Michigan Senator Raises Concerns With FDA Over High Numbers of Drug Shortages

Regulatory NewsRegulatory News | 21 August 2019 |  By 

As drug shortages continue to increase in the US, Sen. Gary Peters (D-MI) on Wednesday sent a letter to Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless seeking more information on what FDA will do.

Peters, ranking member of the Committee on Homeland Security and Governmental Affairs, called FDA’s current efforts to combat shortages “not sufficient, given the current state of rising drug shortages in our nation.” He also wrote that he’s “increasingly concerned” that FDA may not have the data necessary to sufficiently assess and mitigate shortages. 

“New and active drug shortages in the United States are at their highest levels in almost five years,” Peters wrote. “The number of active shortages in the first half of 2019 alone, 282, already exceeds the number of active shortages at any point in 2018 according to the American Society of Health-System Pharmacists (ASHP).”

As far as examples, Peters points to a shortage of intravenous immune globulin (IVIG) that has resulted in rationing and the cancellation of infusions for some patients. The Wall Street Journal recently published an article on the IVIG shortage, noting how some hospitals and infusion clinics have begun rationing immune globulin (IG) products.

For its part, FDA’s Center for Biologics Evaluation and Research said it is working closely with the applicants/manufacturers of IG products and is “working with industry in exploring ways to improve the manufacturing yield of IG products, which are derived from donor plasma.”  
Peters also cited a 2019 report by the National Opinion Research Center (NORC) at the University of Chicago that found 80% of the almost 4,000 community hospitals surveyed said drug shortages contributed to a significant increase in spending.
Moving forward, Peters wants FDA to provide information on actions taken as a result of the 27 November 2018 public meeting to address root causes of drug shortages. He also wants more information on how FDA will continue to allow imported drugs from foreign markets to address shortages. And he seeks more information on what manufacturers voluntarily provide to FDA as part of efforts to address underlying causes of shortages.
FDA Drug Shortages


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