FDA Enters the Digital Age by Issuing 22 Warning Letters to Web Site Operators
The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.
During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.
The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.
Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell....hopefully sooner, rather than later!
Until next time...
Good Luck and Good Surfing!!!!!!!!!
Mark Senak, who writes the outstanding 
As we all know, the H1NI pandemic has been raging on for close too 10 ten days now. Curiously, “Fear & The Flu: The New Age of Pandemics” is the title this week’s cover story in Newsweek magazine. From an informational standpoint point, “this may be too little, too late”—as the old saying goes. While the Internet has been around for over twenty years now, government agencies, most notably the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to rely almost exclusively on old media to communicate with the American public during infectious disease outbreaks. Apparently, the administrators who run these government agencies haven’t been listening closely enough to President Obama’s assertion that “we live in the digital age.”
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