For more than fifteen years, the U.S. Food and Drug Administration has struggled to craft a policy on how the Internet may be used to promote medical products.
Now, the FDA has a firm deadline: July 9, 2014.
On Monday, President Obama signed into law a bill that will require the FDA to finally state its policy on use of the Internet – including social media – to promote medical products that are regulated by the FDA.
Under Section 1121 of the bill, the FDA has two years from the date the bill was signed into law to issue the new guidelines.
The provision is one of several “Miscellaneous Provisions” in a bill that reauthorizes the FDA to collect user fees from drug companies and creates new user fee programs for generic drug manufacturers.
The FDA has been deliberating on the subject of online drug promotion since as early as 1996, when it held public hearings on Internet advertising and promotion. But the FDA failed to issue any guidelines and subsequently halted all such work, according to a 2010 report from Corporate Compliance Insights.
In 1999, the FDA announced that it would “look at [Internet-related] issues on a case-by-case basis,” according to the report. Its continued failure to state a policy, though, has created uncertainty in the pharmaceutical industry.
In November 2009, the FDA held hearings to get public input on the topic of promotion of FDA-regulated medical products using the Internet and social media tools. (Transcripts of those hearings are available here.) Still, the FDA has not issued a formal policy.
The new law requires the agency to finally do so, and the clock is ticking.