House committee to investigate FDA's response to ongoing drug shortages

28 Mar 2023
endpts.com
Republican leaders of the House Committee on Energy & Commerce sent a five-page letter yesterday announcing an investigation into the ongoing drug shortages that have rankled the US during the pandemic and the FDA’s response to it. The letter, signed by Chair Cathy McMorris Rodgers (R-WA), explains how shortages have become more common over the past decade, while pointing to a report from the National Academies of Science, Engineering and Medicine finding that drug shortages have been “on the rise” over the past several decades and are lasting longer, with new drug shortages in the US seeing a 30% increase from 2021 to 2022. However, the committee’s letter writes that it is “not clear” that the FDA is using some of its existing authorities to mitigate the shortages. The letter points to the CARES Act provision that required manufacturers to report the volume of each drug produced, prepared or processed for distribution on an annual basis and where active ingredients and finished doses were made — helping to pinpoint where the vast majority of the drugs are made. “It is not clear to this Committee what the FDA has done with the new data. To date, the FDA has not publicly released any summary of these reports in an aggregated way that may inform policy makers and provide the data Congress and others need as we examine ways to make sure the supply chain for drugs Americans need is secure,” the letter says. To assist the committee in oversight, it is asking the FDA to respond to several questions including with reports on the total “aggregated amount” of each listed drug reported for the calendar years of 2020 to 2022. This includes the country of origin and whether it is listed in the shortage database among other details. Other questions include how information that is received is being used to inform its inspection priorities and curb shortages and who has failed to report information on drug amounts. The committee is also asking for information on the shortage of specific drugs such as Pluvicto , Bacillus Calmette-Guerin (BCG) vaccine, amoxicillin , acetaminophen, ibuprofen and the cancer drugs: fluorouracil, cisplatin and methotrexate . “We are pleased to see Congress’ attention focused on the ongoing shortages of critical medications plaguing our healthcare system. Congress can do more to improve purchaser visibility into data reported to the FDA so that hospitals and pharmacies to source products from manufacturers with secure and reliable supply chains,” said Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, in a statement to Endpoints News. Endpoints also reached out to the FDA but did not receive a response by press time. In addition to this investigation, on the Senate side last week , the Committee on Homeland Security and Governmental Affairs held a hearing on drug shortages with experts offering various solutions to the current and possibly future shortages.
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