The Goldwater Institute submitted a friend-of-the-court brief to the U.S. Supreme Court today in a lawsuit challenging the Food and Drug Administration’s authority to restrict access to individualized medical treatments involving stem cells. Months ago, the Ninth Circuit Court of Appeals declared that these treatments—which involve the removal of a patient’s cells, and then their re-insertion back into the patient’s body—qualify as a kind of “drug” that can be regulated by Washington, D.C., bureaucrats. But as we argue in our brief, the FDA isn’t supposed to be in the business of regulating the practice of medicine—and to interpret this treatment as a “drug” is to step far past the line Congress drew to limit federal power.
The FDA has authority to regulate “drugs”—that is, medicines that are bought, sold, and used in the United States—but it doesn’t have power to regulate the practice of medicine. That’s something states do, instead. Federal law defines “drugs” as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” The FDA has also adopted a rule called the “single surgical procedure” rule, which says that if a doctor removes a patient’s tissue on the operating table, treats it in some way, and then re-inserts it into the patient, that doesn’t qualify as the application of a new drug, and doesn’t need to be regulated by D.C. officials.
That makes sense. The reason the FDA was created over a century ago was to ensure that Americans knew what was in the medicines they were buying, selling, and using. It exists to prevent fraud or “mislabeling,” and Congress’s power to create the FDA comes from the Constitution’s “commerce” clause, which allows Congress to regulate the buying and selling of goods. But removing tissue from a patient on the operating table and putting it back into the patient is not buying and selling medicines or engaging in interstate commerce.
That might all sound academic, were it not for the invention of cutting-edge individualized medical treatments involving stem cells. These treatments, which show great promise for improving or even eliminating life-threatening conditions, are tailor-made for patients, because they involve taking a person’s own cells, treating them, and then re-implanting them back into the patient, where they can grow, spread, and even fix unhealthy tissues.
That’s not a drug, obviously—but in September the Ninth Circuit Court of Appeals ruled that such treatments fall within the FDA’s jurisdiction because under the “wide-ranging” legal definition of that term, the law applied to “an article derived mainly from human tissue and intended to treat … diseases.”
Of course, expanding the FDA’s authority in such a broad manner will stifle medical innovation and worsen the situation for patients—not to mention medical researchers—whose work might hold the key to the next breakthrough discovery. Federal drug approval is an expensive and slow process that can take over a decade and a half to obtain the go-ahead for even a single life-saving medicine.
Worse, as we argue in our brief, the decision intrudes on the right of medical autonomy—the right of every person to decide for him- or herself what medical treatments to take to improve or even save their lives. As we write in the brief, this principle of autonomy is a bedrock concept in medical ethics. It’s the patient’s life, and it should be the patient’s choice: “The most basic of all rights is the right to one’s own body. Indeed, the Due Process Clause even protects a person’s right to cut or not cut his own hair. If a patient has a constitutionally protected interest in something as trivial as a haircut, then she certainly has an interest in using her own body in an effort to defend herself against a disease; especially where, as here, the treatments involve an individual’s own unaltered cells to treat degenerative disorders that can be life-threatening.”
In fact, just last week, Goldwater Institute Senior Fellow Jeffrey Singer, M.D., discussed the principle of medical autonomy in an online conversation about his new book Your Body, Your Health Care:
We’ve asked the Supreme Court to take up this case, to enforce meaningful limits on FDA power, and to preserve the right of patients to defend and improve their own lives. You can read our brief here, and learn more about our work in defense of medical autonomy here.
