FDA Spotlights Recent Spike in Drug Shortages

Regulatory NewsRegulatory News | 27 November 2018 |  By 

The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages, according to agency presentations at an FDA/Duke Margolis Center for Health Policy event on Tuesday.

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.


These examples really underscore the challenges of anticipating and coping with long-lasting drug shortages, Rosenberg said.

FDA Commissioner Scott Gottlieb also 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.

Earlier this month, FDA announced it’s modernizing its inspection program for sterile injectables with an eye toward averting drug shortages.

Others at the event Tuesday also noted 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.

And FDA can also only do so much.


But 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.”

In terms of public health impact, Yoram Unguru of Children’s Oncology Group noted shortages have a lasting impact on clinical care and research.

Over a three-month period in the summer of 2016, he said three chemotherapies that are part of curative regimens became scarce, and earlier this year, two others that are necessary for nearly every type of childhood cancer also became scarce. He further explained that shortages for eight of the 10 drugs to treat acute lymphoblastic leukemia, which has a cure rate of over 90%, have been temporarily unavailable over the past decade.

Unguru called on FDA to create an essential medicines list to deal with such shortages.

Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions


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