Week in Review, April 15, 2013

The PharmaCertify™ Team

“April showers bring May flowers.” And around here, we’re ready for the blooms of May! With any luck, the last gasps of winter passed through last week, and spring is here to stay…for a while anyway. A happy thought to start the week, right? Now that visions of daffodils are dancing in your head, let’s check out what was “dancing” in the world of compliance in this week’s News Week in Review.

According to the American Medical Students Association, everything is coming up roses with conflicts-of-interest policies at medical schools. The latest edition of the AMSA Scorecard, which assesses COI policies of medical schools, showed more schools are improving their COI policies and curricula. Of the 158 schools reviewed, only 13 received an “F” from the organization, and eight of those “Fs” were due to schools not responding to information requests. Of the 158 schools surveyed, 115 received an “A” or “B,” which represented an increase from the previous year’s scorecard. The AMSA said it was pleased to see the increase of schools moving to what it considered a model policy.

Look what the Sunshine helped to create. Industry and physician groups have come together to form Partners for Healthy Dialogues. The group, formed largely in response to the Sunshine Act, supports the transparency that will be brought by the Sunshine Act, and plans to provide background information on how the industry and physicians work together for the benefit of patients. The information will be provided to three main groups: patients, physicians and industry professionals.

And speaking of the Sunshine Act, CMS has posted Fact Sheets for Applicable Manufacturers, Physicians and other stakeholders on the OPENPAYMENTS website. The Fact Sheets provide a summary of information contained in the CMS final rule.

The bloom is off the rose for UK businesses when it comes to checking suppliers for adherence to the UK Bribery Act. A survey from Ernst and Young revealed that 48% of firms are not checking to see if their suppliers are compliant with the UK Bribery Act. The survey covered companies of a variety of sizes, and found 60% firms with turnover of £5-50m did check to see if suppliers were compliant, but of that group, 16% would do nothing if the supplier was not compliant. 40% of companies with turnover of more than £50m said they would stop doing business with suppliers if issues were found.

Pharmaceutical and medical device companies need to be more vigilant than ever when it comes to anticorruption efforts, with the DOJ creating special units to investigate the industry for violations of the FCPA. According to industry experts, life sciences companies draw special attention for three reasons: the heavily regulated nature of the industry; nationalized healthcare systems; and the use of global sales and distribution networks. With enforcement efforts and the resulting fines and penalties increasing, elevating anticorruption programs to match the level scrutiny levied against the industry is critical.

Research from the University of British Columbia showed that 66% of sales representatives are failing to disclose serious side effects of the drugs they detail to physicians. Researchers surveyed 250 doctors in Canada, the U.S. and France between 2009 and 2010. The lead author of research paper noted that in Canada there was no monitoring of sales representative visits, and few sanctions for misleading promotion exist. She noted that due to the increased scrutiny of drug marketing in the France and the U.S., physicians were more likely to hear about side effects.

Rain may start falling on the parade of doctors looking for a free lunch from pharmaceutical companies. According to a report in the Wall Street Journal (sub. req.), a number of pharmaceutical companies are cutting spending on meals and speaker programs. Sales representative layoffs and drug patent expiry were cited as reasons for the reduction in spending related to meals. Companies that increased physician payments were generally doing so in the areas of consulting and clinical research.

Well, that’s it for the News in Review this week. Enjoy the weather everyone – we hope that in between the showers, you find a few minutes to venture out and smell the early blooming roses.

Have a great week everyone!

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