“Truthful and non-misleading” are the new buzzwords inside the Beltway for pharmaceutical and medical device marketers. They’re replacing “unapproved uses” and “off-label” in the FDA’s regulatory lexicon — but you won’t hear the agency actually say so. Not yet.
That change is coming about in the wake of a string of First Amendment-based losses for the FDA in federal courts around the country, and the FDA’s pragmatic decision not to appeal those defeats.
As interpreted by Washington Legal Foundation chief counsel Richard Samp at an American University seminar in March, this means that the FDA has “pretty much given up” calling all drug company dissemination of peer-reviewed literature about unapproved and off-label uses “misbranding” the products.
And by giving up on that, the FDA is tacitly signaling that so long as promotional activity remains both truthful and non-misleading — truthful speech can still be misleading — the FDA won’t worry if it hasn’t approved the use in question.
That’s a huge step, even if the FDA hasn’t publicly announced it yet.
One reason for the delay is that it needs to coalesce with other interested agencies on the change, such as the Federal Trade Commission, which regulates nonprescription drug and most medical device advertising.
Both the FDA and FTC have traditionally defined “truthful” as meaning the claim is backed up by two adequate and well-controlled clinical studies, according to Samp.
The linkage with “non-misleading” is critical, Public Citizen Litigation Group’s Allison Zieve said at the same seminar.
And in a recent email, the FDA’s Office of Prescription Drug Promotion director Thomas Abrams stated: “It is just using our resources among our multi-component program to best achieve our public health mission of having truthful, non-misleading, and balanced promotion.”
James G. Dickinson is editor of Dickinson’s FDA Webview.