Comments to FDA draft guidance are normally tame affairs, but not when they come from the Washington Legal Foundation (WLF), which boasts about its history of successfully suing the FDA. WLF's May 15 comment on a revised February 2014 draft guidance about distributing medical publications about off-label uses of devices and drugs is a case in point.
WLF says the guidance has "chilled" the dissemination of information and violates the First Amendment, to which it makes no references. "That omission is particularly glaring when one considers that, in the five years since release of the 2009 guidance, both the U.S. Supreme Court and the U.S. Court of Appeals for the Second Circuit have issued important decisions that strengthened the First Amendment rights of drug and device manufacturers to speak truthfully about off-label uses of their products," WLF says.
More specifically,WLF argues that the draft guidance violates the terms of a 1999 injunction prohibiting the limitation of peer-reviewed journal articles that it won against the agency in the case WLF v. Friedman.
According to Alexander Gaffney of the Regulatory Affairs Professional Society, the draft guidance says the articles distributed should not have been funded by the company, be unabridged, contain information from an "adequate and well-controlled clinical investigation" and be "scientifically sound." WLF says those conditions go too far, arguing that "in the absence of such revisions [removing the conditions], it will be virtually impossible for manufacturers to distribute reprints in a manner that complies with the draft guidance."
WLF says that the FDA has avoided litigation by declining to enforce the draft guidance, and says many companies do not follow its recommendations. Still, WLF warns that it "intends to enforce its injunction and will seek contempt of court citations against FDA officials who violate its terms."
The comment and draft guidance are the latest incarnations of the ongoing debate about the appropriate promotion of off-label uses of drugs and devices. The FDA's original 2009 draft guidance on this sticky issue was shot down by industry, leading to the recent revised draft, offering further proof of the stickiness of this issue.
Even Congress weighed in on the issue of off-label promotion via journal articles in the passage of the 1997 Food and Drug Administration Modernization Act. But the provision expired in 2006, opening up a legal gray area pitting FDA's draft guidance against the First Amendment, or at least that's how WLF views it.
- read the WLF comment
- read RAP's article on the comment
- read the revised draft guidance