for human consumption. Human cloning offers thorny ethical issues, to be sure. The failure of the procedure could mean either the premature "death" of the clone, or its survival with grotesque malformations. Moreover, there is no clear medical necessity for the procedure, no patients whose life or limb is at risk without it. What does seem clear is that FDA lacks the mandate to interdict such research. The agency is responsible for regulating products--drugs, vaccines, pacemakers, X-ray machines, foods and other items that meet certain statutory definitions--but not processes or concepts like "human cloning." For example, the agency evaluates and must approve the drugs used by fertility clinics but does not license or inspect the clinics themselves. The scientific and medical communities are quite skeptical that even the most expert fertility specialists can perform human cloning successfully with current technology, but in a sense that's beside the point. Cloning does not involve the testing, use or sale of an FDA-regulated product, yet we have Dr. Zoon pushing the regulatory envelope and asserting jurisdiction. FDA's meddling in the use of animal clones is also unwarranted. Cloned livestock have heretofore received little regulatory attention, even as the technology has evolved since Dolly was born in 1997. Farmers have already begun ordering animals that are identical genetic copies of an existing animal, but the FDA says it doesn't believe that meat or milk products have yet reached the marketplace. At least with respect to the cloning of animals, it does not seem clear to the regulators themselves or to anyone else exactly whom FDA is trying to protect, or from what. Although there is an increased mortality rate compared to naturally conceived offspring, the animals that arise from cloning and survive appear completely normal in every way. What does seem clear is that, as in the case of human cloning, FDA lacks the mandate to interdict such products. The agency is responsible for regulating veterinary drugs--a category that meets certain statutory definitions--but, as noted above, not processes or concepts like "cloning," which is very similar to proven technology such as in vitro fertilization (which is not regulated by FDA). Nor has FDA interfered during decades of commerce in and consumption of various novel genetic hybrids, such as the beefalo, a hybrid of cow and buffalo. As one technologically bullish farmer who owns a pair of clones of a prize-winning Holstein cow observed, they're simply twins of "a cow that was already in production." FDA jurisdiction over cloning, and the need for premarket approval of the process, would be ominous. The FDA officials involved are the same regulatory geniuses who took nine years to review and approve bovine growth hormone, the excellent and widely used gene-spliced veterinary drug--compared to the 18 months that other regulators at the agency had needed previously for approval of the human analog, human growth hormone. (Uncertainty about the timing and expense of regulatory approval are anathema both to corporate planners and to end users who are considering the adoption of a new technology.) Why is FDA continually pushing the envelope, creating still more regulatory disincentives to using biotechnology? First, regulators are always seeking to expand their mandates and responsibilities. Bureaucratic power and perks are increased by larger empires and budgets. And besides, it's in their nature--then-FDA Commissioner Frank E. Young once quipped that, "Dogs bark, cows moo, and regulators regulate." Second, regulators are part of a lopsided decision-making process that is inherently biased against change and therefore against innovation. To see why, one must understand that there are two basic kinds of mistaken decisions that a regulator can make: First, a harmful product can be approved for marketing--called a Type I error in the parlance of risk analysis. Second, a useful product that treats or prevents disease can be rejected or delayed, fail to achieve marketing approval at all, or be inappropriately withdrawn from the market--a Type II error. In other words, a regulator commits a Type I error by permitting something harmful to happen and a Type II error by preventing something beneficial from becoming available. Both situations have negative consequences for the public, but the outcomes for the regulator are very different. A classic illustration is the FDA's approval in 1976 of the swine flu vaccine--generally perceived as a Type I error because although the vaccine was effective at preventing influenza, it had a major side effect that was unknown at the time of approval: A small number of patients suffered temporary paralysis from Guillain Barré Syndrome. This kind of mistake is highly visible and has immediate consequences: The media pounces, the public denounces, and Congress pronounces. Both the developers of the product and the regulators who allowed it to be marketed are excoriated and punished in such modern-day pillories as congressional hearings, television newsmagazines, and newspaper editorials. Because a regulatory official's career might be damaged irreparably by his good-faith but mistaken approval of a high-profile product, decisions are often made defensively--in other words, to avoid Type I errors at any cost. As an FDA official for many years, I call this approach the sweaty palms school of policy-making: When you're vaguely uneasy, or you're not smart enough to understand a new product or technology, interdict or delay. Third, there are only a couple of companies that perform animal cloning commercially, so the biotechnology trade associations haven't shown any interest in protecting their interests. Only a few civil libertarians and students of regulation are likely to remonstrate. FDA has a long and unsavory history of pushing the regulatory envelope beyond what is legal or in the public interest. The agency's attempts to regulate cigarettes as a "drug delivery device" were rejected by the courts after lengthy and expensive litigation. Similarly, FDA's attempts to interfere with constitutionally-protected commercial free speech--in the form of drug companies' distribution of articles and textbooks describing not-yet-approved uses of marketed drugs--have been repeatedly struck down and condemned by the judiciary. The FDA's requirement that companies perform drug testing in children represents a shocking attempt to arrogate the prerogatives of the private sector. And the agency's historic decision to remove harmless breast implants from the market unnecessarily terrified thousands of women, fostered spurious litigation for non-existent damages, drove Dow-Corning into bankruptcy and interrupted the availability of silicone for other essential pharmaceuticals. A fundamental question about this not very brave new world of regulation is the appropriate threshold for the use of federal executive power. During the Clinton administration, whatever the issue, government action seemed invariably to be the remedy of first resort. Any societal ill, inequity, or iniquity was fair game for federal relief. The current controversy is more about the abuse of federal power than it is about the abuse of cloning technology or the possible risks of a cloneburger. It will be instructive to see to what extent that power is reined in when the Bush administration appoints a new head of the FDA. Let's just hope the nominee isn't a clone of the last two. Henry I. Miller, M.D., is a fellow at Stanford University's Hoover Institution and the author of "To America's Health: A Proposal to Reform the FDA." He was an FDA official from 1979 to 1993 and head of its Office of Biotechnology from 1989 to 1993.

FDA Clones Misguided Regulatory Policy

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