Washington, D.C. – Today, U.S. Representative John D. Dingell (D-MI15) released the following prepared opening statement at the House Committee on Energy and Commerce Subcommittee on Health hearing entitled, “Examining the Increase in Drug Shortages.”
“I thank the Chairman for holding today’s important hearing. Over the last six years the number of drug shortages has nearly tripled, resulting in hospitals, pharmacies, providers and patients scrambling for the drugs they need. The headlines of this summer speak volumes:
• “Drug shortages threaten patient care,”
• “Drug shortages set to reach record levels,”
• “Shortage of key hospital drugs a ‘major crisis’,”
• “Drug prices soar as hospital suppliers are forced into ‘Gray Market’,” and,
• “Dangers of worsening drug shortages; remedy unavailability could start costing American lives.”
“This is not an isolated problem. Shortages are affecting hospitals from Detroit to Nashville to Houston. In a survey by the American Hospital Association, three out of four hospitals reported rationing or restricting the drugs in short supply. More than 80 percent reported delaying treatment and nearly 70 percent had to substitute less effective treatments for their patients.
“These numbers are astounding. For patients needing certain treatments they could be at risk of having their drugs rationed, restricted, or substituted for a less effective treatment. This is absolutely unacceptable, and Congress and the federal government cannot sit idly by and allow this problem to worsen.
“We know that there are many different issues that can cause a drug shortage - availability of raw materials, the complexity of manufacturing certain treatments or sudden unexpected increases in demand. But at the end of the day the ultimate impact of these shortages is potentially deadly, causing patients to go without care or, even worse, turn to the gray market to purchase the life-saving drugs they need. An active, unregulated gray market has resulted in consumers, pharmacists and hospitals purchasing potentially ineffective, contaminated, counterfeit or adulterated products.
“I hope that today’s hearing will help the Committee and its Members to understand the problem at hand, learn about the causes of the problem, and help to explore ways that Congress, the Department of Health and Human Services and the Food and Drug Administration can make improvements to minimize the impacts drug shortages are having on patient care, and ensure the quality of drugs in our Nation’s supply is not comprised.”
Congressman Dingell has been a longtime advocate of ensuring the quality of drugs in our Nation’s supply chain. This past April the Congressman introduced legislation that would provide FDA with the authorities and resources it needs to hold foreign manufacturers to the same safety and efficacy standards as domestic companies. Please review the release from April to learn more about H.R. 1483, the Drug Safety Enhancement Act. To view a video of Congressman Dingell questioning HHS Assistant Secretary Koh earlier today, click here.
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