ISTA Pharmaceuticals, Inc. (“ISTA”), a unit of eye care giant Bausch + Lomb (“B&L”), recently agreed to a $33.5 million Government settlement involving civil and criminal charges. The conduct underlying the settlement pre-dated B&L’s acquisition of ISTA in June, 2012 and underscores once again that when it comes to these kinds of settlements, it’s better for companies to play ball and let the Feds have their press release. [Read more...]
Form Over Substance: Bausch + Lomb’s ISTA Pharmaceuticals Unit Settles with U.S
June 6, 2013 By Leave a Comment
Government One-Two Punches Novartis and Exposes Dangers of Speaker Programs
May 9, 2013 By Leave a Comment
Late last month, the Government stung Novartis with separate False Claims Act (FCA) suits only days apart. On April 23rd, the Government charged that Novartis paid kickbacks to numerous pharmacies in the form of discounts and rebates in order to induce the pharmacies to switch kidney transplant patients to Novartis’ Myfortic® from rival branded and generic drugs. And while that case presents a good blog topic in its own right, it is the Government’s second case that should really make everyone stand up and take notice. In the April 26th FCA Complaint, the Government reveals that Novartis spent $65 million on 38,000 speaker programs from 2002 through 2011 in support of sales for the hypertension drugs Lotrel® and Valturna®, and the diabetes drug Starlix® and has charged that the Company’s Speaker Programs were essentially nothing but kickbacks, providing little or no educational value. The problem is that much of what happened at Novartis has happened (and may well continue to happen) elsewhere. [Read more...]
First Circuit Slams Pfizer in Three Neurontin RICO Suits; Affirms $142 Million Verdict
April 18, 2013 By Leave a Comment
Pfizer, Inc., must pay a $142 million jury verdict to Kaiser Foundation Health Plan, Inc. (“Kaiser”) for “damages” related to the off-label promotion of Neurontin®, the First Circuit ruled last week. Unfortunately, for Pfizer and other companies that have pleaded guilty to misbranding violations based on off-label promotion, the First Circuit’s ruling could spell even more trouble ahead. [Read more...]
Navigating FDA Guidance on Facebook and Social Media
March 18, 2013 By Leave a Comment
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
January 31, 2013 By Leave a Comment
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
December 21, 2012 By Leave a Comment
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!
December 4, 2012 By Leave a Comment
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 II
October 31, 2012 By Leave a Comment
In my last post, I discussed how generic manufacturers use the practice of “skinny labeling” to get a free ride on a branded drug’s unexpired method of use patent. As I explained, when a pioneer drug has multiple indications, each of which is protected by a separate method of use patent with its own expiration date, the generic drug manufacturer can avoid having to incur the considerable expense and risk in challenging the validitiy and enforceability of the unexpired method of use patent by submitting a “section viii” statement with its ANDA. By side-stepping a Paragraph IV certification under Hatch-Waxman, the generic manufacturer not only avoids the risk of an adverse ruling and losing millions of dollars in patent infringement litigation, but ends up selling its skinny-labeled drug for the patent-protected use anyway because of mandatory and permissive “substitution” rules that require/allow generic substitution of cheaper “AB” rated generic drugs for branded drugs. While a skinny label free ride is great for the generic drug industry, the innovator drug industry is caught in the horns of a skinny label dilemma: should it continue to invest and lose billions of dollars in clinical research getting FDA approval of current off-label uses (knowing that as soon as the patents on a drug’s compound and original indication(s) expire, the drug will get skinny labeled), or forego the investment and face the possibility of investigation and prosecution for off-label promotion of those uses? [Read more...]
Generic Skinny Labeling – A Different Kind of Off-Label Promotion – Part I
September 25, 2012 By Leave a Comment
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
May 9, 2012 By Leave a Comment
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...]
