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.

Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.