Week in Review, November 4, 2013
The FDA explores the Bad Ad program, targeting misleading drug ads for younger audiences; whistleblower cases shed light on Cephalon kickbacks and the government steps up corruption investigations.

It’s the most wonderful time of the year! When we’re nestled all snug in our beds with visions of sugarplums (or dew drops) dancing in our heads. Finally, Daylight Savings Time came to end over the weekend! Oh, the joy of receiving that precious hour back. We hope you made the most of that “free” hour over the weekend. We sure did! The back of eyelids never looked so good. It’s back to the grind now, so let’s get rolling with this week’s News Week in Review.

The FDA has decided it’s about time to study how teens perceive direct drug advertising. The study will gauge how teens respond to ads for fictitious acne and ADHD drugs. Studies have shown that the part of the brain that helps in discerning risk in decision making is not fully developed until the mid-twenties. The FDA wants to understand how teenagers judge the risk and benefits associated with the drugs in the ads to determine if changes should be made in the way certain drugs are advertised online.

The FDA has sprung forward with a new CME program as a part of the Bad Ad program. The agency will launch a web-based CME program to teach HCPs how to identify misleading drug ads. The course will focus on various types of advertising, and is open to anyone, even though it’s directed to HCPs.

The government will fall back from a pair of whistleblower cases against Cephalon. The first whistleblower case focuses on the off-label promotion of four drugs Cephalon co-promoted with Takeda. This is the second case brought by this group of whistleblowers against the company. The first case resulted in a settlement. In the second, the relator alleges Cephalon promoted three drugs for off-label purposes and paid kickbacks to doctors. The relator also alleges Cephalon and WebMD conspired to locate certain patient populations and promote drugs for off-label use to those patients.

A study by Taxpayers Against Fraud found that for every dollar the federal government spends on investigating and prosecuting healthcare fraud, it recovers $16. The study showed that between 2008 and 2012 civil, criminal and state recoveries were just over $18 billion. The study also showed that since 1987, recoveries totaled nearly $40 billion. China, the U.K. and U.S. are not dilly-dallying when it comes to corruption investigations. Speakers at a conference in Beijing said the countries are stepping up corruption investigations in the food and drug industry. This year, the U.S. government initiated 11 FCPA investigations of drug and medical device companies. According to a former DOJ official speaking at the conference, the agency believes there is considerable corruption occurring in drug firms overseas, and addressing it is a priority with the DOJ. John Tan, counsel with international law firm Reed Smith, said the Serious Fraud Office has six Bribery Act investigations under consideration.

Don’t overlook the importance of having administrative assistants spend time on anti-corruption training. Addressing the question of who should be included in FCPA training, the FCPA Professor points out that while administrative assistants may not interact with “foreign officials” directly, they can be a valuable asset in identifying FCPA risks if they receive training. The article references a recent article in the WSJ about the influence and power admins hold, and points out this should not be overlooked when determining your FCPA training audience.

Well, the clock has run out on another issue of the Week in Review. If all of this news surrounding product promotion has you wondering if your field force is up-to-date on the latest compliance practices, Good Promotional Practices from the PharmaCertify™ suite of customizable off-the-shelf eLearning modules, covers topics ranging from gifts and meals to speaker programs and the handling of off-label inquiries.

Have a great week everyone!