Manufacturers Urged To Prevent Drug Shortages By Reducing Quality Risks
As the main cause of drug shortages is poor manufacturing quality, the best way to prevent them is to get ahead of the curve on quality, says a Pew/ISPE industry survey report.
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FDA's new commissioner, Scott Gottlieb, is looking to go beyond the agency's ad hoc responses to sterile injectables drug shortages and find ways to prevent such shortages by stirring up more competition under Hatch-Waxman. Meanwhile, manufacturers are looking for deeper commitments from group purchasing organizations to buy such drugs, which would enable greater investments in facilities and equipment.
Industry agrees FDA could help ameliorate drug shortages with quicker approval of new lines and relaxed enforcement, ISPE survey shows. There’s less enthusiasm for preventing shortages with backup contract manufacturers.
US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.