Paul Schwartz was honored with the highest award given by the Association of Accessible Medicines, the lifetime achievement award. Paul came to the FDA two years after I started in 1984 and after his decades of service with the FDA, he recently retired from the Agency as the Director, Division of Postmarketing Assessment II, in the Office of Product Quality.
Paul was always a voice of reason in the Generic Drug program over his entire career. Not only did he truly believe in the FDA mission, but he also believed that the FDA and industry were partners in assuring that the American public had access to safe and effective lifesaving medications. Paul’s work epitomized what we all hope people will think of us when we leave a long career. In his last assignment, he built a team that reduced the backlog of pending supplements and moved the important changes in drug products that were needed by industry, for a change in FDA requirements, or changes in official compendia efficiently through the review and approval process. Paul was responsible for expediting thousands of supplements that helped alleviate drug shortages, as well as implementing supplemental changes when circumstances were beyond a company’s control, or were necessary for specific public health issues or initiatives. He made himself personally available to respond to questions from sponsors, provided advice to industry, and worked together with other FDA components. You could always count on his advice and counsel.
Iilun Murphy, M.D., Director Office of Generic Drugs, noted in her speech earlier in the conference that supplements have been a very large part of the Generic Drug workload and have created a stream of work that has driven OGD output over the last few years as new ANDA submissions have fallen over that period of time. Once the backlog was cleared, Paul’s team kept up with the rapid flow of supplemental changes, providing industry an assured pathway for making necessary manufacturing or quality changes.
Paul noted at the end of his speech “that if receiving this award really meant that I really have helped industry, FDA and the American public then I guess it was a career well spent.” In our view it sure was Paul! Best of luck to you in this next chapter of your life and illustrious career. We in industry thank you!
