Week in Review, September 3, 2013

The PharmaCertify Team

September has finally arrived! While the temperature says summer is still upon us, fall sports are in full swing. The finale of MLB season is just a few short weeks away, college football opened with a bevy of thrilling games (we’re talking to you Clemson and Georgia fans!), and the much-anticipated NFL season begins this weekend. As you ponder the possibility of your team making a magical run at the 2014 Super Bowl in the league where they play for pay, we offer our picks for the News Week in Review.

We start with that new Titan of regulation in the pharmaceutical industry, the Sunshine Act. In a piece for MedCity News, Dr. Westby Fisher, reveals what he feels are some of the cloudier aspects of the law. Dr. Fisher doesn’t believe patients are really interested in scanning a database to learn what their doctor is receiving from pharmaceutical and device makers, and he points out that the government already holds much of the information on payments to doctors in the form of IRS 1099-R forms. He contends the Sunshine Act casts a light on interactions that have no effect on the costs of drugs and devices, while “back room deals” with insurers, which do have an effect on the costs of drugs and devices, continue.

A Pack of pharmaceutical companies are facing an antitrust lawsuit in Florida. The insurance trust fund of the Ft. Lauderdale Fraternal Order of Police is suing Medics and several other companies for actions that kept a generic version of an acne medication, Solodyn, from the marketplace. The suit contends that lead defendant, Medicis, filed a “sham” Citizen’s Petition with the FDA to delay the approval of the generic. The suit claims that Medics also created alternative versions of the product, in new strengths and had physicians write prescriptions for the new strengths. Impax Laboratories, Mylan and Sandoz are a few of the other companies named in the lawsuit.

All the recent publicity about bribery of Chinese doctors is hardly making the industry look like a bunch of Saints, but perhaps a piece of the puzzle is missing. According to some who work in the healthcare industry in China, Chinese companies, which control 70 percent of the market, are involved in the same behavior as the western companies, yet no Chinese company has been called to task. Analysts speculate that the Chinese government is targeting western companies in order to create a competitive advantage for the homegrown companies. Western companies in other industries, including automotive and technology, are facing scrutiny as well.

The FCPA is no longer the only Cowboy at the anti-corruption rodeo. Over the last several weeks, the Serious Fraud Office in the U.K. and Canadian courts have been busy with anti-corruption cases. The SFO brought its first charges stemming from the UK Bribery Act, and the Canadian Courts found an individual guilty of violating the Corruption of Foreign Public Officials Act. The risk of multiple prosecutions is more pressing than ever for global businesses.

An L.A. retailer may be feeling like a saucy fashion Buccaneer now, but the celebration may be short-lived. The retailer created a line of tee shirts featuring the names of several drugs made by manufactured like Pfizer, AbbVie and Shire. None of the manufacturers granted permission for the names of their drugs to be used on the t-shirts. Pfizer and Shire are considering options for dealing with the unauthorized use of their trademarks. AbbVie, expressed concern that the shirts trivialized the serious health conditions that its drug is meant to treat.

Well that’s it for this short workweek folks. As you plan your 2014 compliance training curriculum this fall, our mobile solutions can help you extend critical compliance content where your learners need it most – in the field and at their fingertips. Contact Sean Murphy at smurphy@nxlevelsolutions.com for a demo.

Have a great week everyone!

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