The PharmaCertify™ Team

Time is a ticking on summer with Labor Day just around the corner and now is the time to squeeze in those final cookouts and road trips. Of course, any proper barbecue or cross country trip wouldn’t be complete without a list of great summer tunes. Remember that great anthem that you heard all summer long and brought back great memories when you heard it years later? Well, as you start building this year’s Labor Day weekend playlist of guilty pleasures, we have a bit of “list” to tune up ourselves, the News Week in Review.

There’s been a British invasion over at Shire as the company joins the Association of the British Pharmaceutical Industry (ABPI) as a full member. Regarding the decision, company representatives said, “we seek to play a role in the development and growth of our industry, so joining the ABPI will be one way of contributing to this.”  Shire will also have a representative joining the ABPI Board of Management.

Two congressmen are not singing the praises of the current 510(k) approval process for medical devices. In a letter to the head of the FDA’s Center for Devices and Radiological Health, the pair expressed concern that faulty medical devices are able to reach the market through a loophole in the 510(k) approval process. The congressmen would like to see the FDA’s authority extended to deny approval for devices with designs that are based on devices that have previously been recalled.

On the legal front, former baseball star, Eddie Murray, and Abbott executive, James Mazzo, were indicted by the SEC on charges of insider trading related to the purchase of Advance Medical Optics by Abbott. Mr. Mazzo, former CEO of Advance Medical Optics, is alleged to have shared non-public information regarding the sale with one of Murray’s teammates. Murray learned of the sale from the teammate and profited from the inside information. Mr. Mazzo denies the allegations while Mr. Murray has agreed to a settlement with the SEC, but has denied any wrongdoing.

A former employee at Abbott is whistling an interesting tune about the company’s marketing practices for its cholesterol drug, TriCor. A new whistleblower case has been filed alleging the company used misleading and off-label marketing practices and provided kickbacks to doctors, which all led to Medicare and Medicaid paying for unnecessary prescriptions.

The definition of a foreign official under the FCPA, an oldie but goodie, was making the rounds on the anti-bribery playlist last week. This time, the case involves a Haitian telecommunications company. One of challenges to the defendants’ conviction centers on whether Haiti Teleco could be considered an instrumentality of the government simply because Haiti’s national bank owned a majority of shares in the company. In its brief, the government said 97% of the telecom company is owned by the bank, thereby making it an instrumentality of the government. The government also said the defendants could have requested an opinion from the DOJ as to whether the telecom company counted as an instrumentality.

Boehringer Ingelheim wants to “blind you with science,” but not in the typical fashion. Rather than announcing a breakthrough drug, the company announced they launch a social game that lets players run their own lab. The game, Syrum, is scheduled for beta trial in September. The company says they developed the game to educate “players about the pharmaceutical industry in a fun and engaging way.”  Game on!

And so we’ve reached the end of our playlist. If you’re like us, you’ll soon be breaking out the seersucker suit and white shoes for one final spin as you relish the memories of another summer season? Have a great week everyone. Enjoy the Labor Day festivities!