FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Drug Shortage Task Force Finds ‘A Broken Marketplace,’ Say Sharpless, Woodcock

Nov. 8, 2019
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A key cause of U.S. drug shortages is the market’s failure to reward well-developed quality management systems, according to an analysis by an FDA-led interagency task force.

In a 124-page report, the task force identified the root causes of U.S. drug shortages and offered potential solutions, including a quality rating system to reward facilities with highly developed management systems.

Current good manufacturing practice (CGMP) regulations only set a minimum bar for companies, and the focus on CGMP compliance means many drugmakers don’t establish advanced quality management systems to deal with problems before they occur, the task force said.

The report also cites two other key causes of shortages — a lack of incentives for producing less lucrative drugs, and logistical and regulatory hurdles drugmakers face when increasing drug production.

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