FDA spotlights recent spike in drug shortages

Matthew Rosenberg, an economics staffer at FDA, recently examined the extent of drug shortages based on FDA archives and the IQVIA national sales database. He found that ongoing shortages have become more prevalent over the last year or so, and in terms of duration there are more persistent shortages now than was previously the case.

Matthew Rosenberg, an economics staffer at FDA, recently examined the extent of drug shortages based on FDA archives and the IQVIA national sales database. He found that ongoing shortages have become more prevalent over the last year or so, and in terms of duration there are more persistent shortages now than was previously the case. In terms of intensity, more than two-thirds of historical volumes have typically been unavailable for these drugs. FDA Commissioner Scott Gottlieb notes that many of the critical drugs in shortage are sterile injectable drugs, and most of these drugs are longtime, generic medicines that are relatively inexpensive. Experts add that buyer and seller consolidation, along with low margins and contracting practices, can contribute to drug shortages. There are also markets where the prices may be too low to sustain reliable supply and the necessary investments in manufacturing, according to Gottlieb. The Association for Accessible Medicines points out that FDA can influence changes around improving the existing expedited resolution pathway for drugs in shortage. "AAM believes FDA should permit generic sponsors to comply with new or updated standards as a post-market commitment to mitigate delays in access," AAM said. "New cGMP requirements and or enhancements to cGMP requirements should be provided via guidance rather than via 483s or warning letters."