French Sunshine Act | Compliance Training Intelligence

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!

The PharmaCertify™ Team

It’s unofficial…summer is here! Despite what the astronomers or school calendars say, summer has begun as far as we are concerned. Time to fire up the grill and drag the pool gear out of storage. As you contemplate all of the important decisions of the season, like whether to go with mustard, sauerkraut or both at next weekend’s barbeque (FYI…ditch the sauerkraut and go with cole slaw, you’ll thank us later), we present this week’s News Week in Review.

The sun has finally risen over France. The so-called French Sunshine Act went into effect last week. The law is similar to the U.S. version (a public website will be established for the reported information), but it contains some key differences, such as the requirement to report items of values provided to medical students, and the inclusion of manufacturers of cosmetics and tattooing products. The French law is retroactive to 2012. (Yikes!) It applies only to products regulated by France’s Agence nationale de sécurité du medicament et des produits de santé, which only has jurisdiction over products produced and distributed in France. So, until more information is provided by French authorities, the presumption is that the law only applies to domestic companies.

Some U.S. drug and device manufacturers need to get out of the shade and step in to the Sunshine. A recent survey found 62% of manufacturers are capturing the data needed to comply with the Sunshine Act. Of the remaining 38%, most are capturing data needed to comply with state laws and plan to do the same for Sunshine. The same survey revealed that almost 30% of companies require sales representatives and MSLs to obtain signatures when they distribute a reprint in response to an unsolicited question regarding the off-label use of a drug.

The temperatures are rising and so is the spending on digital marketing by pharmaceutical companies. According to a white paper from Compass, a media buying company, about 40% of the money spent to reach HCPs this year will be focused on digital channels. Professional marketing budgets are down, so the rise in use of digital channels is not surprising considering the cost of print. Companies aren’t shifting to digital channels for the distribution of reprints but the amount companies are spending on reprints has been dropping between 20 and 40% per year. Uncertainty around digital rights management is largely to blame, but Compass expects the use of e-prints to double in 2013 as more companies move to tablet based detailing.

According to a compilation prepared for the Financial Times, leading pharmaceutical companies paid one billion dollars to physicians last year (now that’s a lot of sand dollars). The compilation covered a dozen companies, and included expenses for research, consulting and entertainment. While the total figure shows an increase over previous years, it should be noted that the list of companies that disclosed their payments grew in 2012. Companies reporting like-for-like spend actually decreased their physician spend in 2012 over 2011. Medical device companies reported spending $188 million on physicians, the majority of which was for royalty payments.

The Washington Legal Foundation (WLF) is looking to apply some Sun(shine) block. The foundation submitted comments to CMS regarding the decision to not include textbooks on the educational items exclusion list. Since textbooks exceed the $10 threshold, manufacturers will have to track each one, and physicians will need to keep records as well in order to be prepared to review and potentially dispute the information. Further, the law places financial penalties on manufacturers for failure to report the items, whether intentional or not. The WLF argues that the decision will result in a “significant reduction of free speech,” as fewer textbooks are disseminated, as manufacturers work to reduce the compliance burden and risks.

The ACCME is ready to throw some new accreditation standards on the grill. The new accreditation criteria are intended to streamline the process and strengthen support for CME. Advertising, including corporate logos and product trade names, are not allowed to appear in educational materials distributed at a CME program. Likewise, disclosure statements cannot include corporate logos or product trade names.

The Sunshine Act was certainly a “hot” topic this week in the News. With data collection just around the corner, the news about Sunshine is not likely to cool down anytime soon. PharmaCertify now offers a customizable, off-the-shelf eLearning module covering the details of the law, along with a new iPad app, to keep your staff up-to-date, with Sunshine content where they need it most – in the field and at their fingertips.

Have a great week everyone.

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