With Par Pharmaceutical Suit, Courts Should Put an End to FDA’s Lawless Behavior on Off-Label Speech

Cross-posted by Forbes.com on WLF Contributor Site

The Food and Drug Administration has been largely successful in avoiding judicial review of claims that its regulation of drug promotion activities runs afoul of First Amendment constraints.  But FDA may well be unable to avoid a merits-based review of First Amendment claims raised in a lawsuit recently filed by Par Pharmaceutical, Inc.  Par complains that FDA is chilling its speech rights by threatening to crack down on truthful speech about on-label uses for its FDA-approved products.

Although FDA has long suppressed even truthful manufacturer speech about FDA-approved drugs, the dearth of challenges to such restrictions is understandable.  For one thing, most drug manufacturers are quite reluctant to file lawsuits against an agency which reviews new drug applications.  Moreover, FDA generally issues “guidance” documents (rather than more formal regulations) to announce to its new policies, and courts have been hesitant to entertain challenges to such documents because they arguably do not represent binding agency policy.  In response to past First Amendment challenges, FDA invariably has argued that the lawsuits are not “ripe” for judicial review because they do not arise in the context of specific speech but rather are mere “hypothetical” disputes about the plaintiffs’ anticipated speech.

FDA’s “ripeness” defense should fail in the Par litigation.  One of Par’s principal products is Megace7, a hormone that stimulates appetite.  FDA has approved its use to treat weight loss in patients with AIDS.  Although FDA has not approved the distribution of Megace for the treatment of such “wasting” within other, non-AIDS patient populations, doctors widely prescribe Megace for those off-label uses as it is viewed to be one of the most effective treatments for wasting in geriatric and cancer patients.  According to Par, FDA claims that even truthful promotional speech about Megace’s on-label uses is illegal, if directed to doctors which Par knows are highly likely to prescribe Megace for off-label uses.  Par contends that FDA’s policy has chilled its speech rights by causing it to cut back on its truthful on-label speech – because it justifiably fears criminal prosecution.  Given the allegations of a present-day chilling effect, the U.S. District Court for the District of Columbia (which is hearing Par’s lawsuit) is likely to conclude that the suit is ripe for review because it presents a sufficiently concrete dispute between the parties.  The court recently ordered both sides to file dispositive briefs; the briefing schedule runs through March 2012.

Moreover, Par has a good chance to prevail on the merits of its First Amendment claims.  FDA regulations provide that a manufacturer can be deemed to harbor an “objective intent” to market one of its products for an off-label use if it knows that the product is likely to be put to an off-label use by those to whom it sells the product.  Federal law provides that a drug is “misbranded” (and thus subject to seizure) unless it provides “adequate information” about each of its intended uses – including any intended off-label uses.  And, of course, a manufacturer is not permitted to include labeling information for any off-label uses.  Thus, if FDA concludes that a manufacturer intends to market a product for an off-label use, FDA deems the product misbranded and subject to seizure.

In past instances in which FDA has concluded that a manufacturer intends to market a product for off-label use, it has done so on the basis of statements by the manufacturer that directly discussed off-label uses.  But in Par’s case, FDA is focusing on on-label communications.  Par’s sales representatives have been reaching out to doctors at long-term care facilities to discuss Megace’s use in treating AIDS-related wasting.  FDA apparently takes the position that when the doctors work at facilities where the great majority of patients suffering from wasting are not AIDS patients, one can infer that Par’s actual intent in approaching such doctors is to promote Megace for off-label uses – regardless what the sales representatives actually say.  Indeed, federal prosecutors have begun an investigation of Par’s efforts to promote use of Megace at long-term care facilities.

By taking that position, FDA is risking a major First Amendment loss.  The Supreme Court has taken a dim view of government efforts to suppress truthful commercial speech, and its recent IMS Health decision signals an increased commitment to giving heightened First Amendment scrutiny to any such suppression efforts.  FDA will have a difficult time justifying a policy that seeks to prevent dissemination of truthful information about on-label uses of Megace, particularly in light of the absence of any substantial government interest that could be advanced by such suppression.  FDA can’t very well argue that it has a strong interest in preventing doctors from prescribing Megace for off-label use, given that: (1) FDA has no authority to regulate the practice of medicine; (2) Megace is viewed by medical authorities as one of the most effective treatments for wasting in geriatric and cancer patients; and (3) federal medical programs regularly reimburse the costs of such treatments.

FDA undoubtedly will argue that Par’s lawsuit is not yet ripe for review.  But given Par’s assertion that prosecutors’ on-going criminal investigation has caused the company to cut back on its speech to doctors, it is difficult to understand how the case could become more ripe than it already is.

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