The PharmaCertify™ Team

A 168 year old paper printed its last edition on Sunday, July 10. Another casualty of the Internet age? No, a casualty of an ethics breach so grave that it caused the paper to shut down. Of course we’re talking about the British tabloid, News of the World. We want to assure you, our dear readers, that we have not engaged in phone hacking or bribery here at PharmaCertify™ Week in Review. Okay, enough of that tangent and on to this (past) week’s news in review. It’s past because this one’s a little late. A big thank you to our readers who asked about this addition and alerted us that we had a problem! So, here we go.

Approved! The DOJ issued an advisory opinion regarding paying for trips of foreign officials. The agency cited previous guidance that approved payment for travel in certain circumstances where travel was acceptable, because it was used specifically to promote, demonstrate or explain the requesting companies’ offerings. The DOJ cautioned that this opinion did not represent a blanket approval for other companies in similar circumstances. Clear as mud. Thanks!

Caught on tape! Excessive hospitality provided by a pharma company during a medical congress in Spain. And that was just one of several companies cited in a Prescriptions Medicine Code of Practice Authority report. The hospitality in question was provided to healthcare workers from the UK’s National Health Service. Now these companies may find themselves being investigated by the Serious Fraud Office, under new powers granted to the organization through the UK Bribery Act.

Confession! A doctor relays his personal experiences with pharmaceutical sales representatives; from accepting a consulting offer that included a free trip to the unintended consequences of his decision to no longer see sales reps. The doctor also discusses current transparency efforts and the need for more regulation.

Violated! Canadian cosmetic surgeons have been warned that prescription drug information posted on their practice websites is considered marketing and is in violation of laws that prohibit the marketing of drugs to consumers.

Getting cozy! Cozying up to the pharmaceutical industry, Google may have solved some of the trepidation pharmaceutical companies face in embarking in social media. AstraZeneca raised concerns that the videos popping up in the suggestions column of the YouTube Channel they were developing were not ones they wanted associated with their brand. Google developed a feature through which channel owners with a certain number of videos can control what videos appear in the column.

Denied! The appeal of a compliance officer’s wrongful termination suit was denied by the 8th Circuit Court of Appeals. The CO accuses her employer of having fired her over reporting concerns that the company was violating CMS requirements.

No Comment! Or comment if you feel so moved. The FDA is seeking public comments on its plan to remove a portion of PDMA regulations that require unauthorized distributors of drugs to provide the purchase history of the drugs they sell to their customers. The history, also known as a pedigree, traces the sale, and trade of drugs starting from the manufacturer through to the unauthorized distributor.

Enough! A panel of healthcare lawyers discussed the direction of health care fraud and enforcement at a forum hosted by Main Justice. One of the panelists commented that enforcement has moved from straightforward cases of wrongdoing to complicated cases where it is not even clear if items such as kickbacks were provided. They claim companies are subsequently having difficulty complying with the law.

Finished! Here we are at the end of another PharmaCertify™ Week in Review. But it isn’t the end of the compliance training tools we offer here at PharmaCertify. We’re here to help with your training needs on topics such as the FCPA, PDMA and the False Claims Act. Check us out at www.pharmacertify.com.

Keep cool!