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DeLauro Proposal Would Close Dangerous Gap in FDA Regulatory Authority

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Today, U.S. Rep. Rosa DeLauro (D-Conn.) introduced legislation that would give the U.S. Food and Drug Administration (FDA) the authority to order emergency recalls of medications that present an imminent threat to the health of patients.

Public Citizen applauds Rep. Rosa DeLauro for introducing commonsense legislation that would finally give the FDA the authority to order recalls of potentially tainted medications that pose an unacceptable health risk to patients.

Most people would be shocked to learn that while the FDA has the authority to order a recall of medical devices and biologic products, such as vaccines and blood products, the agency cannot order recalls of prescription and over-the-counter medications. As a result, the agency lacks sufficient means to protect patients from potentially dangerous medications that already have been distributed to pharmacies, doctors and patients. In recent years, Public Citizen has been tracking a handful of irresponsible manufacturers that have taken advantage of this gap in FDA authority by refusing the agency’s calls for voluntary recalls of potentially contaminated products.

DeLauro’s bill would close this safety gap and provide the FDA with an essential tool to better protect public health. We urge Congress to pass this legislation as quickly as possible.