Management Issue 7: Oversight of Food, Drug, and Medical Device SafetyTopics on this page:
Through the work of FDA, the Department is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, medical devices, the Nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for protecting the rights, safety, and well-being of human subjects who participate in trials conducted for the products it regulates. Through the work of NIH, the Department is responsible for acquiring knowledge that can help prevent, diagnose, and treat disease and disability. Given these critical public health mandates, NIH and FDA must have in place policies and programs that ensure the integrity of medical research endeavors, protect human research subjects, provide for preapproval and postapproval monitoring of regulated medical products and treatments, and ensure the safety of the nation’s food supply. Oversight System for Protecting Human Research Subjects Over the past decade, numerous OIG evaluations and audits have consistently documented weaknesses in the Department’s oversight system for protecting human research subjects in clinical trials associated with NIH grants and those conducted by manufacturers seeking FDA approval for regulated products. In 2007, OIG examined FDA’s oversight of clinical trials through its Bioresearch Monitoring (BiMo) program. This work identified vulnerabilities, such as data limitations, that inhibit FDA’s ability to effectively manage the BiMo program. OIG also found that FDA inspected only one percent of clinical trial sites during the FY 2000-2005 period. OIG recommended that FDA improve its information systems and processes, establish a mechanism to provide feedback to BiMo investigators on inspection findings, and seek legal authority to provide oversight that reflects current clinical trial practices. Looking forward, OIG will follow up on its previous work on protections for human research subjects and oversight of clinical trials. For example, in FY 2008, OIG will evaluate the review process for the Office of Human Research Protection (OHRP), which is charged with oversight of all research involving human subjects that is conducted or funded by the Department. OIG will also evaluate the use of data safety monitoring boards for clinical trials sponsored by NIH. Monitoring Drugs Approved for Marketing Recent OIG work has also identified weaknesses in FDA’s monitoring of drugs following their approval for marketing. In 2006, OIG examined FDA’s monitoring of drug sponsors’ postmarketing study commitments and the timeliness with which these studies are completed. This work identified several vulnerabilities that limit FDA’s ability to readily identify whether or how timely these commitments are progressing toward completion. As a result, OIG recommended that FDA instruct drug applicants to provide additional, meaningful information in their annual status reports about postmarketing studies. OIG also recommended that FDA improve its management system for monitoring postmarketing study commitments and ensure that these commitments are being monitored. In the months following the OIG report, the Institute of Medicine issued a report that highlighted FDA’s resource limitations and lack of regulatory authority to enforce required postmarketing studies. The challenge of monitoring a drug’s safety after its initial approval has also been highlighted in media accounts and congressional inquiries. For example, Congress recently held hearings on an approved diabetes drug, Avandia, that was associated with an elevated risk of heart attacks. In FY 2008, OIG will expand its review of FDA’s postmarketing efforts to evaluate adverse events reports for medical devices. OIG has recently conducted other evaluations of FDA’s preapproval and postapproval oversight of drugs. In 2006, OIG completed a review of FDA’s National Drug Code (NDC) Directory, which is intended to be a complete and accurate listing of currently marketed prescription drug products. OIG found that the NDC Directory is neither complete nor accurate and recommended that FDA improve guidance for industry and streamline the NDC submission and verification processes. Further, because of concerns about a generic drug review backlog, OIG is currently evaluating FDA’s review process for generic drugs. Food Safety Since the terrorist attacks of 2001, and emphasized by the recent cases of microbial pathogens found in spinach, tomatoes, and peanut butter and a toxic chemical found in pet food, the security of the Nation’s food supply has also been a great concern for the Department, as well as for public health and homeland security experts. OIG is assessing whether food can be traced through the distribution chain and whether food facilities are complying with the new requirements. In FY 2008, OIG also plans to review FDA’s food safety operations related to its oversight of imported food products. As part of this study, OIG will review FDA’s food facility inspection process, FDA’s oversight of imported food, and FDA’s procedures and activities related to 2007 recall of tainted pet food. Protecting Human Research Subjects HHS has implemented many changes to protect human research subjects and to strengthen FDA and NIH oversight of scientific research. Within the Office of the Secretary, OHRP coordinates closely with both NIH and FDA in carrying out its responsibility to ensure human subject protections. In June of 2006, FDA announced a Human Subject Protection/Bioresearch Monitoring (HSP/BIMO) initiative and formed a HSP/BIMO permanent council that is responsible for central coordination and human subject protection. FDA also published a proposed rule in July 2004 for the creation of an institutional review board registry. Additionally, in 2006 and 2007, FDA released several draft guidances that addressed various bioresearch-monitoring topics. Finally, in response to OIG’s recent report on the oversight of clinical trials, FDA indicated that it is developing an internal listing of all ongoing clinical trials as part of a broader effort to electronically manage FDA’s regulated product information. Monitoring Drugs FDA has also contracted with Booz Allen Hamilton to assess the decisionmaking, tracking, and review process behind requests for postmarketing study commitments (PMCs) for human drugs and biologics to develop recommendations for improving the quality of the PMC processes. The pending reauthorization of the Prescription Drug and User Fee Act could provide FDA with increased resources for improving its postmarketing safety surveillance. Congress is also considering giving FDA additional authority to require postmarketing studies. Food Safety Recent events have demonstrated the critical need to protect the Nation’s food supply and have drawn specific attention to the safety and security of imported food. FDA is now implementing provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which requires, among other things, all parties within the food distribution chain to establish and maintain records that identify sources and recipients of food products, allows for the detention of food under certain circumstances, requires food facility registration, and requires that the FDA receive prior notice of food imported into the United States. In 2007, FDA announced the creation of a new position, Assistant Commissioner for Food Protection.
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