Besieged Drug Makers Seek FDA Guidance on “Off-Label” Speech

Seven large drug companies last week threw up their hands in exasperation and implored the Food and Drug Administration (FDA) to provide them with some meaningful guidance regarding their speech rights.  They filed a formal Citizen Petition, asking the agency to spell out what they are permitted to say regarding off-label uses of their products.  The Petition noted that FDA has, to date, provided virtually no meaningful guidance, and none is expected any time soon.

Perhaps the most surprising aspect of the Petition is its conciliatory tone.  The seven companies might have noted that numerous court decisions – including one issued by the Supreme Court on June 27 – have indicated that the First Amendment places significant restraints on the government’s authority to limit truthful speech by drug companies.  Or that FDA is subject to a permanent injunction issued in litigation initiated by Washington Legal Foundation, which limits FDA authority in certain contexts to prevent manufacturers from speaking truthfully about off-label uses of their products.  Or that virtually all medical experts agree that widespread dissemination of truthful off-label information is an essential component of effective health care delivery.  But the Petition says nothing that might be deemed critical of FDA; it simply asks FDA to tell drug companies what the law is, so that they can adjust their policies accordingly.  The companies noted that they risk criminal and civil sanctions if they guess wrong regarding the dividing line between permissible and impermissible manufacturer speech.

Among the areas for which the Citizen Petition requests guidance: (1) manufacturer responses to unsolicited requests for information; (2) “scientific exchange” designed to advance medicine rather than to promote a product; (3) interactions that manufacturers may have with formulary committees, payors, and similar entities; and (4) dissemination of third-party clinical practice guidelines.  The manufacturers noted that they are frequently called upon to discuss medically-recognized off-label uses of their products in each of those four contexts, but that FDA has never explained how much off-label speech it will tolerate in those areas before concluding that a manufacturer is engaged in improper promotion of an unapproved new use.

No one should be surprised by FDA’s unwillingness to date to provide guidance regarding the limits of permissible manufacturer speech on off-label use (that is, prescribing an FDA-approved. drug or device for a use for which it has not received FDA approval).  While FDA encourages everyone other than manufacturers to speak freely about off-label uses, it has long discouraged any such speech by manufacturers on the theory that manufacturer speech is inherently biased.  But on several occasions on which FDA has issued policies that prohibited truthful speech by manufacturers or distributors, courts have struck down those policies on First Amendment grounds.  So in order to avoid future litigation, FDA has preferred to act in an ad hoc manner, initiating criminal proceedings against companies that it deems to have gone “too far,” without issuing clear guidance regarding how far is “too far.”  By acting in an ad hoc manner, FDA has managed to avoid most First Amendment challenges to its policies.

Let’s hope this latest Citizen Petition will help FDA realize the tremendous uncertainty being created by its unwillingness to provide detailed guidance regarding what can be said.  Joining in on the petition are seven of the nation’s largest drug and device companies: Allergan, Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer, and Sanofi-Aventis.

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