After waiting over two years, the pharmaceutical industry finally has a set of guidelines from the Food and Drug Administration (FDA) about using social media to market their products, although they might not be quite what the industry expected. Rather than a set of comprehensive guidelines, the FDA issued a 15-page document limited to the issue of online requests for information on “off-label” uses of medications. “Off-label” typically refers to uses other than those specifically approved by the FDA. This is far less than what much of the industry, known to many as Big Pharma, expected.
The FDA has regulated marketing and advertising of certain controlled substances since its founding in the early 20th century. In recent years, the technology of marketing and advertising has changed at an ever-increasing rate. The amount that Big Pharma spends marketing its products directly to consumers reportedly went from $579 million in 1996 to over $4 billion in 2008. Social media has played a role in marketing and advertising of pharmaceuticals for years, but the FDA did not specifically address the question of how existing rules apply to social media until recently. Big Pharma reportedly spent $1 billion on social media marketing in 2010, and that number is expected to keep increasing.
In April 2009, the FDA took one of its first major actions in regard to social media, sending warning letters to fourteen drug companies who were allegedly sponsoring search-engine ads for certain pharmaceuticals without including legally-required statements of risks. Drug companies had used what they called the “one-click rule,” meaning that information on risk was no more than one mouse click away from any web page containing marketing information. Social media, which allows consumers to post their own information, makes it very difficult to maintain risk information in proximity to drug information.
The FDA held public hearings for two days in November 2009 to discuss social media marketing of pharmaceuticals. It considered how pharmaceutical companies may present information through their own websites, but also how they might support third parties, such as bloggers or Twitter users, who could post information outside of the FDA’s normal area of review by offering positive reviews of products or challenging negative information. At the time of the hearings, observers thought the FDA might choose to ban social media marketing of prescription medications entirely, according to the New England Journal of Medicine. The FDA’s eventual response, issued in December 2011, is not nearly as far-reaching as many expected and some feared.
The guidelines issued by the FDA, which they say is the first in a series of guidelines, addresses unsolicited requests for off-label use information, meaning requests for information posted by consumers on industry websites or social media pages. Companies should have a website or 800 number available where they can refer consumers with off-label questions. Companies are free, generally speaking to answer questions online about FDA-approved uses. Posting information online about off-label uses, the FDA warns, could be construed as evidence of a new intended use, which could lead to a new FDA review.
People who have suffered injury due to a medication error in a pharmacy or hospital may be entitled to compensation for their damages. For a free and confidential consultation with an experienced Kansas City pharmacy error lawyer, contact Doug Horn at Horn Law today through our website or at (816) 795-7500.
Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF), U.S. Food and Drug Administration