Rarely does one person influence how the US Food and Drug Administration (FDA) looks at a company, but every so often one person comes along and-for better or worse-changes the agency's perspective. This article is about the latter of those two possibilities.
An example of the former may well be Dinesh Thakur, who blew the whistle on deficient practices at Ranbaxy, practices for which the company has now paid hundreds of millions of dollars.
But if that's evidence of one person acting in good faith, a recent notice from the US Department of Justice (DOJ) shows that one person can cause just as much harm.
The 29 May 2013 statement from DOJ relates to Luke Truesdell, an Iowa man sentenced to five years in prison for making a false statement on Facebook. As with other interactions between FDA and social media, Truesdell ran afoul of federal law and regulation not because of the medium, but the message-a message that is decidedly not for the squeamish.
False Statements on Facebook
Per the DOJ's synopsis of the case, Truesdell was once employed by a food manufacturer regulated by FDA, but in January 2012 was fired from that job. Shortly thereafter, he reportedly called FDA, saying that he was infected with hepatitis B and had, during the course of his employment, bled into batches of the regulated consumer product manufactured by his former employer. Truesdell would later post similar information on the Facebook "wall" of one of his employer's customers, DOJ continued.
The problem: None of that appeared to be true at all, and was simply made up to harm the reputation of the former employer, DOJ said.
"This case demonstrates the blatant misuse of social media to intentionally cause financial harm to business entities manufacturing FDA regulated products," said Special Agent in Charge Patrick Holland of FDA's Office of Criminal Investigations, Kansas City Field Office, in a statement. "The FDA will continue to aggressively pursue perpetrators of such acts, and ensure that they are punished to the full extent of the law."
Neither FDA nor DOJ have indicated who that employer might be, saying only that it manufactured a "consumer product," likely a food product or dietary supplement, and that the employer would be paid nearly $18,000 in damages for Truesdell's false statements.
FDA/DOJ Press Release