The PharmaCertify™ Team

Are you ready for the World Series? The College World Series, that is. The CWS starts this weekend in Omaha, Nebraska of all places and the college sports fans at PharmaCertify are thrilled. As we ready our rally caps and foam fingers, we invite you to enjoy this week’s News Week in Review.

First up to the plate this week is news that a whistleblower case against Boston Scientific is officially allowed to move forward. A judge denied the company’s motion to dismiss the case, disqualify the plaintiff’s attorneys and strike information it deemed confidential. The whistleblowers are accusing Boston Scientific of promoting a spine product for off-label uses and defrauding Medicare and Medicaid.

Abbott didn’t exactly get a friendly call from an “umpire” this past week.  A federal judge ruled that a shareholder suit against the company, involving the marketing of Depakote, will move forward. The judge required the shareholders to show that any efforts they would have made to get the Abbott Board of Directors to deal with misconduct in the company would have been futile. The shareholders amended their complaint and Abbott’s motion to dismiss the suit was denied. The shareholders are seeking monetary damages and a court order that would require the company to improve its corporate governance program. A company spokesperson said the company disagreed with the decision and that “we continue to believe the case is without merit.”

The U.S. House of Representatives wants better scorekeeping on the movement of drugs through the supply chain. The House passed the Safeguarding America’s Pharmaceuticals Act. The track and trace bill aims to deal with theft, counterfeiting and re-entry of adulterated drugs into the supply chain. Don’t start fretting yet over how to comply though. According to the House bill, “enhanced” regulations don’t need to be in place until 2027, and it will not require unit level tracking. A similar bill in the Senate requires unit level tracking to be in place in 10 years. The Senate bill could come up for a vote later in the month.

Got questions about Sunshine? Both CMS and AdvaMed are offering some coaching. CMS released more FAQs this past week. Notable was an FAQ about whether a textbook should be classified as a gift or education. The answer is clear as mud – it depends. Well, that was helpful, thanks. AdvaMed is offering two workshops about the Sunshine Act and its impact on the medical device industry. Topics include reporting requirements, preparing assumption documents, handling disputes and trends in global transparency.

State Attorneys General are calling strike two on Google. According to the AGs, Google continues to serve up ads for illegal Internet pharmacies. Several years ago, Google paid $500 million to settle charges with the government over this same issue. According to the AGs, pharmacies known to sell counterfeit drugs turn up at the top of Google keyword searches. Further, the pharmacies are showing up in Google ads and have been permitted to post videos on YouTube, which is owned by Google.  Google says it is fighting the problem. The company claims it has removed millions of ads for illegal pharmacies over the last two years, and routinely removes videos from YouTube. The AGs have invited the Google CEO to a national meeting to discuss the matter.

According to a new study, accredited CME is a sure homerun in the fight to reduce healthcare costs. Due to the expensive and time-consuming follow up needed, studies on the economic impact of CME are rare. In this case, researchers used computer modeling to examine the potential economic impact if cardiac thoracic surgeons were to use information they learned related to bleeding complications. The study showed that if 30% of the surgeons used the information to prevent bleeding in 2% of their surgeries throughout the year, the savings would be between $1.5 million and $2.7 million.

Well, it’s about time to call in the closer and wrap up this week’s Review. One last pitch – if you’re expanding your company’s compliance training beyond sales and marketing, PharmaCertify’s Commercial Compliance Overview mohdule covers the critical topics your entire staff needs to comprehend, like the Anti-kickback Statute, off-label promotion and the False Claims Act. Drop us a note, we’d be happy to send you a content outline or show you a demo.

Have a great week everyone…and go team!