The PharmaCertify™ Team

Sweet! Today is No Diet Day. Now, in all fairness this is not about eating unhealthily, but more about not letting diets consume your life and the importance of what the experts refer to as a “healthy relationship with food.” Good stuff right? Of course, if a cheeseburger happens to make its way into onto our table today, so much the better. So while you contemplate what diet rules you’re going to break this week, we’ll get started with this week’s News Week in Review.

The Executive Director of the Healthcare Communication Coalition, John Kamp, says the FDA needs to develop a new relationship with off-label promotion regulations. As we know, the landmark decision in the Caronia case established the precedence that truthful promotion of off-label uses of drugs was protected by the First Amendment. Mr. Kamp says the FDA needs to re-evaluate its regulations and look beyond the product label when developing a standard of truthful promotion. PhRMA’s General Counsel, Mit Spears, agrees, saying the current standard is too high, considering off-label use of some drugs is the current standard of care and appear in Compendia.

According to a study in PLoS Medicine, Sweden’s model of self regulating drug advertising may not be quite the right “diet” for assuring that ads are not violative. The study analyzed anti-depressant advertising between 1994 and 2003 and found that 34% of the advertising failed a review by the industry’s monitoring group. Study authors say that number should have been higher because their review found ads with exaggerated claims that made it through the review. The authors say that since only a third of the advertising was flagged, there is a problem with the system. They point out that while fines for unethical advertising have risen, they are still too small.

Pharmaceutical and medical device companies may want to start tracking physician spend outside the U.S. as they implement systems to comply with the Sunshine Act. The SEC and DOJ are turning up the heat on FCPA enforcement and healthcare companies may find tracking this data helpful in their FCPA compliance monitoring efforts. In addition, physician transparency laws and polices are quickly popping up around the globe. While the impact of complying with Sunshine is a daunting task, collection of data internationally needs to be a consideration as well.

Australia’s generic drug makers say their prices will feel a lot more bloated if a pending transparency bill is passed. The Generic Medicine Industry Association says the administrative and cost burden would force drug makers to raise the price of the medicine. Other groups complain the bill is too restrictive because it only applies to pharmaceutical companies and not medical device companies. In addition to requiring companies to report spend information, the bill would prohibit companies from paying sponsorships for physicians to attend international medical conferences.

A new study finds physicians aren’t exactly eating up the details of the Sunshine Act. The survey of primary care physicians found that the vast majority were either unfamiliar with the Act or only somewhat familiar. The numbers are somewhat better for principal investigators, with about two-thirds of those surveyed either having a basic understanding of the law or at least having heard of it. Good news on that front though – 77% of principal investigators said the law would not change the likelihood of them participating as an investigator site.

With Sunshine hotter than ever, the DOJ ramping up it enforcement of the FCPA and the FDA holding fast to current drug marketing regulations, now is the time to rethink your company’s compliance training diet. At PharmaCertify, we focus exclusively on commercial compliance for the life sciences industry. Our customizable eLearning modules and iPad apps bring your reps up-to-date promotional and regulatory training where they need it most – in the field and at their fingertips.

Have a great week everyone and enjoy every sandwich!