To no one’s surprise, on December 23rd the Government filed a motion to dismiss Par Pharmaceutical’s complaint challenging the Constitutionality of the FDA’s regulations that effectively ban all off-label (and some on-label) promotion. As we discussed in our last post, the Par suit represents the latest and perhaps the most unique First Amendment challenge to the FDA’s off-label rules. However, if you were hoping to learn more about the Government’s theory on why its one-sided view on off-label promotion should be upheld, you’ll be disappointed. Instead of filing a public memorandum, with a supporting affidavit or two, explaining why the Government has a substantial interest in ensuring that drugs can only be marketed for uses that the FDA has determined is ‘safe and effective’, and why the FDA’s regulations are substantially tailored to further that interest, the Government found it “necessary . . . to file its memorandum, statement of material facts and the Declaration of Dr. [Rachel E.] Sherman under seal on Decmeber 23, 2011.” See Unopposed Motion to File Documents Under Seal . According to the Government’s three-page motion, the Sherman Declaration and Government Memorandum contain confidential information that the FDA received (quite possibly from Par) that the Government is precluded from disclosing. The Government does state in its motion, however, that it will promptly consult with Par’s attorneys and may thereafter file either a redacted version of its motion to dismiss or for summary judgment, or even an entirely unredacted version with Par’s consent.
Since Par is the party seeking to strike down the FDA’s regulations on free speech grounds, let’s hope they uncensor the Government and allow it to unseal its motion (without redactions) for all of us to see and contemplate.
In what appears (to this former federal prosecutor) as a timely and perhaps not too coincidental measure to head off the criticism (raised in Par, Caronia , and elsewhere) that the Government’s off-label rules offer little guidance to drug and medical device companies on what they can and can’t say about their products’ off-label uses, the FDA issued draft guidance on December 27th that would allow manufacturers to speak about off-label uses, but only in response to an unsolicited request for off-label information. See Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. The FDA’s draft Guidance appears not only to formally recognize the established (albeit previously unwritten) “safe harbor” of responding to private off-label questions from health care practitioners, but also addresses the question of responding to public off-label questions driven by millions of consumers who have turned to the internet for health care information and advice. Although the Guidance is still in draft form and not binding, it offers 7 specific recommendations for responding to private off-label questions (e.g., remind the requestor that the FDA has not approved the off-label use; limit the response to the scope of the initial question; document the question and the response given) and 4 specific recommendations for responding to public requests for off-label information (e.g., responses should be confined to the manufacturer’s own product and not a competitor’s product; responses should direct the requestor to contact the manufacturer’s medical or scientific staff). However, even if the request is truly unsolicted, the manufacturer’s response must not be “promotional in nature or tone.” Who decides whether a manufacturer strikes the right “tone”? You guessed it: the FDA.
While we need to commend the Government for offering some important, overdue guidance in this area, none of the recommendations in the draft Guidance deals with the central thrust of the Caronia and Par challenges: that the FDA’s rules (including the Guidance) violate a manufacturer’s right to provide, and the medical community’s right to receive, truthful, non-misleading, accurate and balanced information about its product’s medical uses, even if one or more of those uses haven’t been formally approved by the FDA. Although tactically sound, the Government’s latest arrow misses the mark.