FDA Authority to Restrict Cloning Debatable

Reacting to reports that several groups were poised to attempt human cloning, the FDA in March issued letters warning researchers that the practice is subject to agency oversight, but legal experts say the FDA's assertions may not hold up in court, the Washington Post reports. Although the FDA has no authority over "how doctors practice medicine," the agency claims its authority over human cloning is granted through the Public Health Service Act, which gave the agency the right to regulate "biological products," defined as "any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component ... or analogous product" used in treating medical conditions. The agency says that cloned embryos are biological products designated to treat infertility. But University of Florida law professor Lars Noah said the agency is making a "remarkable claim," adding that its definition "goes well beyond any reasonable interpretation of the law," and Elizabeth Foley, a professor of law at Michigan State University's Detroit College of Law, called the FDA's position "undefendable." The FDA also claims authority over cloning under the Food, Drug and Cosmetic Act, saying that cloned embryos are "drugs" meant to "affect the structure or any function of the body" through pregnancy. Kathryn Zoon, the director of the FDA Center for Biologics Evaluation and Research who sent the letters, said the agency is "very confident that our jurisdiction is appropriate."

Support for the FDA's position has "[c]uriously" come from those who would be subject to agency regulation, the Post reports. Carl Feldbaum, president of the Biotechnology Industry Organization, said that his group has "looked into this very seriously and ... determined that the FDA does have clear and far-reaching authority to regulate efforts to clone human beings." Some observers say researchers would prefer that the FDA have authority because if forced to choose between FDA or congressional oversight, the FDA "is seen as the lesser of the two evils," according to the Post. The FDA is only "legally bound" to weigh "objective concerns," such as safety and efficacy, not moral issues, such as when life begins. If human cloning was proven to be safe, the FDA would be "obliged" to permit the research, the Post reports. The agency is also directed to "protect the consumer of cloned embryos" and not the embryos themselves, which are considered commodities. According to the Post, the agency has "no regulatory qualms" about permitting researchers to create embryos for stem cell research, which requires "destroy[ing]" them to access the cells, something some see as "tantamount to murder."

The debate over the creation and destruction of embryos for research purposes and medical procedures has put "pressure" on Congress to step in and pass a ban on human cloning. The six different bills currently before Congress range from outright bans on human cloning to those that allow exceptions for cloning of human embryos for research purposes. Legal experts cannot agree on whether any sort of ban on the procedure would "pass muster with the Constitution," and many say that Supreme Court references to procreation as a "fundamental right" of citizens indicate that in order for any law to be upheld it must be "tailored as narrowly as possible to address specific and objective concerns."

Alta Charo, a University of Wisconsin law professor, said that if the Court was "interested in protecting a broad notion of genetic connection to the next generation," then cloning might be included as a fundamental right. However, Clark Forsythe, a lawyer and president of Americans United for Life, said that there is "nothing in Supreme Court case law to suggest that noncoital, asexual reproduction is a fundamental right." The court has "hinted" that in vitro fertilization stands as a fundamental right, but some argue that cloning cannot be placed in the same category because it is not so much procreation as it is "replication." Legal experts also say that a ban on the procedure could be interpreted as a violation of scientists' First Amendment right to "pursue their intellectual interests" (Weiss, Washington Post, 5/23).