The Food and Drug Administration is forming a new task force to focus on why the U.S. has so many drug shortages, and what solutions may be possible.
Though the regulator has made progress in addressing shortages, “we must work to find new and creative ways to tackle the issue,” Commissioner Scott Gottlieb said Thursday.
New drug shortages have declined in recent years, particularly since 2011, when 250 new shortages were reported, but they “continue to pose a real challenge to public health,” according to an FDA report. “This is especially the case when a shortage involves a critical drug to treat cancer, to provide parenteral nutrition, or to address another serious medical condition, such as the shortage of intravenous saline solution.”
High-profile drug shortages in the last few years have included injectable painkillers, IV fluids and, most recently, EpiPens.
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The FDA initiative, called the Drug Shortages Task Force, will be led by Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives, and will include representatives of the FDA, Centers for Medicare and Medicaid Services and the Department of Veterans Affairs.
Last year, drug production issues in the wake of Hurricanes Harvey, Irma and, particularly, Maria, resulted in new shortages and added to existing ones, the FDA report said.
In particular, generic medicines have low margins, and because of industry consolidation, errors can have significant consequences, Gottlieb said.
Solutions might include encouraging manufacturing investments for generic medications, re-evaluating reimbursement for certain drugs and creating a “critical drugs list” of products that are especially important to have in supply, he said.
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