Truth or Consequences

The Benefits of Off-Label Drug and Device Promotion

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Over the past half-century, the U.S. Food and Drug Administration (FDA) has made it increasingly harder for Americans to get access to innovative new drugs and medical devices. By raising the hurdles medical products manufacturers must clear before they get approval, the agency has increased the cost of new treatments and delayed their availability.

Fortunately, physicians and patients often have access to drugs and devices that can treat certain illnesses, but which have been approved by the FDA for other uses. This practice, called “off-label” prescribing, provides greater choice in treatment options for millions of Americans, but the FDA and many congressional critics have tried to stymie its use for decades. At Congress’s urging, the FDA has long forbidden drug and device makers from disseminating information about off-label uses, which makes it difficult for doctors and their patients to learn about important therapeutic options. This may change, however, if a pending lawsuit against the FDA is successful.

In October 2009, the California-based drug manufacturer Allergan filed a lawsuit against the FDA seeking a declaratory judgment that distributing truthful and relevant information about the safe and effective off-label use of drugs and devices violates no federal statute and that the agency’s regulatory ban on off-label promotion is an unconstitutional restriction of free speech. A hearing on procedural motions is scheduled for April 26, 2010, though it could be years before the case is finally resolved. Nevertheless, an eventual victory for Allergan would also be a victory for the millions of American patients who rely on off-label uses.