The US Food and Drug Administration (FDA) is working to update its approach to drug shortages after several high-profile manufacturing-related shortages over the last year. In a blog post, FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock described some of the challenges facing the agency and its plans for addressing those challenges.
“Ensuring that a necessary drug is available to a patient involves a lot of stakeholders working together at key stages of the development, manufacturing, marketing, and distribution of a medicine,” Gottlieb and Woodcock write.
FDA on Shortages
The FDA recently held a public meeting on the issue entitled “Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.” Regulatory Focus reported on the event. As they noted, Matthew Rosenberg, an economics staffer at FDA, looked at drug shortages in terms of occurrence, duration, intensity and public health impact. Combining data from FDA archives and IQVIA national sales database, Rosenberg found ongoing shortages have become more prevalent over the last year or so, 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 and the public health impact is also high.
FDA Commissioner Scott Gottlieb noted that many of the critical drugs in shortage are sterile injectable drugs, and most of these drugs are old, generic medicines that are relatively cheap. Others at the event said that buyer and seller consolidation, in addition to 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, Gottlieb added.
The generic drug industry group, Association for Accessible Medicines, noted 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.”
You can watch more here from the event.