FDA And Social Media - The Safety And Innovation Act Gives FDA Two More Years To Explain The Rules On How Industry May Use The Internet And Social Media

As Congress resets the clock until after the elections, the Supreme Court issues significant opinions limiting governmental power to restrict commercial speech. On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act giving the FDA two years to "issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products..." The FDA has been studying this issue since 1996. It has held numerous hearings, issued notices and guidance, and pursued countless enforcement actions based on on-line content. Nonetheless, despite over 16 years of deliberations, the rules remain unclear. In FDA's defense, technology is a moving target and new media continues to evolve and revolutionize how society behaves and shares information. However, the lack of clear guidance has significantly silenced the one voice with the most reliable scientific information concerning medical products - the manufacturer. While it is not clear what guidance FDA will ultimately issue, it is clear that Congress has reset the clock for FDA to provide "guidance" until after the 2012 elections.

Despite Vague Rules, Civil Penalties and Criminal Prosecutions Set New Records

On July 2, 2012, the Department of Justice announced its landmark $3 billion dollar settlement of civil and criminal charges with GlaxoSmithKline concerning, among other things, its promotion of products for uses not approved by the FDA. Vague rules create an unfair playing field where regulatory agencies "interpret the rules as they see fit" and the risk to industry in defending protracted civil and criminal litigation includes exclusion from government programs, additional criminal prosecutions and, possibly, debarment (i.e. corporate death penalty of exclusion from marketing products).

The Supreme Court is Increasingly Critical of Vague Regulations that Limit Speech

Meanwhile, over in the Supreme Court and barely audible in the din of recent Court rulings on immigration and healthcare, the Supreme Court issued decisions in two significant cases involving vague regulations applied to limit commercial speech. In FCC vs. Fox, a case concerning broadcast content, the Supreme Court stated "[w]hen speech is involved, rigorous adherence to [due process] is necessary to ensure ambiguity [in the rules] does not chill protected speech." The Court went on to state that, "[a] statute which...