FDA looks at incentives, manufacturing ‘interventions’ to solve drug shortages

The FDA will consider creating a list of “essential drugs” and financial incentives to drugmakers that manufacture them as it continues to grapple with the drug shortages that plague U.S. hospitals and caregivers.  

Responding to lawmakers’ entities to find new solutions to an old problem, FDA Commissioner Scott Gottlieb, M.D., last week announced the formation of a new Drug Shortages Task Force and named Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives to lead it.

“I’m charging the shortages task force to delve more deeply into the reasons why some shortages remain a persistent challenge,” Gottlieb said. “The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these shortages.”

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The new strategy comes as drug shortages are again on the rise. After five years of declines in the number of new drug shortages in the U.S., they jumped to 39 last year from 26 in the two preceding years. And while that is a far cry from the peak of more than 250 registered in 2011, the FDA acknowledges that many of the current shortages have been for critical drug products and “are having a tangible impact on patients.”

It also follows a letter last month from a bipartisan group of senators that asked Gottlieb to provide recommendations to Congress on how to address nationwide drug shortage. The senators last week applauded the new task force.

Drug shortages have been a problem for providers for years. In the announcement last week, the commissioner pointed out that because margins on many generic sterile injected drugs are slim, while manufacturing standards are very high, production has been concentrated in fewer large-scale facilities. Production interruptions at those facilities can significantly affect supplies.

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He said the task force will also be exploring “manufacturing issues.” The FDA is already taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur.

Further, he said, the FDA may want to consider “more significant interventions” than it currently employs. “We want to make sure we aren’t discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals." One suggestion is to grant the FDA authority to require applicants of certain drugs to conduct a “risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage," and to establish risk mitigation plans in advance to address those weaknesses.