What if physicians could use genetic tests to tailor prescriptions to their patients’ individual genotypes? Physicians and pharmaceutical companies can use pharmacogenomics to decrease the number of adverse drug reactions, increase drug efficacy, and lower health care costs. Unfortunately, cross-labeling rules serve as both legal and policy hurdles for these advances, hurdles the FDA has the power to remove. Part I explains pharmacogenomics and why it currently has a narrow application. Part II discusses the FDA's regulatory approach to pharmacogenomics. Part III explains the legal and policy hurdles of cross-labeling and how they impede the more widespread use of pharmacogenomics. Part IV examines ways to clear the legal cross-labeling hurdles while Part V examines ways to clear the policy cross-labeling hurdles. Finally, Part VI discusses some of the many other complex legal and policy issues that lawmakers, regulators, and the industry will need to resolve in order to realize the full potential of pharmacogenomics.

Refusals by individual pharmacies and pharmacists to fill prescriptions for emergency contraceptives (“EC”) have dominated news headlines, from the Washington Post to the Miami Herald. In the act that sparked a firestorm of controversy, an Eckerd pharmacist refused to fill a rape victim’s prescription for Plan B. A few months later, 11 Alabama nurses resigned positions at state clinics rather than provide EC against their moral convictions. These refusals do not seem to be driven by moral concerns about promiscuity, since pharmacists have refused to dispense Plan B to married couples as well. Instead, the refusals reflect moral and religious concerns about facilitating an act that would cut-off a potential human life.

Merck’s recently released vaccine, Gardasil, may revolutionize cervical cancer prevention. With the rate of detected cervical cancer cases and associated deaths rising rapidly, cervical cancer is a major public health concern. Infection with the human papillomavirus, a sexually transmitted disease, is a necessary cause of cervical cancer. Gardasil protects against two specific “high risk” strains of HPV, associated with about 70% of cervical cancer cases, and blocks infection by two other strains of HPV, responsible for 90% of genital warts cases. Proponents of Gardasil believe that vaccination of women between the ages of 12 and 26 can slow the spread of cervical cancer by eradicating the two major HPV strands associated with the cancer’s development.