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…]

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…]

Lilly Scientists Prosecuted For Trade Secret Theft

Two former Eli Lilly scientists were arrested and charged by the U.S. Government for stealing and transmitting Lilly trade secrets to a Chinese company.  Guoqing Cao and Shuyu Li, both research scientists with doctoral degrees, have been charged with multiple counts of trade secrets theft and conspiracy in violation of 18 U.S.C. Sections 1832 and 371, according to an Indictment that was recently unsealed by the U.S. Attorney’s Office in Indianapolis.  The charges against the two naturalized U.S. citizens, who will remain in custody for leaking trade secrets to a Lilly competitor in China, provides an abject lesson for both pharmaceutical companies that fail to safeguard trade secrets and other proprietary information and employees who get caught by federal authorities. [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 Bar and FTC Launch Antitrust Offensive Against Patent Settlements

The Supreme Court’s decision in FTC v. Actavis last June has incentivized a host of direct and indirect payer antitrust class action suits aimed at branded and generic drug manufacturers that settled their Hatch-Waxman patent litigation disputes that included “reverse payments.”  While most of the targeted settlements involved true reverse payments — that is, payments from branded manufacturers to their generic competitors to keep generic versions of products off the market for a period of time — some are taking their cue from the FTC and are challenging patent litigation settlements on antitrust grounds even where no actual reverse payment was made.  From the FTC’s and  plaintiff’s bar perspective, it would appear that any settlement that doesn’t result in immediate generic entry is actionable on antitrust grounds.  But, like so many other positions taken by the Government, does such a viewpoint make common or good policy sense? [Read more…]

Big Pharma On Its Heels as China Rounds Up “More Of The Usual Suspects” And Prepares To Slam GSK

Allegations of misconduct continue to plague Big Pharma companies in China.  Charges of bribery, corruption, off-label promotion, and inflated pricing now extend beyond GlaxoSmithKline (GSK) to Novartis, Eli Lilly, and Sanofi.  While these companies react to coming under Chinese scrutiny — with Johnson & Johnson (J&J) reportedly taking “proactive” steps to strengthen its China unit —  the Company that started it all (GSK) braces for major fines.  [Read more…]