As the Food and Drug Administration moves to finalize its new rule on physician labeling designed to provide more prescriber-friendly information about pharmaceutical products, it's important to place this action into the appropriate context: urgent.

America deserves access to high-quality health care without avoidable medical errors and complications. This achievable goal begins with harnessing and using the power of information. And that begins with clear, accurate, and usable labeling.

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.

Today, labeling includes excessive risk information and exaggerated warnings. And 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.

America is suffering from a legal system that is dangerous to its health. Why has this happened? There is, unfortunately, a simple answer - fear of liability.

Manufacturers have significant monetary incentives to add dense and confusing legalese because, under current law in most states, they can be found liable for failing to provide "adequate" warnings about therapeutic products.

Money, not medicine, is driving this dangerous practice. When it comes to labeling written for lawyers rather than doctors, more is less.

Less Availability
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. The signal example of this is Bendectin (pyroxidine HCl/doxylamine succinate), a drug approved by FDA in 1956 to prevent nausea during pregnancy.

Although the Food and Drug Administration and the scientific community have 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.

Less Innovation
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.

Liability risk is inversely related to levels of research and development activity. 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.

More Cost
Higher health-care costs inevitably occur when manufacturers adjust to the out of control tort environment by pricing certain products they perceive as presenting particular liability concerns at a significant premium over others.

Higher prices create pressures to reduce the use of approved products, contrary to the objective of rational prescribing.

More than ever before, rising costs threaten to price the benefits of modern technology out of the range of many of the patients who most need it. And these cost pressures are going to increase as our population continues to age and more treatment options become available.

According to many experts, the differential cost of health care between America and Canada can be explained by product-liability considerations. Higher prices create pressures to reduce the use of valuable, safe, and effective health care options. More cost results in less effective health care.

More Fear
Doctors are, literally, being sued out of their medical practices. Insurance rates are forcing many hospitals and clinics to shutter emergency rooms and trauma centers and cancel other vital services such as obstetrics.

Doctors are moving to specialty areas with lower premiums, moving to states with fairer legal systems, or retiring from the field altogether. Patients are suffering from a legal system that is dangerous to their health.

Consider what's happening in Mississippi. More than a few towns in the state have lost significant access to needed medical care - especially in the Delta, where the economic conditions are such that they need help the most.

Physicians who specialize in family medicine and obstetrics/gynecology in Indianola and in other rural areas of the state have stopped delivering babies and have even moved away because of skyrocketing insurance costs caused by out of control liability. These dedicated health-care professionals are very worried and so are their patients.

Because of rising insurance costs, only one doctor with expertise in head trauma was available last July to cover all the hospitals in Gulfport, Mississippi. One patient reportedly suffered permanent brain damage as a result. More fear results in less care.

Less Fairness
Comprehensive studies by the Rand Corporation and others demonstrate that only a small fraction of lawsuits that result in settlement payments or jury verdicts actually involve low-quality care by physicians. Rather, the hallmark of big awards is bad outcomes, not bad care.

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 the tort system threatened the development of lifesaving medical products in the past, we found creative solutions. Consider the disaster that faced childhood vaccines in the mid-1980s.

Under the weight of litigation, prices for vaccines increased tenfold, and the number of manufacturers dropped to only four from about 20 - and only two in America. So Congress took most child-vaccine litigation out of the tort system and created the well-respected Vaccine Compensation Fund.

Today, it's widely understood that vaccines are safer than ever, not despite these fundamental litigation reforms but because of them.

Allies Rather than Adversaries
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.

Tort law, appropriately applied, helps patients get redress for truly negligent care. When product manufacturers provide fraudulent information to the FDA, or deliberately withhold information about safety problems associated with their products, they should be held accountable.

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.

One woman, speaking to a reporter for the Jackson Clarion-Ledger, summed it up this way: When she read that the drug Propulsid might cause harm, she stopped taking it and signed up for a lawsuit.

"Actually, I didn't get hurt by Propulsid," she told the newspaper. But because she had taken the drug, she said she thought she could join a class-action lawsuit "and I might get a couple of thousand dollars."

Less fairness results in more damages.

Labeling as the Solution, Not the Problem
Labeling can and must be a valuable tool for improving and protecting America's health. That's the law. Rational prescribing occurs when a health care professional orders an approved prescription drug or biological product in circumstances where the risk/benefit profile of the product is optimal.

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 Federal Food, Drug, and Cosmetic Act establishes mandatory and prohibited labeling content and manufacturers have no choice but to comply with these requirements.

Less obvious, but equally important, is the principle that the Act also constitutes a "ceiling." In other words, a manufacturer cannot add risk information to labeling unless the FDA has specifically granted its permission.

The FD&C Act clearly gives the FDA the authority to decide whether or not a product, when used properly, is safe, effective, and properly labeled.

A product, used as described in FDA-approved labeling, should be considered safe and effective throughout the United States.

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.

Maybe when our elected officials understand that it's the health of their constituents versus the pocketbooks of lawyers, our public servants will finally get serious on tort reform.