The FDA recently warned AMARC Enterprises, Inc., a California-based dietary supplement company, that its Facebook page (https://www.facebook.com/poly.mva) was not in compliance with FDA guidelines. Poly MVA, the AMARC brand name used on Facebook, inappropriately “liked” a consumer testimonial, the FDA’s December, 2012 warning letter noted. The consumer post read, in part, “Poly MVA … enabled me to keep cancer at bay without the use of chemo and radiation.” The agency further criticized a May, 2010 Facebook posting that offered information on how supplement ingredients, “… can nutritionally support the body during cancer and cancer therapy.” Criticism of Poly MVA’s use of social media comes at the end of a long list of other FDA violations, all revolving around failure to comply with various aspects of the Federal Food, Drug, and Cosmetic Act (FDCA). [Read more...]
Government Takes A “Pass” on the First Amendment
Last week it was reported across the internet that the FDA would not seek to appeal the Second Circuit’s majority decision in U.S. v. Caronia to the Supreme Court. Admitedly, in the wake of Caronia, I and other commentators were hopeful that the Government would seek a rehearing en banc — the Government even asked for an extension on the deadline to file the petition — and ultimately oral argument before the Supreme Court on the limits of its ability to regulate manufacturer speech. However, that collective hope waned once the Government passed on an en banc rehearing. Indeed, it soon became obvious that the ”best” course for the Government would be to avoid the risk of further adverse rulings, renew its campaign against weak-kneed manufacturers in off-label investigations outside the boundaries of the Second Circuit and focus its Supreme Court lawyering in other high-stakes areas, like “reverse payments” in patent Hatch-Waxman settlements. If the Government follows through on its reported January 22nd “statement” – no official statement was ever published to this writer’s knowledge – and fails to appeal Caronia to the Supreme Court by the March 4, 2013 deadline, the answer to the question ”what now?” becomes dicey for manufacturers. [Read more...]
A First Amendment Safe Harbor for Off-Label Promotion — The Right Course for the Government
It has been a busy month for legal commentators digesting the Second Circuit’s “landmark” decision in U.S. v. Caronia and its ramifications for the pharmaceutical industry. By ruling 2-1 that truthful, accurate and non-misleading off-label speech is constitutionally protected that cannot be used by the Government as the sole basis upon which to prosecute drug misbranding under 21 U.S.C. Section 331(a), the majority panel sent shock waves through the legal writing community. While there has been no shortage of articles, alerts and commentary on the subject, few have addressed the only two important questions that remain in the aftermath of Court’s decision: First, will the opinion stand? Second, if it does, can manufacturers actually begin to promote off-label? [Read more...]
Caronia Decided — First Amendment Protects Off-Label Speech!
It finally happened. After two long years (plus one day) since oral argument, the U.S. Court of Appeals for the Second Circuit in a 2-1 split vote decided U.S. v. Caronia, tossing Alfred Caronia’s misdemeanor conviction for engaging in off-label promotion. The former Orphan/Jazz Pharmaceuticals sales rep had argued that in promoting Orphan’s Xyrem for unapproved uses, he did not speak untruthfully, inaccurately or in a misleading manner and that his conviction under 21 U.S.C. Sections 331(a) and (a)(1), therefore, violated his right of free speech under the First Amendment. Fortunately for Caronia — and perhaps even more fortunately for pharmaceutical and medical device manufacturers, battered by billions in fines – two federal circuit judges agreed. Unfortunately, the fight is probably far from over. [Read more...]
Generic Skinny Labeling – A Different Kind of Off-Label Promotion – Part I
Let me start by apologizing for the long hiatus since my last posting in July. While the demands of law firm practice often interfere with a legal blogger’s desire to publish on a frequent and consistent basis, work commitments this past Summer were particularly unforgiving for this blogger. When I finally sat at my keyboard, I double-checked to make sure there had been no major events in the cases that I have been following for this blog, particularly the Caronia and Par cases. Regretably, we are quickly reaching the second anniversary of oral argument before the Second Circuit in Caronia and we still don’t have a decision. In the Par case, negotiations between the Government and Par Pharmaceuticals are continuing into their ninth month and I am still predicting a settlement with no discussion of Par’s First Amendment challenge. So, before moving away from the topic of off-label promotion entirely, and keeping with this blog’s commitment to deal with other “risks” facing the pharma/med device/bio-tech industries, I’d like to discuss a topic that is mostly of interest to patent lawyers, but which is instructive on the Government’s thinking on what really is and isn’t “off-label” use: generic “skinny labeling” of innovator drugs. [Read more...]
