Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages
Authors Janet Woodcock and Marta Wosinska of FDA explore why and how these shortages may have been created. From the abstract: “The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments. The US Food and Drug Administration’s (FDA’s) need to use its regulatory flexibility, on behalf of patients, to avoid shortages of medically necessary drugs may further strengthen the incentive to “push the envelope” on quality. These dynamics may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.”
See DIA's Content Currents EDITION PUBLISHED: APRIL 12, 2013 for more new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
Authors Janet Woodcock and Marta Wosinska of FDA explore why and how these shortages may have been created. From the abstract: “The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments. The US Food and Drug Administration’s (FDA’s) need to use its regulatory flexibility, on behalf of patients, to avoid shortages of medically necessary drugs may further strengthen the incentive to “push the envelope” on quality. These dynamics may have produced a market situation in which quality problems have become sufficiently common and severe to result in drug shortages.”
See DIA's Content Currents EDITION PUBLISHED: APRIL 12, 2013 for more new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.
Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
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