The St. Louis Post Dispatch editorial got it right this morning when it argued that the legalization of off-label marketing would prove to be dangerous for consumers. The newspaper’s editorial concerned Allergan’s lawsuit against the FDA for disallowing off-label marketing practices as a violation of free speech. As a point of clarification, doctors may prescribe any medicine for purposes they deem appropriate. However, drug companies are not allowed to market their drugs for those purposes not specifically approved by the FDA. This seems like a common sense, obvious consumer protection that should continue.
The Post Dispatch writes persuasively: “Rightly or wrongly, doctors rely on pharmaceutical company marketing as an important source of information about drugs.
Letting drug companies stack the deck by providing truthful but incomplete information about off-label uses increases the odds that doctors will write prescriptions for those uses. The case in point: Cox II inhibitors.
The drugs were approved to treat arthritis pain without causing stomach or intestinal problems. Studies conducted a decade ago found that most users of those medicines weren’t at risk for those problems.
You might think it wouldn’t matter. The evidence shows otherwise. Two of the most popular Cox II inhibitors, Vioxx and Bextra, later were taken off the market after testing showed that they increased the risk of fatal heart problems and strokes.”