The U.S. Food and Drug Administration (FDA) released a memorandum in late December laying out guidelines for the use of social media, such as Facebook and Twitter, by pharmaceutical companies in marketing their products. The memo’s release came more than two years after the FDA held hearings on the matter in November 2009. Although the memo provides useful guidance, it is not nearly as comprehensive as industry insiders expected. The guidelines only deal with online discussions of off-label drug uses, those which lack explicit FDA approval.
Social media, the FDA felt, poses different challenges and risks than previous technological advances in marketing, such as television advertising, because social media allows much faster access to information and more direct contact between manufacturers and consumers. It convened hearings in November 2009 to examine these concerns. According to the New England Journal of Medicine, the FDA issued warnings to fourteen drug companies in April 2009 after it found sponsored ads for prescription drugs in search engines that lacked a clear statement of risks.
A major question for the FDA was that of “balance,” making sure consumers had access to all relevant information about a particular drug. This includes not only information about known side effects, but also, when claims are made about a drug, about the financial interests of the person or company making the claim. Among social media services, it is also increasingly difficult to determine whether a pharmaceutical company is responsible for a claim about a medication. Google and sites like Wikipedia make it increasingly easy for the general public to make claims about prescription drugs. The FDA has a responsibility to police the accuracy of claims made by the manufacturers. A major challenge for the FDA is therefore how to deal with inaccurate information widely disseminated by people other than the manufacturers.
The FDA’s guidelines address unsolicited requests from consumers for information about “off-label” uses. Generally, companies should not directly answer questions posted online about off-label uses, but should refer people to their websites or hotlines for more information. Answering such questions, the FDA says, is not unlawful per se, but could count as “evidence of a new intended use.”
Major pharmaceutical companies, or “Big Pharma,” spent $1 billion on online marketing in 2011, according to Ad Age. This number is expected to keep increasing, but it still represents a small percentage of pharmaceutical marketing. The industry expected clear, definitive guidelines on social media use, but got something more vague. The FDA has stated that, because of the ever-evolving nature of social media, it will not issue platform-specific guidelines for each social media service. It says it plans to issue further guidelines in the future.
The lack of definitive rules puts the burden, in many respects, on the “judgment” of the manufacturers themselves and their marketing departments. Put another way, it puts a burden on consumers to verify the information they receive online. People who have used the internet for a while probably knew this. Now the FDA has added its voice, saying it can help, but only so far.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen are skilled at assessing liability and damages for injuries caused by medication errors and helping their clients obtain compensation. For a free consultation to review your case, contact us today online or at (800) 654-1949.
Web Resources:
Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF), U.S. Food and Drug Administration, December 2011
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Patient Safety Initiatives in Maryland and Oregon are Showing Signs of Success, Pharmacy Error Injury Lawyer, October 26, 2011