Prof. Patti Zettler was quoted in the Saint Louis Dispatch article “Mallinckrodt takes on FDA in fight over ADHD generic” on the Food and Drug Administration’s process of approving generic drugs. FDA’s studies have shown that Mallinckrodt’s generic version of Concerta, a popular ADHD drug, delivers the medication at a slower rate than the brand name drug, and the FDA re-classified it so that pharmacists can’t fill Concerta prescriptions with Mallinckrodt’s generic. Mallinckrodt is now fighting back, arguing that the re-classification has essentially pulled the drug from the market and that they are entitled to due process and a hearing. If Mallinckrodt is successful, Zettler states, the FDA will face a much more time and resource consuming process for reclassifying drugs.
Patti 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.