The United States Food and Drug Administration has had a formal process for authorizing patients with life-threatening illnesses to access unapproved or experimental drugs outside of clinical trials since the 1980s. Recently states have begun enacting “Right to Try” laws that allow patients to request drugs that have passed phase 1 trials directly from the manufacturer, attempting to bypass the FDA. In two August 25 articles in the American Society of Clinical Oncology (ASCO) Post, “Right to Try Laws: Helpful or Harmful” and “Johnson & Johnson Creates Independent Bioethics Panel to Evaluate Compassionate Drug Use Requests,” Professor Patricia J. Zettler explains that the state laws have no effect because federal law preempts state law and the FDA’s process must be followed. She also discusses how these state laws can be confusing and even harmful, even if the policymakers intentions are good, because they lead patients to believe they will be able to obtain treatments that are not available to them.
Patricia J. Zettler is an associate professor at Georgia State University College of Law this fall and was a former attorney with the Food and Drug Administration. Zettler’s research focuses on the regulation of medicine, biotechnology, and biomedical research, as well as food and drug policy.