What’s new at FDA?
The United States Food and Drug Administration is a large organization that changes daily. From the perspective of homeopathic companies, a few important things stand out.
FDA published the final version of its homeopathic guidance in December 2022. AAHP commented as follows: The final guidance changed very little from the revised draft published in October 2019. Originally published in December 2017, the guidance has come to include several recommendations that AAHP submitted as comments to FDA. AAHP believes many of the agency’s assertions, policy choices, legal arguments, and conclusions in the final guidance are incorrect, and we look forward to working with FDA in the future on gaps and opportunities in the regulation of homeopathic drug products.
There were also two notable retirements from FDA: Don Ashley, J.D., retired from FDA on Nov. 23, 2022. Mr. Ashley served as Director of FDA’s CDER Office of Compliance. In that role, he oversaw enforcement actions across CDER’s product portfolio, including homeopathic drug products. Mr. Ashley engaged with AAHP several times on enforcement matters with AAHP regarding homeopathic drug products. During those conversations, he was candid and clear. In addition, Mr. Ashley was a frequent presenter on enforcement actions against homeopathic products at other industry events. He served for 18 years at the Department of Justice prior to joining FDA. Mr. Ashley’s position has been filled on an Acting basis by Jill Furman.
Richard (Rik) Lostritto, Ph.D., retired from FDA’s Office for Pharmaceutical Quality (OPQ). Dr. Lostritto served in the role of Associate Director of Science at FDA’s CDER/OPQ/Office of Policy for Pharmaceutical Quality. In that role, he worked on developing and clearly communicating science and risk-based policies and standards related to drug product quality, including application review and inspection. Dr. Lostritto was a frequent presenter at AAHP and HPCUS meetings. His insights expressed at those presentations have been invaluable to our efforts to improve product quality among AAHP members. Before joining FDA, Dr. Lostritto worked as a scientist in the pharmaceutical industry and as a professor at the University of Connecticut School of Pharmacy. His replacement has not yet been named.
Last, we highlight Robert M. Califf, M.D., the FDA Commissioner. Nominated to head FDA by President Joe Biden, Dr. Califf was sworn in on Feb. 17, 2022. This is Dr. Califf’s second time serving at FDA, as he was previously Commissioner of Food and Drugs from February 2016 to January 2017. As the FDA top official, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote public health. (See more in AAHP previous article, “Meet the Incumbent FDA Commissioner, Robert Califf, MD,” published February 2022.)
We thank these three gentlemen for their long and productive service to public health.