The People's Pharmacy - Comment

We are commenting on behalf of consumers, physicians, pharmacists and other health care providers. Joe Graedon, MS, is a pharmacologist and Teresa Graedon, PhD, is a medical anthropologist. We write a syndicated newspaper column, host a health-talk show syndicated on public radio and are founders and directors of the website www.PeoplesPharmacy.com. Many people who write to us, listen and visit our website are concerned about oversight of generic drugs. A great many have lost faith in the quality of generic drugs and the ability of the FDA to ensure public safety with respect to generic drugs. We urge the FDA to take the following actions: 1) Develop a definition of bioeqeuivalence that can be understood by health professionals and patients alike. If that is impossible, the FDA must develop new standards and regulations that are comprehensible and adequate to ensure identical clinical activity. 2) Incorporate T-max and dissolution data into the formal consideration of generic drug bioequivalence. 3) Make all bioequivalence curves available for public scrutiny. Without such transparency, faith in the generic drug approval process will be further eroded. 4) Demand unannounced inspections of all manufacturing and generic drug research facilities. Overseas companies that wish to export their products (generic drugs, APIs, and inactives) to the U.S. must be willing to submit to such unannounced inspections. Our full comments are attached along with bioequivalence curves and dissolution data for Budeprion XL 150 vs. Wellbutrin XL 150. Submitted by Joe Graedon, MS, & Teresa Graedon, PhD, June 6, 2013