The PharmaCertify™ Team

Now that it is mid-October, the time has come for glitter, glamour, kings and queens. Homecoming! The one game you have to win, and for ladies, the second most important dress you’ll buy that year (it isn’t the prom after all!). Oh, and let’s not forget, everyone loves a parade- except of course the people that are stuck behind the slow moving leviathan clogging up the streets of your town. For many of us it is a time to go back to our alma mater and see old friends, and remember the “good old days.” Let’s begin our own walk down memory lane with some of the news nuggets of yester-week. Now taking the field, this week’s News Week in Review.

Leading off the parade we have a story regarding the FCPA and the life sciences industry. Federal prosecutors and regulators have widened their expectations in third-party due diligence and the oversight that companies need to have over third-parties. The expectation is that companies not only do an initial due diligence, but also look at whether the third-party is capable of conducting business in a manner that measures up to the company’s own FCPA standards. For life sciences companies the sheer number of third-party relationships is staggering, and this need to review third-parties applies not only to new partnerships, but also to already established relationships. Implementing a sound assessment process that encompasses both new relationships as well as ones that are currently active is vitally important.

No more mum corsages for doctors in India from Abbott sales reps. Abbott has implemented a policy temporarily suspending the giving of gifts to doctors in that country. An internal memo says only clinical or scientific literature may be given. The ban even includes minimal value “therapy reminder” items such as pens. Indian law prohibits doctors from accepting gifts or travel, however the law is not consistently enforced. No comment from Abbott as to the reasoning for the decision. In other Abbott news, its $1.5 billion settlement agreement for off-label promotion of an anti-seizure medication was accepted by a judge in federal court.

Are doctors not showing enough spirit for the results of studies funded by the industry? According to one doctor, the skepticism pendulum may have swung too far.  Physicians have become skeptical of the results reported in pharma funded studies as pointed out in a study published in the NEJM. Some skepticism is warranted, but as the doctor points out, physicians have gotten so skeptical that they could be overlooking important safety data by discounting pharma sponsored studies. He suggests that there needs to be more transparency in clinical studies, and suggests greater third-party statistical review and more use of public access sites like clinicaltrials.gov.

The Sunshine Act: the industry’s current homecoming queen. She sure is taking her time putting on her crown and sash to meet the public. While we all wait on the final rule, take a listen to this podcast (written transcript here) from Medsider that discusses the law and its impact on medical device manufacturers. (Much of what is discussed is applicable to those outside of med device as well.) In the podcast the Medsider host and his guest expert discuss a variety of issues including: the purpose of the law, the costs associated with preparing to implement the law, are there any loopholes in the law and what companies need to be doing now to get ready to implement the law. An important point made by the guest is that if companies do not have front-end policies and procedures in place regarding physician consulting agreements, they should seize the opportunity to do this now before their data is publically available. While Sunshine does not require any of this, he says both the government and private attorneys will likely be pouring over the information in the public database. He likens just having your back-end systems and processes in place without addressing this front-end issue to driving a car without car insurance. Nice.

Massachusetts med students want the governor to revisit the past in regards to the provision of meals. A group of med students and consumer advocates, carrying trays of champagne and lobster tails (seriously?), delivered a petition asking the governor to bring back the ban on providing meals at educational presentations outside of a practitioner’s office. The group believes the definition of a “modest meal” is vague, and that these meals do nothing to benefit patients. The group would like to see Massachusetts’ Department of Health set a dollar limit on these meals, ban the serving of alcohol and obtain information about how money for these meals is allocated.

That brings us to the end of this week’s review, but before we put away the crepe paper and streamers we’d like to float one more thing by you: mobile learning. Access is everything, so why not make sure your ethics and compliance training accessible for your learners on their terms? PharmaCertify has a variety of mobile learning solutions to help you put compliance knowledge in the hands of people when and where they need it.

That brings us to the end of the homecoming celebration. We hope you had a good time reminiscing with us. Have a great week and we’ll see you back here next week!