Theodoros and Rooth, P.C.

Off-Label Promotion of Drugs Can be Dangerous

The Food and Drug Administration (FDA) gives official approval to a pharmaceutical product based on convincing scientific evidence proving it has benefits. Drug marketing is also strictly regulated so companies do not make biased or misleading claims. Doctors may use a drug for off-label purposes (conditions for which the product is not approved by the FDA) if practical experience has shown that this use is effective. But should pharmaceutical sales representatives be allowed to tell doctors about off-label uses for their drug products?

Until a recent U.S. Circuit Court of Appeals judgment, doing so was illegal. Doctors could share off-label information, but not manufacturers. Arguments that this restriction was a violation of the Constitutional freedom of speech prevailed, however, and drug companies can now promote both on- and off-label uses. It remains to be seen whether the case is appealed to the Supreme Court.

The American Medical Association supports the decision, but others are concerned that the ruling allows pharmaceutical companies to circumvent FDA regulations and mislead physicians about off-label protocols. In fact, this has already occurred with other drugs, including Rapamune.

Two former employees sued Wyeth, and the subsequent parent company Pfizer, for making false claims about off-label uses of Rapamune. It was approved as a kidney transplant drug, but Wyeth sales reps persuaded transplant centers to use it off-label for other kinds of organ transplants, even though the FDA had warned against this. The suit claims that by withholding clinical information, Wyeth caused harm to transplant patients who suffered serious side effects and fatalities as a result of taking the off-label drug. It also alleges that the company targeted African-American transplant patients, even though there was no clinical data to justify such a decision.

If you are the victim of an off-label drug, you need the help of an experienced defective products attorney.