Management Issue 12:
Oversight of the Approval, Safety, and Marketing of Drugs and Devices
Why This Is a Challenge
The Department, through FDA, is responsible for ensuring that all drugs, biologics, and medical devices are safe and effective. The Department must also ensure that once a drug, biologic, or device has been approved for use, it is marketed appropriately. However, OIG work has revealed weaknesses in FDA's ability to adequately oversee the safety of drugs, biologics, and medical devices. In particular, we have found vulnerabilities in FDA's ability to ensure the timeliness of drug application reviews; the adequate monitoring of adverse-event reporting for medical devices; and the prevention of off-label marketing of drugs, biologics, and medical devices. In addition, as a result of expanded authorities under the ACA to approve biosimilars (generic biologics), FDA will need to develop a plan to implement these new authorities without exacerbating its backlog for drug approvals. Ensuring that participants in clinical trials are protected from significant risk presents an additional challenge to the Department both during the initial approval process and after drugs, devices, and biologics are approved by FDA when post-marketing trials are conducted.
Progress in Addressing the Challenge
FDA has taken actions to address some of the vulnerabilities related to timely review of generic drug applications, including issuing a final rule and providing guidance on what to include in generic drug applications. FDA also developed a new database to more effectively review and follow up on adverse-event reports for medical devices.
FDA has an ongoing Human Subject Protection/Bioresearch Monitoring Initiative tasked with modernizing the regulation of clinical trials across the spectrum of a product's lifecycle. FDA also has a Good Clinical Practice (GCP) Initiative with the European Medicines Agency underway that will permit the use of limited resources through joint inspections. The goal of this effort is to establish a mechanism for sharing information regarding applications and inspections while providing FDA with an enhanced understanding of health systems, medical practice, and regulatory requirements in foreign countries.
OIG is also working with law enforcement partners to investigate and prosecute drug and device manufacturers that engage in illegal marketing or conduct unauthorized clinical trials. For example, in November 2010, Synthes, Incorporated (Synthes), and its subsidiary, Norian Corporation, pleaded guilty to conducting clinical trials of a medical device without FDA authorization. Both companies agreed to pay the maximum criminal monetary penalties. They had conducted unauthorized clinical trials of Synthes's medical devices in surgeries to treat vertebral compression fractures of the spine, despite an FDA-cleared label warning against this use for this device and in the face of serious medical concerns about the safety of the devices when used in the spine. In another case, Novartis Pharmaceutical Corporation agreed to pay $422.5 million and enter into a corporate integrity agreement with OIG to resolve civil liability resulting from Novartis' violations of the Anti-Kickback statute and criminal and civil liability resulting from Novartis' marketing and promotion practices for Trileptal, an epilepsy medication, for a variety of conditions that were not approved by FDA.
What Needs To Be Done
The Department needs to focus on reducing off-label promotion, which may put patients in harm's way and may increase fraudulent claims for payment by federal health care programs. OIG is increasingly using its administrative authorities to sanction individuals and entities that engage in fraud and abuse in the pharmaceutical and medical device industries.
Key OIG Resources
- FDA's Generic Drug Review Process (OEI-04-07-00280)
- Adverse Event Reporting for Medical Devices (OEI-01-08-00110)
- FDA's Oversight of Clinical Trials (OEI-01-06-00160)
Management Issue 13: Oversight and Enforcement of the Department's Ethics Programs
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