Management Challenge 10:
Ensuring the Safety of Food, Drugs, and Medical Devices
Why This Is a Challenge
The Department, through the Food and Drug Administration (FDA), is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, medical devices, biologicals, 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:
Limited oversight of drug safety. A fall 2012 nationwide meningitis outbreak caused by contaminated injections raised major concerns about the use of drugs supplied by compounding pharmacies. OIG reviewed hospitals' use of compounded drugs and found that in 2012, 92 percent of hospitals used compounded sterile preparations (CSPs). Additionally, we found that 56 percent of hospitals made changes or planned to make changes to CSP sourcing practices in response to the fall 2012 meningitis outbreak. In recent congressional hearings about vulnerabilities in the oversight of compounding pharmacies, FDA has raised concerns that its enforcement authority might not be sufficient to take action against inappropriate compounding practices.
Similarly, OIG's review of Risk Evaluation and Mitigation Strategies (REMS) raised concerns about FDA's monitoring of the risks associated with drugs that have known or potential risks that may outweigh the drugs' benefits. REMS are enforceable, structured plans to manage specific risks associated with these drugs. We found that nearly half of sponsor assessments for the REMS we reviewed did not include all information requested in FDA assessment plans. Moreover, FDA does not have the authority to take enforcement actions against drug sponsors that do not include all information requested in FDA assessment plans.
Inadequate food facility and dietary supplement manufacturer recordkeeping. In the past, OIG have found that 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. OIG found that 59 percent of selected food facilities did not comply with FDA's recordkeeping requirements. In recent reviews of manufacturers of dietary supplements, OIG found that 28 percent of contacted companies failed to register with FDA as required. Of the companies that did register, 72 percent failed to provide the complete and accurate information required in the registry.
Potentially misleading claims made by manufacturers of dietary supplements. The Government Accountability Office (GAO) and public interest groups have raised concerns about a specific type of claim called a structure/function claim that manufacturers may use on dietary supplement labels. Manufacturers have used these claims to promote health benefits of their products. Stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support. Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to FDA, and FDA has only voluntary standards for it. A manufacturer must notify FDA when it uses structure/function claims. OIG found that substantiation documents for the supplements reviewed were inconsistent with FDA guidance on competent and reliable scientific evidence. OIG also found that FDA could not readily determine whether manufacturers had submitted the required notification for their claims. These results raise questions about the extent to which structure/function claims are truthful and not misleading.
Ensuring Compliance With Marketing Requirements. Manufacturers of drugs, biologicals, 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 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, in conjunction with its law enforcement partners, including FDA's Office of Criminal Investigations, has investigated many instances in which manufacturers 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. Additionally, this illegal off-label promotion may lead to fraudulent claims for payment submitted to Federal health care programs, including Medicare and Medicaid. FDA faces ongoing challenges in adequately monitoring and preventing illegal off-label promotional activities.
Progress in Addressing the Challenge
Since September 2009, FDA has 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.
The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in July 2012, expands the FDA's authorities and strengthens its ability to safeguard public health by authorizing the collection of user fees to fund reviews of drugs and devices; promoting innovation to expedite the development and review of certain new drugs; increasing stakeholder involvement in FDA decision making; and enhancing the safety of the drug supply chain. FDA has established a 3-year plan to implement these provisions, and the agency's progress is updated monthly on a website.
OIG is continuing to work with law enforcement partners to investigate and prosecute drug and device manufacturers that engage in illegal activity. This year, as in past years, the Government entered several settlements with drug and device manufacturers relating to alleged off-label promotion. For example, in December 2012, Amgen Inc. agreed to pay a total of $762 million to resolve allegations of off-label promotion and other improper conduct. Amgen pled guilty to misdemeanor misbranding charges, entered a civil settlement agreement, and entered a comprehensive corporate integrity agreement with OIG to resolve its criminal, civil, and administrative liability for the improper conduct. In July 2013, TranS1, a medical device manufacturer, agreed to pay $6 million to resolve allegations under the False Claims Act that it caused false claims to be submitted to Medicare and Medicaid by, among other things, promoting its medical device for uses not approved or cleared by the FDA.
FDA has made progress in addressing OIG recommendations. For example, as a result of OIG's identifying vulnerabilities in FDA's oversight of regulatory decisions, FDA implemented new operating procedures for resolving scientific disagreements. However, other concerns raised by our office, such as weaknesses in ensuring the adequate monitoring of adverse-event reporting for medical devices and the accuracy of FDA's National Drug Code Directory, remain unaddressed.
What Needs To Be Done
The Department and FDA will need to continue issuing the rules and guidance documents necessary to fully implement the various provisions in FDASIA. 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
- OIG reports on food facility safety inspections (December 2011), structure/function claims by dietary supplements (October 2012), Risk Evaluation and Mitigation Strategies for drug safety (February 2013), and hospital outsourcing of high-risk compounded drugs (April 2013)
- DOJ press release: resolution with Amgen, Inc. settlement. December 19, 2012
- DOJ press release: resolution with TranS1, INC. July 3, 2013
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