- The Washington Times - Monday, January 23, 2006

It’s important to place the Food and Drug Administration’s new rule on physician labeling (which provides for more prescriber-friendly information about pharmaceutical products) into the appropriate context: urgent.

The American health-care system is undermined, underserved and undervalued when labeling is written more for corporate-liability protection than as a valuable tool for health-care providers — as it is today but not for long.

The public’s access to timely, innovative and affordable health care is severely impaired when manufacturers respond to liability costs by withdrawing beneficial products from the marketplace. An example of this is Bendectin (pyroxidine HCl/doxylamine succinate), a drug approved by the FDA in 1956 to prevent nausea during pregnancy.

Although the FDA and the scientific community determined that the drug did not cause birth defects, isolated statements to the contrary in the scientific literature beginning in 1969 prompted a flood of lawsuits. By 1983, the costs of these suits were so great that the manufacturer withdrew the product from the market. More liability results in less availability.

Health-care innovation is thwarted when manufacturers choose to devote their finite research and development resources to creating products they believe will not be associated with uncertain and potentially high-stakes liability costs.

Today, developers of new medical products increasingly need to set aside billions of dollars, or redirect their research activities from potentially valuable directions, in anticipation of the potentially unlimited risk of mass tort lawsuits. The lack of innovation in the areas of vaccines, contraceptive products and “orphan drugs,” or drugs for serious and life-threatening diseases that affect small segments of the population — extensively documented by the federal government and others — only begins to illustrate the point that more liability results in less innovation.

Today, labeling includes excessive risk information and exaggerated warnings. This has set into motion a dangerous dynamic: labeling that does not accurately communicate to either the health-care professional or the patient the conditions in which any given product can be used safely and effectively. This is nothing less than a grave menace to the public health.

The FDA’s most potent weapon in the battle for accurate, timely, “rational” prescribing is clear, approved labeling. The FDA’s legal and legislative authority over labeling for prescription drugs and biological products is complete, according to federal statute, in almost every respect.

The Food, Drug and Cosmetic Act clearly gives the FDA the authority to decide whether or not a product, when used properly, is safe, effective and properly labeled. As former FDA chief counsel (and my former colleague) Dan Troy said, “You want the FDA to have the last word if you believe in the FDA’s expertise.” I, for one, believe that a product, used as described in FDA-approved labeling, should be considered safe and effective throughout the United States. And a majority of Americans are of the same opinion. According to the most recent AP poll on the matter, more than three-quarters of Americans have confidence in the FDA.

Consider this, comprehensive studies by the Rand Corp. and others demonstrate that only a small fraction of lawsuits that result in settlement payments or jury verdicts actually involve low-quality care. Rather, the hallmark of big awards is bad outcomes.

Unjustly, only a small fraction of patients who are injured negligently get compensation. And when they do, most of it goes to lawyers and the very high costs of administering this inefficient, unfair, broken system. The system needs to change so that it will deter bad care, not reward bad lawyers. When public health is put before private gain, tort law and the lawyers who practice it play a very important role in protecting and enhancing America’s health.

The dedicated members of our legal profession have always provided, and continue to provide, vital protection against those who would prey on consumers or intentionally try to pass off harmful products. The threat of litigation can be an important disincentive to many predatory behaviors.

The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications. More and more often, these “mass tort” firms specialize in taking a new product-warning label or withdrawal decision by the FDA and viewing it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health-care system.

The FDA has the authority, the ability, the means, the mission and the mandate to manage the health-care risks and benefits inherent in the products it regulates on behalf of the American public.

Peter J. Pitts is a former associate commissioner of the FDA and a senior fellow at the Pacific Research Institute.

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