Prescription Drug “Off-Label” Marketing: Free Speech or Negligent Action?

By January 14, 2013Product Liability

While pharmaceutical products have unquestionably saved lives and improved the quality of life for millions of people, they still can and do pose dangers. That’s why the Food and Drug Administration, founded in 1906, regulates all prescription and over-the-counter drugs in this country.

A recent court decision, however, may limit the FDA’s powers to safeguard the nation’s consumers from the dangers of prescription medicines.

As part of its regulatory responsibilities, the FDA approves new drugs for specific uses and treatments, which then are outlined on the drug’s label. (With respect to pharmaceutical marketing, “labels” encompass not only what’s on the bottle but multi-page literature that comes with the bottle, brochures, and advertising.) Pharmaceutical companies and their representatives are barred from marketing drugs to consumers and physicians for any use other than for what they’ve been approved.

When a drug company makes claims that a drug can treat conditions or diseases for which it is not approved – call “off-label” marketing – it runs afoul of FDA regulations and federal law.

That’s what happened when a New York pharmaceutical rep was convicted in federal court for marketing the drug Xyrem for unapproved uses to a physician. He appealed his conviction, saying the FDA’s regulations denied his First Amendment right to free speech. In December of last year, the U.S. Court of Appeals for the Second Circuit agreed, and overturned his conviction.

The Court’s ruling applies only to New York, Connecticut and Vermont. But if the decision is brought before the U.S. Supreme Court and is confirmed, the consequences for consumers may be much more wide-reaching.

Consumers who have been harmed by known but unadvertised side effects or the unapproved use of prescription drugs have the legal right to seek compensation, particularly through class-action litigation. Anyone who suspects they or their loved ones have been so victimized may want to seek out an attorney experienced in such matters.