Wednesday, August 04, 2004

Legal Deference Is Bad Medicine

FDA legal deference is bad medicine

Janssen Pharmaceutica Products never hid damaging results, they “minimized potentially fatal safety risks and made misleading claims about the drug,” according to a recent report in the New York Times. The product in question, Risperdal, is given to more than 10 million people worldwide. It was not until a doctor asserted that children could be hurt or killed by these drugs that the FDA obtained this admission by the company.

First there was the lawsuit. Then the drug company came clean about the side effects.

Zoloft – prescribed for depression – can produce suicidal thoughts in children, but this incredible oversight was not revealed when the FDA approved the drug. These are not isolated cases, according a 2002 study in the Journal of American Medical Association. There have been seven drug recalls after reports of death and severe health complications in the last 10 years. The complete list food and drug recalls and alerts, month by exhaustive month, may be found at

This constant stream does not reflect poorly on the FDA, which can only make decisions based on the quality of information they receive. The drug applications come from companies with a vested interest in convincing the FDA to approve. Corners often get cut, and the data get selected to optimize chances of acceptance. Hence, the recalls.

At present, the current Administration is arguing in court that FDA decisions should be immune to legal challenge. The argument basically states that, if the FDA approved it, you cannot sue the drug maker for any ill effects it causes you. This curious deference to a governmental agency gives the FDA an ultimate say so, over which the individual has no recourse.

The Administration, however, argues that preventing litigation in these cases is good medicine. Freeing multi-billion dollar companies from the threat of lawsuits, it is contended, will provide a permissive environment for them. Otherwise, they might be too timid to develop a potentially lifesaving drug.

Even a quick glance at the FDA list of new drug trials argues against this possibility. To date, hundreds of new drug trials have been applied for, despite the present legal environment.

The irony is that the new authority given to the FDA does not benefit them in anyway. They make decisions based on data received in applications, and would never know if a drug company picked the best 1% of the data to submit, and neglected to reveal the rest. It is a common error to assume that the FDA performs the research themselves. It does not, but only evaluates the “best case” proposals it receives from pharmaceutical companies who desperately want their drugs approved.

Legally asserting that the FDA’s decisions are final gives unprecedented protection for the drug companies. Once any drug is accepted by the agency, the company would be completely immune to liability.

In the meantime, anyone who suffered from an undisclosed side effect of a drug would have nowhere to turn. The law would shield the company, there’s no one to vote out of office, and no one to contact (does anyone know the Board of Directors for Pfizer? Would you write them a letter?). Basic rights in this case would be forfeit.

Although this position is being actively pursued by the Administration, it’s unclear that it would ever pass Constitutional muster. In fact, Duke University law scholar Erwin Chemerinsky remarked that “The Supreme Court has expressly ruled that FDA regulations do not preempt state law and local regulation.”

We cannot speculate on the motivations of the Administration in becoming the champion for this Constitutionally questionable legal stance that empowers corporations at the expense of consumers. But we can say that it would produce a situation in which individuals would lose their most basic protections.

Will Clower, Ph.D.

Will Clower is a Pittsburgh-based health writer and founder of The PATH. He can be reached by email:

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