FDA’s Social Media Guidance and the First Amendment – the Next Frontier

Now that Pharmarisc is back up and running, what better topic to discuss than the one that started this blog in the first place back in December, 2012 – the FDA’s incursion into manufacturers’ free speech rights. However, instead of focusing on Caronia, Par, et. al., lets take a look at the FDA’s June, 2014 Guidance re Internet/Social Media Platforms with Character Space Limitations  – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (“June Guidance”) and the free speech implications for manufacturers looking to use Twitter’s wildly popular platform to promote drug and medical device products. [Read more...]

Aegerion CEO’s Remarks On Television Highlight Off-Label Free Speech Issue Once Again

According to the FDA’s Office of Prescription Drug Promotion (“OPDP”), Marc Beer, the CEO of biopharmaceutical firm Aegerion Pharmaceuticals, overstepped his bounds when he allegedly made misleading statements about Aegerion’s cholesterol-lowering drug, Juxtapid™ on two televised appearances on CNBC.   As a result, Aegerion received a warning letter earlier this month from OPDP, admonishing Beer for his transgressions, accusing the Company of misbranding Juxtapid™ and asking for corrective action.  Although it makes business sense for Aegerion to “play ball” with the FDA and do whatever it takes to convince the agency that there was no intent to promote Juxtapid™ off-label, Beer’s comments are a reminder of the free speech issue embedded in any discussion about a drug or device product that falls outside the friendly confines of the product’s labeling. [Read more...]

J&J to Pay $2.2 Billion To End Long-Standing Investigations By Feds

Charges of off-label marketing and kickback payments to physicians and long-term care pharmacy provider Omnicare are behind a $2.2 billion settlement agreement between Johnson & Johnson (“J&J”) and the U.S. Department of Justice (DOJ), in which the global health care giant finally resolves criminal and civil liability involving Risperdal and two other prescription drugs.  The eye-popping figure makes this the third largest health care fraud settlement in U.S. history. [Read more...]

Medtronic InFUSE Cases Signal That Off-Label Promotion Probably Not Illegal

A majority of plaintiffs seeking damages based on off-label promotion of Medtronic’s InFUSE Bone Graft system have been stopped in their tracks following several recent federal court decisions holding that such challenges were barred on preemption grounds.  Indeed, with the exception of two district court cases out of the Ninth Circuit, these preemption rulings not only underscore the limits of off-label promotion arguments in medical device cases, but also show that courts remain skeptical about whether off-label promotion is illegal under federal law. [Read more...]

Plaintiff’s Lawyers File RICO Class Action Suit Against Abbott Over Depakote Off-Label Promotion

A well-known plaintiff’s law firm with a stable of union pension fund clients has used the Racketeering Influenced and Corrupt Organizations Act (“RICO”), which was originally enacted in 1970 to combat organized crime, to file a class action lawsuit against Abbott Laboratories for the off-label promotions of Depakote.  Unless Abbott and similarly situated big pharma companies intend to fork over hundreds of millions (if not billions) of more dollars to plaintiff’s lawyers, they need to fight such suits tooth and nail. [Read more...]

Pfizer $149 Million Rapamune Settlement Is More Proof That It’s Business As Usual With The Feds

Two False Claims Act whistleblower lawsuits are being resolved as part of a $491 million settlement between Wyeth Pharmaceuticals, now a division of Pfizer, Inc., and the U.S. DOJ.  This time around, Wyeth’s misconduct was based on off-label sales tactics for Rapamune®, an immunosuppressive drug that FDA approved for use in renal (kidney) transplant patients.  Unfortunately for the pharmaceutical industry, Pfizer’s latest compliance woes are a stark reminder that off-label cases are anything but passé.   [Read more...]

Navigating FDA Guidance on Facebook and Social Media

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...]