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...]

Pharmarisc Is Back

Dear Pharmarisc readers:

My sincere apologies for my long absence and lack of blogging these past several months.  Unfortunately, pressing work and family obligations and making the transition from a big, mostly IP, law firm to a small law firm boutique in Boston (Laredo & Smith, LLP), absorbed much of my time and prevented me from writing and commenting upon news affecting the life sciences and healthcare industries. Now that I’ve settled into my new compliance and white collar defense law practice, I will do my best to blog with the type of regularity Pharmarisc readers recall and have come to expect.  Moreover, because the focus of my practice now includes more traditional white collar work and compliance counseling, expect Pharmarisc to go beyond the life sciences industry and cover Medicare/Medicaid fraud and other white collar topics.

I also want to recognize and thank Vinita Banthia, a law student in Minnesota, for helping me with research for the next few posts.

 

Jose Sierra

The Patent Troll Threat To Pharmaceutical Companies

In recent months patent litigation abuse by so-called “patent trolls” has gotten the attention of lawmakers, state attorneys general and even President Obama, who called for patent litigation reform during his State of the Union address. And, while the primary targets of such litigation abuse so far have been technology companies, a recent study cited in Law360 warns that in the absence of patent reform legislation, patent trolls will soon set their sights on bio-pharmaceutical companies. [Read more...]

Cash-Payment Rule Needed For Pay-For-Delay Litigation Frenzy

The fallout from the Supreme Court’s decision last Summer in FTC v. Actavis remains unabated as a host of purported classes of direct and indirect drug payers continue to file suits against branded and generic manufacturers for settling their Hatch-Waxman disputes in deals involving delayed market entry of cheaper, generic drugs.  While some of the settlements involved a genuine cash “reverse payment” from the branded to the generic manufacturer, as was the case in Actavis, settlements lacking any cash payment are also under attack.  However, a recent dismissal of a pay-for-delay federal suit in New Jersey on the basis that no cash reverse payment was involved will likely cause the Third Circuit and perhaps eventually the Supreme Court to decide whether Actavis’s antitrust “rule of reason” approach can and should be applied to non-cash reverse payment settlements.  [Read more...]

Government Slams Ranbaxy Again Over Plant In India

Last week the FDA announced that Ranbaxy’s Toansa plant in India failed inspection — the sixth Ranbaxy plant to cease making drugs for the U.S. market following revelations from a whistleblower that the generic drugmaker had flagrantly disregarded cGMP regulations in its manufacturing facilities.  Is this latest enforcement action nothing more than proof that Ranbaxy remains in the agency’s crosshairs, or is it yet another signal that the Government intends to ramp up cGMP-based FCA actions against pharmaceutical manufacturers? [Read more...]

Will GSK’s Incentive Compensation And Speaker Program Initiatives Set The Tone For 2014?

When British drug giant GlaxoSmithKline PLC (“GSK”) announced last month that it was implementing a new global marketing strategy to transform the way it sells and markets drugs to both doctors and patients, many commentators were quick to announce that a fundamental shift in the pharmaceutical business was underway.   While GSK’s announcement was significant in terms of precedence and scope, it is unclear at best whether other pharmaceutical companies will follow suit. [Read more...]

Feds Raid Reckitt Benckiser Offices; Criminal Probe Underway

Reckitt Benckiser’s offices in Richmond, Va., were raided by a team of IRS and Office of Inspector General (OIG) agents on December  3rd.  The raid comes only a few weeks after the New York Times published an article on November 16 about the incongruity of Reckitt Benckiser’s wonder drug, Suboxone—positioned as both a helpful medication that treats addiction and a potential street drug that fuels dependency.  For the U.K. consumer goods giant, last week’s raid isn’t just more bad news – it’s the worst kind of news any company can get.  [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...]

FDA Proposed Rule Would “Preempt” Supreme Court Rulings in Pliva and Bartlett

Last week the FDA announced a proposed Rule that would put generic manufacturers on the same “products liability” footing as branded manufacturers.  By requiring generic manufacturers to update their labels to take into account new safety information, the FDA rule would effectively overrule the Supreme Court’s holdings in PLIVA v. Mensing and Mutual Pharmaceutical Co., Inc., v. Bartlett, which effectively barred most state law products liability suits against generic drug manufacturers on federal preemption grounds. [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...]