Dr. Robert Rifkin Rocky Mountain Cancer Centers Denver, CO September 26, 2011 Good Morning. I would like to thank the FDA for convening this timely workshop, and for the opportunity to address this important, vital and timely issues surrounding drug shortages. My name is Dr. Rob Rifkin and I am a medical oncologist and hematologist in Private Practice in Denver, Colorado. In addition, I am a member of the US Oncology Hematology Research Committee, and serve as the Medical Lead for the US Oncology Research Biosimilars Task Force. Today, I will address in my capacity as a member of the Executive Board of National Patient Advocate Foundation. I am here to address the current drug shortages on behalf of our patients. As the Chair of our institution’s Pharmacy and Therapeutics Committee, I am made aware on a daily basis of the tremendous numbers of drug shortages that we must face, and their potential impact on patient care. I would like to take this opportunity to highlight just a few of these. In the case of pediatrics, there has been a shortage of the simple amino acid cysteine which is a vital parenteral nutrient for our premature neonates. It is required to supplement their feedings to allow delivery of adequate calcium and phosphorous to promote bone mineralization. This amino acid is not currently available and is forcing pediatricians to make secondary, less effective, less safe and more costly substitutions to allow these premature infants to grow normally. In the case of medical oncology, I would like to share an example of a new female patient with colorectal cancer who is married to a physician and is herself an attorney. At the time of her colon resection, she was unable to receive proprofol to induce her anesthesia, an there was no succinylcholine to achieve muscle relaxation. Alternative agents were employed with satisfactory results. To make matters worse, she requires adjuvant therapy to maximize her chances for survival. Her preferred regimen is FOLFOX-6. As we have already heard, the 5-FU and Leucovorin which form an integral part of this regimen have been shorted as well. While Xeloda is available as an alternative to 5-FU, her copay for this oral agent is cost prohibitive. Levoleucovorin was also available as an alternative but as the time was not approved as an approved agent to treat her disease. On behalf of patients and physicians, these sorts of shortages are simply unacceptable in our great nation. The shortages are complex and multifactorial. in natures. In some cases there are shortages or raw materials, and in others there have been issues in the manufacturing process. Still other vital drugs are no longer viewed as profitable to make. I would ask the Agency to consider creating incentives whereby it is feasible to continue to manufacture generic drugs. The Agency is encouraged to take measures to improve patient and physician accessibility to vital drugs that serve as the backbones in evidence-based day-to-day medical practice. With the unique collection of stakeholders in this room, we should be able to solve a problem that did not exist 10 years ago. Furthermore, we should be able to communicate more effectively. In closing, as a practitioner and as a member of the National Patient Advocate Foundation Executive Board of Directors, I would like to express the frustrations that we feel as practitioners and for our patients. We urgently need to fix the system that has failed us in so many ways. Thank you…


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