What Is Off-Label Promotion?
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?
Is Off-Label Promotion Legal?
While the FDA has strict rules about what can be officially promoted by pharmaceutical companies regarding their products, they are less strict about what can be “communicated” to healthcare providers about the off-label uses of certain medications.
This is due in part to the FDA’s inability to monitor every avenue of communication and promotion, as well as the some disagreement on where regulations run up against freedom of speech laws in the United States (you can read more about this here).
Examples of Harmful Off-Label Promotion
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 prescription or promotion, you need the help of an experienced defective products attorney. Call our medical malpractice lawyers at Theodoros & Rooth today to get started.