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These Statements Have Not Been Approved by the FDA: Improving the Post-Approval Regulation of Prescription Drugs

The American public’s confidence in the FDA is waning in the midst of increased reporting of inefficiencies in the agency. The missteps by the FDA in the post-approval regulation of prescription drugs are magnified by the pervasive use of prescription drugs in the market. This article identifies these missteps. It also chronicles the response of the state attorneys general to this void in regulation, from the famous class action suit against the tobacco industry to the Oxycontin litigation to the recent Vioxx settlement. This response to the public’s lack of confidence is accomplished through lawsuits against pharmaceutical companies under state consumer protection laws. In protecting their citizens, the state attorneys general have begun to institute new regulations in the prescription drug industry, outside of the FDA's purview, through the use of innovative settlement terms, with the tobacco industry settlements serving as a template. The state attorneys general have also used these settlement agreements to take a more active role in filling the void created by an inefficient FDA in enforcing federal laws. In fact, terms of recent settlements even contractually require certain companies to self-report violations of federal law to the state attorneys general. The states can bring the companies that have violated settlements before a judge in a contempt proceeding and seek injunctive relief and monetary damages. The threat of these actions and the likely public relations disaster arising from such proceedings may very well serve as significant incentives for the pharmaceutical companies to follow the law and the terms of the settlement agreements. But there are many difficulties that arise from a system in which two different enforcers (both state and federal) are monitoring and enforcing a pharmaceutical company’s compliance with federal law. Not the least of these problems is the likely overlap of penalties and inconsistent interpretations of the federal regulations by the two bodies. To overcome these difficulties, the FDA should reorganize itself and push Congress for greater enforcement capabilities. The agency should vest the responsibility for monitoring and regulating prescription drugs after their approval to the Office of Surveillance and Epidemiology. To ensure the Office of Surveillance and Epidemiology can restore public trust in post-approval regulation of prescription drugs, Congress should enact legislation that allows this new division to effectively regulate the industry through the use of civil fines and criminal prosecution against companies that refuse to follow its orders.