Misbranding is a crime under federal law, specifically the Food Drug and Cosmetic Act. By definition under that law, a drug is misbranded if its labeling is "false or misleading in any particular." When a drug is prescribed by a physician, it is essential that the information to make an informed decision about the benefits and the risks of using that drug on a particular patient be accurate. The benefit risk analysis is the reason for the existence of the misbranding statute. The Food and Drug Administration has ignored this statute and pretended it doesn't exist for big pharmaceutical companies for years and years. When a small unconnected upstart company appears on the horizon, particularly when it threatens market share of one of the major players, the FDA will step in on occasion and enforce the various provisions of the misbranding statute mercilessly.
There are three confluent issues which trigger my need to discuss the misbranding statute. The first goes back to 1995 when the Republican dominated legislature of Michigan granted virtual absolute immunity to the drug industry. The essence of that law shielded the industry from liability so long as FDA approval was given for the marketing of the drug. That immunity from liability has been extended by the pseudo-conservative Supreme Court of Michigan to include off-label uses of drugs for which no testing had been approved. The second issue is that this same protection may be extended nationally by the federal courts as several cases seek such protection work their way through the judicial process. The so-called self-designated non-activist judges who claim not to make legislative decisions or new law stand ready to reward the drug industry for the generous support of the Republican party lo these many years. The final issue which triggers me is the recent revelation that the Bush administration has "negotiated" with major corporate players during the last three years to avoid criminal prosecution of these companies on charges ranging from bribery to fraud. Instead, it has been entering into so-called deferred prosecution and nonprosecution agreements, in which companies are allowed to pay fines and hire monitors to watch over them. Advocates of this approach say these deals save the government time and the expense of going to trial and avoid doing unnecessary harm to corporations and their employees.
The cost to the public and the rule of law is too high for this to continue. People get hurt and die from ill-considered use of prescription drugs. Drug sales for popular drugs reach billions of dollars annually. Based on my 35 years of experience in critically examining the conduct of drug companies, the major wrongdoing falls into the category of minimizing known harmful effects of any given drug. That experience has also taught me that the FDA is a bumbling industry-oriented, ass kissing organization where decisions are made by employees of the FDA who are waiting to turn their Agency experience into an advancement opportunity within the pharmaceutical industry. To eliminate jury consideration of the wrongdoing of drug companies does not serve the public's interest in having safe drugs with appropriate information available. The basic question must be asked; is it not part of conservative thought that one must be held responsible for the consequences of one's conduct? The real reason behind this multi-pronged effort to shield the drug industry from being held accountable for its behavior is the false premise that 'might makes right.'