The PharmaCertify™ Team

It may have been a day late, but the need for speed was met early this week at NASCAR’s premier and premier race – The Daytona 500. The first race on the season schedule turned out to be quite a spectacle, with more delays, twists and turns than anyone could have expected. What a start! We’re all revved up and ready to run here at the News Week in Review as well. So, ladies and gentlemen, start your engines.

Let’s start the ride with a story from overseas. We all recall the less than mind blowing first prosecution under the UK Bribery Act. Well, our collective minds may be blown in the near future as the Serious Fraud Office (SFO) has several active investigations for possible infractions of the Bribery Act, according to a UK lawyer.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) gave the green light to a strengthened code that will ensure “the highest ethical and professional standards.” The new code covers interaction with healthcare professionals, patient organizations and medical institutions. It also clarifies the line between appropriate and inappropriate forms of support. Provision of entertainment is reduced to only include entertainment provided when the interaction between the drug company and physician are of a scientific or educational nature.

Representatives from 20 different medical device industry trade groups raced over to Washington, D.C. this week to meet with lawmakers. The topic: repealing the medical device tax due to be implemented next year as a part of the healthcare reform law. On the other side of the Hill, House democrats introduced legislation that would give the FDA the power to reject devices with designs based on products that were recalled for safety concerns. Jeffery Shuren, the head of the FDA’s Center for Devices and Radiological Health, says the FDA not having the rejection authority creates a loophole and challenges the credibility of some device approvals.

The sun sure wasn’t shining in Daytona for the race, but the Sunshine Act was hot…both here and abroad. A call has come from India for a law similar to the U.S.’s Sunshine Act. According to a doctor from the Monthly Index of Medical Specialties, the Medical Council of India has a ban in place prohibiting doctors from accepting “bribes” from pharmaceutical companies; however there is nothing prohibiting the pharmaceutical company from offering the bribe. The country does have the voluntary Uniform Code of Marketing Practice in place but the doctor believes a law with penalties for companies that violate MCI rules is needed.

A survey conducted by GSK in Australia found that the majority of respondents did not like the notion of their physicians receiving payments from drug companies and were in favor of the companies having to reveal those payments. However the objection melted away when context was given as to why the physician was receiving the payment.

Nearly 100 physician groups here in the U.S. have essentially black flagged the CMS’s proposed rules for dispute resolution under the Sunshine Act. The groups are concerned that the rule, as it currently stands, does not do enough to protect the reputation and integrity of physicians. They have advocated for the appointment of an independent arbiter to handle disputes in reported payments.

To that end, a teacher of medical ethics at Davidson College says the hidden cost of the Sunshine Act is really the loss of valuable interactions between industry and physicians. The author of the editorial in USA Today says the law stigmatizes the financial relationship physicians have with the industry. He fears physicians will raise their rates to participate in activities that will be reported under the Sunshine Act, in order to compensate for the loss of anonymity and the presumption of corruption.

A medical student at the Oregon Health and Science University (OHSU) has started an online petition to have the university prohibit physicians affiliated with the institution from participating in pharmaceutical speaker’s bureaus. The student, a former pharmaceutical company employee, feels participation in these bureaus presents a conflict of interest for those attending the speaker programs and their patients. Current rules at OHSU require physicians to have final approval over the content of any speeches prepared by someone in the industry and earnings over $10,000 be reported.

Well folks, we’re in the last lap now and headed for the weekend! Before we go, remember, with so many of your colleagues racing around in the field, you need compliance information and training that is accessible on the go as well. We can help with iPad-compatible modules and just-in time reference apps that bring up-to-date compliance content and training to your learners.

Have a great weekend, and we’ll see you right back here next week.