“The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.” (New York Times 7/25/04). This is an interesting and theoretically justifiable principle. It is founded on the belief that if the Food and Drug Administration (FDA) has sanctioned a product that has met governmental safety standards, to allow lawsuits would mean that federal safety standards are set (Bush administration quote) “insufficiently high and this belief would undermine public health.”

This thought-provoking concept could be extended in many directions. Such a principle would mean that determinations of harm would be taken from lay panels of jurors and judges. This is something I favor. I also favor removing malpractice from the tort system and making it an arbitration process through a specialized commission system in which independent experts, with the help of lay panelists, would independently review cases. This would allow more suits to be filed and more cases to be reviewed, with, hopefully, more appropriate fines, also removing 1/3 of the fee that goes to the lawyer. However, that’s a separate, albeit related, issue. This principle could also be extended to protect tobacco companies from lawsuits once nicotine is regulated by the FDA. It could expand into health related fields to mean that once the government has declared a site as not-toxic then citizens could not sue for damages. In short, the government knows best and once it has taken a position it cannot be challenged.

There are certain tenets that we must agree on before we can assume that drugs and devices are safe simply because the FDA says so. How can we assume that the FDA is fair, honest, and diligent? We have increasing data to show that the FDA has become politicized. Abortefacients recently became the first type of drug where the FDA overruled its own expert panel. With that obvious political statement, how can we be certain that future judgments won’t be tainted by industry ties, or political connections? The FDA has in the past few years allowed advertising of prescription drugs, for the first time empowering patients to choose their medications. This creates a market force that is difficult to resist and clearly represents a tilt towards industry.

It is not uncommon for a drug to be approved by the FDA and then discovered to cause an adverse effect not found in the pre-approval testing process. Effects that occur only once in a thousand cases say, will not be found until tens of thousands of people use the drug. I would argue that a company should not have responsibility for these uncommon side effects so long as it has scrupulously kept up its post-marketing surveillance and reported every adverse event to the FDA in a timely manner. The companies must be trustworthy. This requires full disclosure. During the spring and summer of 2004, drug companies have been successfully sued for failing to publish data or even submit them to the FDA when drugs have proven to be ineffective. Sometimes these negative studies have occurred in studies of disorders close to the approved indications. Specifically, I’m referring to antidepressants which work in adults but possibly not in children. If no drug is approved for childhood depression (or some other disorder) but is approved for the adult condition, then it makes sense for doctors to use the adult preparation in children, especially when no drug has been approved for this problem. This is done all the time, and for some drugs the “off label” uses outstrip the approved indication. But when a study finds no efficacy and the result is then buried, while doctors, with the knowledge of the companies, continue using the drug for this indication, because they don’t know it doesn’t work, then a moral line has been crossed. Equally disturbing is the fact that these lawsuits were instituted by New York State and not the federal government. The FDA did not seem to manifest any interest in the problem, perhaps a sign of bureaucratic inertia, lack of funding to do an adequate job, or political ideology (or worse).

The heart of the matter, as I see it, is responsibility. Allowing companies to hide behind an FDA approval fairly begs companies, many of which have been successfully sued in the past year for malfeasance of various types, to be less thorough and less safe. Why would we trust a company that hides data showing their drug to be useless while continuing to suggest the opposite? How can it be trusted to collect and publish data that reveals adverse effects unless it is required to, and that this requirement carries stringent penalties in case of default; and that the monitoring agency is reliable and honorable?

I do not see why pharmaceutical companies should be treated differently than car manufacturers. If the drug or device is found to cause harm once it’s approved, that problem must be monitored and reported to the FDA (as is currently the case). When this effort is not diligent the company should be sanctioned by the FDA. When the FDA fails to do the job properly it seems that the only recourse a consumer would have is a lawsuit. To deny this possibility will not only reduce the public safety but undermine our confidence in the FDA approval process, the very principle the federal government states it is trying to strengthen.