190th Podcast Interview: the FDA's Captain Valerie Jensen Discusses Remedying the Drug Shortage Problem (November 20th)
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Listen Now On October 31st, the FDA released the agency's Congressionally-mandated report titled, “Drug Shortages: Root Causes and Potential Solutions.” The 124-pg report found drug shortages are increasing, persistent, i.e., the duration longer, with both the intensity and public health impact high. These shortages can, the FDA found, “have a devastating effect,” by prolonging patient suffering, contributing to disease progression & increased morbidity. Concerning root causes, the FDA found market consolidation has caused current contracting practices to constitute in sum a “race to the bottom.” The FDA also found the market also fails to recognize or reward manufacturers for mature quality management systems and found a market that is unable to quickly recover after a disruption in either manufacturing or supply chain distribution. Despite the worsening drug shortage problem, and the Congress’ considerable focus on drug pricing legislation this year, not a single drug shortage committee hearing was held this Congressional session or this year. (Listeners may recall I posted in August a related essay I wrote on this topic for STAT).
190th Podcast Interview: the FDA's Captain Valerie Jensen Discusses Remedying the Drug Shortage Problem (November 20th)
190th Podcast Interview: the FDA's Captain…
190th Podcast Interview: the FDA's Captain Valerie Jensen Discusses Remedying the Drug Shortage Problem (November 20th)
Listen Now On October 31st, the FDA released the agency's Congressionally-mandated report titled, “Drug Shortages: Root Causes and Potential Solutions.” The 124-pg report found drug shortages are increasing, persistent, i.e., the duration longer, with both the intensity and public health impact high. These shortages can, the FDA found, “have a devastating effect,” by prolonging patient suffering, contributing to disease progression & increased morbidity. Concerning root causes, the FDA found market consolidation has caused current contracting practices to constitute in sum a “race to the bottom.” The FDA also found the market also fails to recognize or reward manufacturers for mature quality management systems and found a market that is unable to quickly recover after a disruption in either manufacturing or supply chain distribution. Despite the worsening drug shortage problem, and the Congress’ considerable focus on drug pricing legislation this year, not a single drug shortage committee hearing was held this Congressional session or this year. (Listeners may recall I posted in August a related essay I wrote on this topic for STAT).