News Week in Review, March 10, 2014

Pharmaceutical companies cut spending on physician speakers,  the DOJ turns up the HEAT, China ups the stakes on the bribery front, and the value of a reprint under Sunshine is still unclear.

Hey, wake up! The transition to Daylight Saving Time is such a drag…on our energy that is. Soon enough, we’ll all be excited about the extra daylight hours, but right now, we’d settle for some extra caffeine. To help you find your set point and adjust your internal clock, we offer our regularly scheduled overview of all things compliance…with this week’s News in Review.

The amount pharmaceutical companies spend on physician speakers is not exactly spring forward, according to an analysis of Pro Publica data. In fact, several large companies have dramatically cut spending on physician speakers, which some attribute to the transparency requirements of Sunshine. The companies offer a different rationale though. A spokesperson for Lilly says educational programs are of most value when a product is launched, or new clinical data is released. Additionally, as web conferencing increases, the need for speakers declines. A spokesperson for Pfizer points out that as blockbuster drugs go off patent and face generic competition, the need for educational programs and speakers for those drugs wanes.

Spending on drug marketing is on the rise in Washington D.C., according to a report by the George Washington University School of Public Health and Health Services. In 2012, companies spent $97.5 million on drug marketing, which represented the first year-on-year increase since 2007.

As spring draws near, and the temperatures rise, the DOJ continues to provide some HEAT of its own with the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative. Using the False Claims Act as its primary tool, the agency has recovered $13.4 billion from individual providers, pharmaceutical companies, and medical device companies.

Takeda would like to turn back time after the company admitted using “inappropriate expressions” in an advertisement for its hypertension drug, Blopress, in Japan. A Japanese physician noticed that data presented in the advertisement was not consistent with the results of a head-to-head study with a competitor’s product. The company admitted that using a graph from a 2006 study in the advertisement could have caused confusion.

Speaking of losing sleep, life science executives may be lying in bed at night thinking about the increasing challenges of doing business in China. Officials in China announced that companies found to have committed bribery will be blacklisted and updated the country’s “Rules on the Establishment of Commercial Bribery Blacklists for Purchase and Distribution in the Health Care Industry.” Circular No. 50, which delineates the updates to the rules, states that a company may be blacklisted for several reasons, including minor instances of bribery that are not prosecuted by authorities. If blacklisted, hospitals and other facilities will be prohibited from purchasing goods in the province where the bribery occurred for two years. Companies blacklisted two or more times in five years will be prohibited from selling its products in the country all together.

A new study shows drug makers are not quite ready to crawl out from under the covers when it comes to using social media for clinical studies. The study conducted by the Tufts Center for the Study of Drug Development (CSDD) found that companies using social media in the clinical research process are doing so in a “siloed and experimental fashion.”  Lack of guidance from the FDA and concerns about the impact of social media on study integrity are cited as factors slowing the adoption of social media for clinical trials.

What’s a Daylight Saving Time theme without at least one reference to Sunshine. With little in the way of guidance from CMS, companies are taking various approaches to determining the value of journal reprints under the Sunshine Act. Some companies follow what CMS has stated, and value a reprint at the cost the company paid to acquire it from a publisher. Other companies use a blended average model and some hire a third party to determine the value of their reprints. Complicating the matter further, doctors are starting to refuse reprints because they see them as taxable form of income.

As the sun sets much later in the day, and on this week’s News in Review, we close with a reminder that the PharmaCertify™ online learning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers the topics your learners need to understand, like disclosure requirements and excluded payments, to stay abreast of this industry-changing legislation.

Have a bright and sunny week everyone!

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