In its ongoing efforts to address the “rapid growth of the Internet, including social media tools and other emerging technologies,” and its use by medical professionals, consumers and drug and medical device manufacturers and distributors, the Food and Drug Administration (FDA) recently issued a draft guidance proposing ways that a drug or device company may choose to respond to unsolicited requests for information regarding use of a drug or device for an “off-label” purpose without running afoul of FDA regulations.1

The Issue

Before marketing a product, a drug or medical device company must demonstrate, through various processes, that the product is safe and effective when used for specific purposes and with labels and warnings that have been approved by the FDA.2 After FDA approval, however, a doctor, other medical provider, or even sometimes a patient may determine that the product may be safely and effectively used for a purpose that was not approved by the FDA—that is, an “off-label use.” Still, manufacturers and distributors are forbidden to “promote” the off-label use, no matter how well-accepted by the medical community the alternative may become.