Our second to last blog of this series will focus on the view of Pfizer Oncology. As mentioned previously, Pfizer manufactures both brand name and also generic injectable medications.
Pfizer Oncology was represented by Dr. Mace Rothenberg, MD who became the Senior Vice President of Clinical Development and Medical Affairs after more than 20 years of caring for people with cancer. Dr. Rothenberg has been very active with clinical trials throughout the various stages of drug development and his work was an integral part of the development of a number of chemotherapy medications used today. Dr. Rothenberg has been widely recognized for his work; being awarded the Lane W. Adams Quality of Life Award from the American Cancer Society and the American Society of Clinical Oncology’s Statesman Award, among other honors.
Dr. Rothenberg opened his talk with the implications of drug shortages which include frustration for the doctor, challenges to the hospital organization as they try to secure supply, medication errors (as we previously noted), delays in clinical trials, and most importantly stress and anxiety for patients and their loved ones.
Like the other speakers, Dr. Rothenberg noted the multiple causes that contribute to the problem. His list included the quality of raw materials, manufacturer financial decisions, FDA regulation, small inventory, gray market price gouging, stockpiling, and changes in clinical practice including emergencies. We have reviewed most of these earlier with the exception of stockpiling which leads to supply sitting on a shelf instead of being used for patients.
Rothenberg reminded us of the economic factors previously discussed then moved into the discussion about Pfizer’s solution. Pfizer has historically been a manufacturer of only branded medications (add link to their product list website) but Pfizer has taken the opportunity to think about ways in which they could help meet the growing demand of the generic marketplace. Dr. Rothenberg spoke to the fact that the original strategy was to produce generic versions of Pfizer drug that had experienced patent expiration, but moved into manufacturing other medications given the shortages. One might assume that Pfizer could use its current operations with some updates to surplus to match the economy of the generic profit margin to produce quality medicines while still securing a profit.
Rothenberg showed a visual of their manufacturing facility in Perth, Australia which he says has had a 98% ‘in stock’ for the 80 countries it serves (in 2011) and its current U.S. ‘in stock’ has been 100% since 2011. Pfizer is currently manufacturing 9 generic chemotherapy drugs and they have applications in to the Food and Drug Administration to add to their list. It was stated that the current wait time to get an application to manufacture a new generic medication is between 24 and 30 months. As you can imagine, that wait time to get medications to the market is a concern. I will note here that during Dr. Kweder’s talk, she did note that if there is a critical shortage, the FDA has pulled an application out of submission order to speed up its review.
As with the other speakers, Dr. Rothenberg noted the complexity of the issue along with potential solutions which we will review in the final blog entry.