Only a few months after agreeing to fork over $109 million in civil penalties related to charges that the Company had provided free samples of the knee injection drug, Hylagan, to physicians as kickbacks for prescription business, Sanofi-Aventis has admitted in SEC filings that it is once again under DOJ Investigation. Although the details are sketchy, Sanofi’s disclosures to the FDA about the variability in patient responses to Plavix — the blood-thinning, anti-clotting drug that had been a blockbuster for Sanofi and its marketing partner, Bristol-Myers Squibb (BMS), prior to losing patent protection in 2012 – is at the heart of the investigation. [Read more...]
We hoped for the best and feared the worst. As is usually the case when it comes to the Government, our fears came out on top. Last Wednesday, the Government announced that Par Pharmaceutical Companies Inc. had pleaded guilty to civil and criminal charges relating to the company’s alleged off-label marketing of Megace ES in violation of the Federal Food, Drug and Cosmetic Act (FDCA). Now that the Government has decided to “skip” the opportunity to defend its myopic view of the First Amendment before the Supreme Court, by not appealing the Second Circuit’s decision in U.S. v. Caronia, and has succeeded in beating Par into submission, is it business as usual in the world of off-label marketing? It appears that way. [Read more...]
In a recent federal district court case, U.S. District Judge Rya W. Zobel ruled in U.S. ex rel. Constance A. Conrad v. Abbott Laboratories, et. al., No. 02-11738, that because the plaintiff relator’s qui tam complaint could have been pieced together from public sources, the court lacked subject matter jurisdiction over the matter. As a result, the court granted the defendants’ motion to dismiss the complaint, breathing some life back into the public disclosure defense as a jurisdictional hurdle for would-be whistleblowers — a defense that the Affordable Care Act of 2010 (“ACA”) seemed to seriously restrict. [Read more...]
Dear PharmaRisc Readers,
I am writing to notify you of some upcoming enhancements to the PharmaRisc blog.
As you know, the goal of this blog is to bring you news of legal, compliance, and corporate governance issues facing pharmaceutical and other life science companies. Blog articles are particularly focused on the elements of “RISC” – Reporting, Information Systems and Controls.
Starting this month, you will be receiving more frequent blog posts on RISC-related topics in the pharma and life sciences industries. In addition to commenting on recent court cases and regulatory guidelines, I will start to provide insight into practical issues that a life sciences company and its executives must address when dealing with a whistleblower, qui tam, or False Claims Act investigation. [Read more...]
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...]
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...]
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...]
After years of waiting, companies doing business overseas got an early holiday gift from the Feds on November 14th — the long-awaited guidance on the FCPA. Unfortunately, the 120-page document entitled A Resource Guide to the U.S. Foreign Corrupt Practices Act (issued jointly by the DOJ and SEC) is much like that beautifully wrapped large gift one often finds under a Christmas tree: as the wrapping paper is torn and the box’s contents inspected, the excitement dwindles when the recipient realizes he got the same gift last year . . . and the year before. [Read more...]
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...]
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...]