May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles and medical texts that contain off-label information, the Washington Legal Foundation (WLF) stated that as written, the draft guidance violates a 1999 federal court injunction that prohibits the agency from preventing manufacturers from disseminating peer-reviewed reprints that contain truthful off-label information.

Further, the draft guidance, which revises a 2009 draft guidance on the topic, “raises serious First Amendment concerns regarding manufacturers’ rights to speak truthfully about important health care issues,” according to WLF Chief Counsel Richard Samp. (View the comment: FDAComments-RevisedReprintsGuidance)

“By attempting to restrict truthful speech, FDA is endangering public health,” Samp said. “Just the specter of the agency taking an enforcement action against a company has a chilling effect on speech,” he told the Coalition for Healthcare Communication.

“The WLF’s comment reminds the agency that it must transform its policies and practices to align with the First Amendment,” said Coalition for Healthcare Communication Executive Director John Kamp. “Manufacturers should be able to distribute truthful information – in the form of journal articles, medical textbooks and practice guidelines.”

WLF states that the agency could be in contempt of court if it violates the 1999 federal court permanent injunction (WLF v. Friedman) by attempting to enforce speech restrictions outlined in the draft guidance, which would limit distribution to materials that report on adequate and well-controlled clinical investigations, “a standard that would virtually eliminate dissemination.”

In the comment, WLF noted that it pointed out numerous problems in the 2009 guidance that this draft guidance seeks to revise and “is dismayed that the Draft Guidance makes no effort to correct any of these infirmities; indeed, the Draft Guidance omits any reference to the First Amendment.” The comment goes on to say that this omission is “glaring” because of important court decisions rendered by the U.S. Supreme Court and the U.S. Court of Appeals for the Second Circuit in First Amendment cases.

The FDA’s apparent unwillingness to yield on this issue may stem from some “wiggle room” in the law, according to Samp. “The courts have always said the First Amendment protects free speech, but on the other hand, the government is entitled to regulate commercial conduct,” he explained to the Coalition. “So the FDA’s position is that it is not punishing companies for their speech, but using their speech as evidence of conduct they are intending to do.”

However, the comment states that the First Amendment “does not tolerate the Draft Guidance’s efforts to prevent such dissemination altogether, except when the materials are so deficient that they could not possibly meet minimal scientific standards – in which event they would not be appearing in a medical textbook or peer-reviewed journal in the first place.”

Samp noted that the growing body of First Amendment case law in the FDA arena does serve to constrain the agency “to a certain extent,” in that companies that raise First Amendment issues in off-label use settlements with the government often can reduce settlement amounts. Further, the agency does not appear to be going out of its way to enforce its position where distribution of reprints – and not sales force dissemination of other uses not included in reprints – is the sole activity in which a company engages.

However, the current state of affairs leaves industry at risk. “Companies have gone to the FDA saying they need clear rules, and that there is no way that they can distribute reprints and comply with the current policy,” Samp added. To allow the dissemination of truthful, constitutionally protected speech and not violate the injunction or the First Amendment, WLF asks the FDA to:

(1)    Eliminate any reference to “adequate and well-controlled clinical investigation,” a reference that will be interpreted as imposing severe limitations on the types of journal articles that may be disseminated;

(2)    Narrow the overly burdensome “disclaimer” requirements, such as that the article be accompanied by a comprehensive bibliography and articles/texts expressing contrary or different conclusions; and

(3)    Scale back on the limitations imposed on disseminating medical texts, particularly the distribution of individual chapters from a medical text.

“In the absence of such revisions, it will be virtually impossible for manufacturers to distribute reprints in a manner that complies with the Draft Guidance,” WLF states. The comment also asserts that WLF “intends to enforce its injunction and will seek contempt of court violations against FDA officials who violate its terms.”

“Without changes to the current scenario, valuable information about the off-label use of approved therapies will be shared less and less,” the Coalition’s Kamp said. “And that will limit both innovation and treatment options for patients.”