New drugs cannot be sold or promoted in the United States until they have passed FDA-approved tests for safety and efficacy in a specified use, called the on-label use. But physicians are free to prescribe a drug not only for its on-label use, but also for other off-label uses. Off-label prescribing is a vital aspect of modern medicine because it often happens that new and important uses are discovered for old drugs. Physicians learn of off-label uses from extensive medical research reported in peer-reviewed publications, newsletters, lecture presentations, conferences, advertising and trusted colleagues. Pharmaceutical companies are an especially important source of information.
Its disturbing, therefore, that pharmaceutical companies have come under attack for promoting and researching off-label uses. An activist group, for example, is suing Pharmacia Corp. for promoting a drug for an off-label use. Pharmacia manufactures a drug called Bextra, which is FDA approved (on-label) for certain cases of chronic pain. The suit alleges that Pharmacia promotes the use of Bextra for acute pain, a use for which Bextra is not FDA certified and hence is off-label. For the most part, the FDA forbids the promotion of off-label uses. According to Ahaviah Glaser, director of the group sponsoring the suit, Pharmacias promotion puts consumers at risk.
So, what is the devious deed? Pharmacia funded clinical testing of Bextra in relieving acute pain from impacted molars, and the results were published in The Journal of the American Dental Association. One would think that funding new research should be encouraged, not prohibited. New research advances scientific knowledge, medical treatment, and human well-being. For that Pharmacia is the object of litigation and recriminations.
The controversy comes from the fact that the research outfit Pharmacia hired is partly owned by Omnicon, a large advertising conglomerate. That research findings come from such openly promotional entities should raise eyebrows, but such information is not hidden. Why shouldnt promotionally oriented research compete freely in the intellectual marketplace? Questions about the integrity and seriousness of the research ought to be sorted out by the peer-review process of scientific journals. Advertising claims are policed by agencies like the Federal Trade Commission, and pharmaceutical consumers. Prohibiting pharmaceutical companies from funding or promoting research on off-label uses throws the baby out with the bathwater. Advertising and research sometimes save lives.
We now know that aspirin can prevent heart attacks and ameliorate the effects of a heart attack once it has begun. But for many years the FDA prevented aspirin manufacturers from advertising the results of clinical studies supporting this knowledge. The FDA finally sanctioned aspirin for heart-attack patients years after the clinical studies had been completed. Dr. Carl Pepine, codirector of cardiovascular medicine at the University of Florida College of Medicine, estimated that as many as ten thousand lives annually could be saved by getting the word out. In other words, Dr. Pepine thought that the FDA restrictions preventing the advertising and promotion of aspirin for heart attack patients were responsible for the deaths of tens of thousands of people.
The deleterious consequences of off-label speech restrictions run even deeper. Imagine a drug company investigating a new chemical compound and deciding whether to develop a drug for approval and sale. Because it will not be allowed to promote off-label uses, expected profits will be less. Maybe the company does not bother to search for and verify any off-label uses. Health suffers. Maybe the diminishment of expected profit in the off-label market keeps the company from developing the drug at all. Because the FDA restricts speech in the off-label market, prospective beneficiaries in the on-label market lose out.
The rationale for the restrictions says that if drug companies were allowed to promote uses that are not FDA certified, they would make unproven and sometimes false and misleading claims, with flashy ads and dubious endorsements to sway the public.
Because the vast majority of drugs in question are prescription-only, that rationale must also maintain that doctors are easily led to favor inferior therapies over superior therapies. But doctors concerns for market reputation, professional esteem, avoidance of lawsuits, and basic human morality all push in the healthy direction. Drug companies must preserve their reputation and guard against lawsuits and prosecution for misleading advertising. Shady promotional tactics tend to be exposed by public officials, consumer groups, professional groups, and competitors. Thus, besides being conceptually weak, the rationale for prohibiting the promotion of off-label uses for FDA approved drugs is devoid of empirical support.
Economists John Calfee and Paul Rubin have shown how the FDAs efforts to protect consumers from misleading information have prevented consumer awareness of healthful opportunities. Calfee concludes: "The evidence is very strong that the FDA suppresses a great deal of useful information."
The group sponsoring the Bextra suit, the Prescription Access Litigation Project, claims to be interested in reducing drug prices. Yet Rubin maintains that if the FDA freed up commercial speech, "the results will be greatly improved health of consumers and reduced prices of pharmaceuticals."
When someone can sue a pharmaceutical company for funding medical research, it is time for a serious and candid reconsideration of the law.
JUDGE AND JURY: American Tort Law on Trial
The fear of litigation reduces innovation, drive physicians and manufacturers out of lawsuit-prone specialties, and increase manufacturing and consumer costs. In the courts, data from thousands of cases all over the country demonstrate that tort system awards are driven by political factors such as judicial elections, jury compositions, and the location of courts themselves.