Government Gets Big Win Against Abbott; On Verge of Silencing First Amendment Challenge
Although we are only one month into May, it has been a tough month for the pharmaceutical industry and those of us who are still looking to see if either the Second Circuit in U.S. v Caronia or the D.C. District Court in Par Pharmaceutical v. U.S. et al., will shed any light on whether manuafacturers have a First Amendment right to discuss a product’s unapproved uses with healthcare professionals. [Read more...]
The Morality of Off-Label Promotion
I thought long and hard about the title for this post and admit that I wanted it to be eye catching, as well as accurate for the subject matter being discussed. So why discuss the morality of off-label promotion? Well, despite hundreds (if not thousands) of legal briefs, articles, speeches, power point presentations, conference materials, etc., debating the legality, propriety and constitutionality of off-label promotion, not much has been said about the morality or ethics of a manufacturer’s decision to market, promote or encourage the off-label use of its products. The Government has strenously argued that any manufacturer off-label promotion, if permitted, would usher in a kind of “pre-1962″ era of unsafe and ineffective drug and medical device use. However, the better argument is that truthful and non-misleading off-label promotion should not only be allowed on free speech grounds, but when aimed at established, medically accepted uses, should be encouraged as both appropriate and ethical. [Read more...]
Par Stays on the Offensive
When I last posted on the subject of Par Pharmaceutical’s lawsuit challenging the FDA’s off-label rules on free speech grounds, the Government had filed a motion to dismiss the suit and for summary judgment on several grounds, including Par’s lack of “standing” and the “unripeness” of its claims. The Government ginned up its legal attack with a lengthy and emotional appeal, buttressed by the Declaration of the FDA’s Dr. Rachel Sherman, that unless the FDA’s off-label regulatory scheme was upheld, public health and safety would be jeopardized. In a clever counter-move, Par filed a motion for limited discovery, arguing that the Government’s interjected three material facts that now require Dr. Sherman’s deposition and other discovery. [Read more...]
The Government Unseals Its Counter-Attack Against Par
To no one’s surprise, last week the Government filed a Notice unsealing its Brief, Statement of Material Facts and the Declaration of Dr. Rachel E. Sherman (with exhibits) in support of its Motion to Dismiss (or for Summary Judgment against) Par Pharmaceutical’s Complaint challenging the constitutionality of the FDA’s off-label regulations and rules. Although the Government’s papers are quite lengthy, its attempt to defeat Par’s free speech challenge is based on both legal argument and fear.
Before launching an essentially two-pronged legal attack, including challenging Par’s standing to bring its suit in the first place, the Government spends considerable time reciting the drug approval process and the history of the Food Drug and Cosmetic Act (FDCA), particularly the “Kefauver-Harris” Amendments of 1962, which required that drugs be effective (as well as safe) for any indicated use prior to marketing. Both in its brief and, especially, in Dr. Sherman’s Declaration, the Government recounts for the reader a parade of historic horribles, where drugs with widespread and generally accepted off-label uses were found (after rigorous clinical trials) to be unsafe and/or ineffective – e.g., Premarin/Prempro for menopausal hormone therapy, which was found in “Women’s Health Initiative Study” to increase the risk of vascular disease. Dismissing almost as irrelevant the legality and propriety of a physician’s medical judgment in prescribing a drug off-label (even in a case where the drug is not only generally and medically accepted, but also included in medical compendia and reimbursable under Medicare/Medicaid), the Government sets the table for (and props up) its legal arguments with the dire warning that unless the FDA’s off-label regulatory scheme is upheld, public health and safety will take a giant step backwards. [Read more...]
Government Censors Its Response to Par First Amendment Challenge; Issues Off-Label Guidance
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. [Read more...]
