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Management Issue 8:
Protecting Consumers of Food, Drugs, and Medical Devices

Why This Is a Challenge

The Department, through the Food and Drug Administration (FDA), is responsible for protecting the public's health by ensuring the safety, efficacy, and security of drugs, medical devices, biologics, and much of our Nation's food supply. The Department must ensure that once a drug, biologic, or device has been approved for use, it is marketed appropriately. During a food emergency, the Department is also responsible for finding the contamination source and overseeing the removal by manufacturers of these products from the market. However, OIG work has revealed weaknesses in FDA's ability to adequately oversee the safety of drugs, biologics, medical devices, and food. These challenges include:

Inadequate Food Facility Inspections and Recordkeeping. OIG found that FDA was conducting food facility inspections infrequently many food facilities went 5 years or longer without an FDA inspection. FDA took action against less than half of food facilities after the agency found conditions that warranted its most severe inspection classification. FDA relies upon States to conduct food facility inspections under contract; however, FDA has failed to ensure that States completed all required inspections, that the completed inspections were properly classified, or that all violations were remedied.

Similarly, food facilities' failure to comply with FDA's recordkeeping requirements impedes the Department's ability to ensure the safety of the Nation's food supply. We found that 59 percent of selected food facilities did not comply with FDA's recordkeeping requirements. Additionally, in reviews of food safety recalls, we found that FDA often did not follow its own procedures for ensuring that the recall process operated efficiently and effectively. Further, FDA's procedures for monitoring recalls were not always adequate.

Ensuring Compliance With Marketing Requirements. Manufacturers of drugs, biologics, and medical devices gain approval for sale of their products for specific uses once FDA determines that the products are safe and effective for those uses. Once these items are approved for sale, qualified medical providers may prescribe them for any uses on the basis of their medical judgment. However, manufacturers are prohibited from promoting products for uses for which FDA has not specifically approved them (known as off-label uses). OIG works with its law enforcement partners, including FDA's Office of Criminal Investigations, and has investigated many instances in which manufacturers have illegally promoted products for off-label uses. Off-label promotion can undermine the system intended to ensure that drugs are safe and effective and can put patients at risk. FDA faces ongoing challenges in adequately monitoring and preventing illegal off-label promotional activities. Additionally, illegal off-label promotion may increase fraudulent claims for payment submitted to Federal health care programs, including Medicare and Medicaid.

Inadequate Procedures and Monitoring. OIG has found vulnerabilities in FDA's oversight of regulatory decisions and monitoring of drugs and medical devices. For example, OIG found weaknesses in FDA's management of internal scientific disagreements related to regulatory decisions for medical devices under agency review. Other concerns include weaknesses in ensuring the adequate monitoring of adverse-event reporting for medical devices and the accuracy of FDA's National Drug Code Directory.

OIG is reviewing FDA's progress in reclassifying high-risk devices cleared under the 510(k) process. OIG is also reviewing FDA's monitoring of the Risk Evaluation and Mitigation Strategies (REMS) that sponsors are required to submit for drugs associated with known or potential risks that may outweigh a drug's benefits.

Progress in Addressing the Challenge

In September 2009, FDA required food facilities to report to a new registry all instances when there is a reasonable probability that a food might cause serious adverse health consequences and to investigate the causes of any adulteration reported if the adulteration may have originated with the food facility. The Food Safety Modernization Act (FSMA), signed into law in January 2011, provides FDA important new authorities to better protect the Nation's food supply.

OIG will continue to oversee the Department's management of food safety issues and FSMA implementation. In ongoing work, OIG is examining whether the structure/function claims made by manufacturers of dietary supplements may be misleading to consumers and whether dietary supplement companies have registered as required with the Food Facility Registry so that FDA may contact companies in an emergency.

OIG is working with law enforcement partners to investigate and prosecute drug and device manufacturers that engage in illegal activity. For example, GlaxoSmithKline recently agreed to plead guilty to misbranding charges, pay more than $3 billion in criminal fines, enter into a civil settlement, and enter into a corporate integrity agreement with OIG to resolve criminal, civil, and administrative liability resulting from various types of conduct, such as unlawful promotion of certain drugs and failure to report safety data on a particular drug to FDA. In November 2011, Medtronic, Inc., agreed to pay $23.9 million to resolve allegations under the Civil False Claims Act that it caused false claims to be submitted to Medicare and Medicaid by inducing doctors to implant the company's pacemakers and defibrillators in patients in exchange for payments to those doctors.

What Needs To Be Done

The Department and FDA will need to focus on implementing the new Food and Drug Administration Safety and Innovation Act, which was signed into law in July 2012. In addition, FDA will need to continue its efforts to fully implement FSMA to better protect the Nation's food supply. FSMA addresses many of OIG's recommendations; however, we continue to recommend that FDA vigorously use its new authorities to remedy identified weaknesses in its inspections and recall procedures. FDA should also ensure that States properly conduct contracted food facility inspections.

The Department also needs to focus on eliminating off-label promotion to protect patients and HHS health care programs.

Key OIG Resources

Management Issue 9: Integrity and Security of Health Information Systems and Data

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Office of Inspector General, U.S. Department of Health and Human Services | 330 Independence Avenue, SW, Washington, DC 20201