Many people assume that oversight of drug development and marketing by FDA is adequate to insure public protection from dangerous products, and that an FDA-approved product’s benefits outweigh its risks. Professional evaluations of FDA capabilities have unfortunately proven those assumptions wrong time and again. The agency’s handling of Risperdal is a perfect example of the systemic problems in the drug approval and safety surveillance processes.
FDA Fails with Risperdal: Problems Timeline
A 2003 report from the Office of the Inspector General, Department of Health and Human Services – of which FDA is a part – concluded that the FDA review process for prescription drugs faced significant challenges that undermined the process’ effectiveness, particularly in drug labeling review, post-market surveillance, dissemination of information to the public that form the basis for its decisions (OIG, 2003). The report also concluded these problems with the NDA review process needed to be addressed in order to ensure protection of public health (OIG, 2003).
In 2006, the Institute of Medicine (IOM) published a report entitled “The Future of Drug Safety: Promoting and Protecting Health of the Public” (IOM, 2006). The report concluded “the drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.”
In 2007, the Subcommittee on Science and Technology published a report titled, “FDA Science and Mission at Risk” (Subcommittee on Science and Technology, 2007). That report concluded FDA has serious deficiencies that could affect its ability to meet its regulatory responsibilities. Specifically, the report stated that scientific demands on the agency far exceed its capacity to respond, and further, that this imbalance places FDA at risk in terms of the integrity of the regulatory system and the ability to protect public health.
A 2009 report by the General Accounting Office found that the FDA lacks resources to adequately protect public health, particularly in the area of monitoring post-market safety. This report also found weaknesses in FDA monitoring and enforcement that impede its ability to effectively oversee phase IV post-marketing studies (GAO, 2009).
Pattern of FDA Limitations
A pattern has emerged that shows the FDA sadly limited in its ability to ensure protection of public health. Nevertheless, the public, as well as physicians who prescribe drugs to their patients, have continued to depend on the compromised agency. It has also become clear that what a given drug maker knows about its drugs may not be knowledge shared with FDA. It is the drug maker’s duty to accurately inform physicians and their patients of timely and complete safety information throughout the life of a drug, but time and again it has been shown that this is not the way the system works.
FDA does No Clinical Testing
Many assume FDA actively conducts clinical trials for drugs. The FDA, however, does no clinical testing itself. FDA, physicians and their patients must rely on drug makers to properly design and conduct clinical trials that are used by FDA for NDA approval decisions. FDA, physicians and their patients rely on drug makers to provide full and adequate reporting and disclose all clinical data and analyses. The problem comes when drug makers do not honestly assess or share their drugs’ problems with the people who are faced with prescribing and using those drugs. This is exactly what plaintiffs accuse Johnson & Johnson and Janssen of doing with Risperdal, of exaggerating Risperdal benefits while hiding its problems. The companies have already paid several billions in criminal and civil penalties for their marketing and promotion of Risperdal, and they lost the first civil action trial over the drug. Several more Risperdal trials are scheduled for jury trials in the next few years.