The PharmaCertify™ Team
The smell of peanuts and Cracker Jack, and the ping of the bat are hanging in the air of Omaha, Nebraska. The College World Series was in full swing this week, and will reach its conclusion, perhaps, over the weekend. Today’s game, featuring the Arkansas Razorbacks and South Carolina Gamecocks (repeat anyone?), will determine who faces Arizona in the finals. As much as we love America’s pastime around here, the games can get a little long. So to keep it interesting, we offer a little reading material – this week’s News Week in Review.
Both of the teams in tonight’s game are members of the SEC. Another SEC (the Securities and Exchange Commission) was making news this week when it gained approval to notify former Siemens executives they were on the hot seat with the US government. The SEC is pursuing civil charges against the executives for violations of the FCPA. The Commission received permission from a federal court to notify the defendants via notices in German newspapers and e-mails to their lawyers. The former executives will have 20 days to respond.
Medicines Australia is voting on a new Code of Conduct. On deck for consideration is the reporting of physician spend information. The measure, which would include the reporting of payments for speaking and hospitality, is supported by many of the industry’s largest companies. Some in the industry fear the measure will discourage doctors from agreeing to speak. As for physicians, the Australian Medical Association says it will not stand in the way of the new Code.
Seroquel (Quetiapine) has been put on waivers by the Department of Defense. Now doctors in CENTCOM will have to sign a waiver to prescribe the drug for troops. The drug is being prescribed, off-label, to deal with insomnia and Post Traumatic Stress Disorder (as are other atypical anti-psychotics). As the use of anti-psychotics rose, evidence began to mount that the drugs could cause irregular heartbeat and even death. Seroquel’s label does warn of cardiac issues. Concern over the cardiac affects and widespread use of the drugs prompted the DOD to take measures to more closely monitor their use, and in the case of Seroquel, restrict the use altogether.
The UK Bribery Act may have been thought of as a home run in the fight against corruption when it was passed over a year ago, but with little legal action occurring since the law went into effect, some have been left feeling a little underwhelmed. Here’s the good news though, the law did prompt action among multinational corporations to get their anti-corruption compliance ducks in a row. That’s good news because according to the OECD’s Working Group on Bribery, the Serious Fraud Office is working on 11 cases and has 18 other cases under consideration. Have you fired up your anti-corruption training yet? If not, we can help.
Directly from the world of baseball (sort of) comes news that a baseball hall of famer, along with a senior Abbott executive, is being investigated by the SEC for insider trading. The investigation stems from the purchase of Advance Medical Optics by Abbott. The SEC believes the former player, along with a teammate and others, profited from advanced knowledge of the sale. The Abbott executive is believed to be partly responsible for leaking the information prior to the purchase.
Worried that the FDA may take you out at the plate if you do the social media slide? Well, your man on the ground, Pharmaguy, reports that the FDA is too busy with all the low hanging fruit in violative product promotion to worry about social media. While attending a conference on social media, Pharmaguy started a discussion regarding meta tags and how the organic search results were essentially branded ads without the required safety information. A supposed expert in the audience said the FDA was too busy dealing with all the low hanging fruit to be worried about such things. Pharmaguy’s belief that the FDA is interested it the issue now is based on a Notice of Violation letter issued to Novartis about its use of meta data and a Facebook share widget.
Well that’s about it everyone. We’re headed out to get the bratwurst started on the grill, and prepare for tonight’s game. Before we go, one more obscure story you may not have heard about. The U.S. Supreme Court decided that drug sales reps do not have to be paid overtime. And someone out there says the decision should not prompt crying among sales reps. (There’s no crying in pharmaceutical sales, people.)
Have a great weekend everybody, and Fear the Fish!