The PharmaCertify™ Team

Congress is on vacation. The President is on vacation. The person in the office or cubicle next to you is on vacation. Yep, lots of vacation going on right now, but you know who isn’t on vacation? That’s right, the PC News Week in Review! Let’s get the ball rolling on this week’s review.

Will Pharma stay in the water when it comes to Facebook? ‘Tis the question of the week. Companies like J&J and AstraZeneca have pulled Facebook pages, where others like Pfizer and Sanofi are staying in. The industry is concerned about dealing with adverse event reports, off-label information and medical advice that appear in the comments. Some outside the industry say the concern is manageable and the industry is being overly cautious, and the FDA, well…

Turning a lovely shade of red, but not from a sunburn, is Bayer. The Prescription Medicines Code of Practice Authority (PMCPA), the watchdog arm of the Association of the British Pharmaceutical Industry, issued a reprimand against the company for improper promotion over tweets on two of the company’s drugs. No fines were levied against the company, but the reprimand will be published in medical journals.

The industry is taking a bit of a “staycation” when it comes to support of CME. According to the ACCME, industry support of CME fell for the third straight year as industry funding made up just 37% of income for CME providers. Companies are also spending less when it comes to advertising and exhibits at CME events. All of this comes as the number of doctors seeking CME is increasing.

The Office of Civil Rights (OCR) may be making a trip to court to collect $4.3 million in fines owed by Cignet Healthcare for violations of HIPAA related to refusing to provide 41 patients with their medical records. The case marks the first instance where the agency has not been able to negotiate a deal with a covered entity. OCR officials are stunned at Cignet’s refusal to even show up at court hearings in the matter. What is up with that? Were they afraid they would have to listen to a timeshare presentation or something? Don’t know why we should be surprised since they responded to fines by delivering 4,500 patient files to the lobby of the DOJ. Wow…just wow.

PhRMA tells the FDA it’s time to pack up the current drug name changing process. In response to an FDA request for comment, the group said the current process should be scrapped or overhauled to streamline the process. A drug safety organization says name confusion is the most common cause of medication errors, and the name testing program is an important safety measure.

The ACCME retreats on a proposal to not allow corporate logos appear on commercial support disclosures. The group asked for comment on the issue. The majority of respondents were not in favor of the move, saying that “text only” disclosures could be buried or simply overlooked, while logos increase transparency and offer a visual indication of who has paid the support.

Carl Ichan’s nominees for Forest Labs’ board of directors can hit the road, as it doesn’t appear they will be serving on the BOD any time soon. Early results in voting point to the nominees put forth by Forest as the winners of the election.

If your summer reading plans include medical journals, be wary of the pharmaceutical ads. A study that reviewed nearly 200 ads in medical journals found that less than 20% of them are completely compliant with FDA guidelines on advertising. The study authors point to a lack of resources at DDMAC as the reason for the problems in regulating the ads.

And speaking of reading, we wind up this week with a story that could have been ripped right out of your favorite vacation guilty pleasure read. A Mexico City lawyer representing Baxter International in a case against a trucking company was “caught on tape” offering to pay off an expert witness for the opposition. Baxter said the offer was not authorized, and the lawyer was no longer representing the company in the matter. For interesting read on whether the FCPA could be implicated in the matter, check out this blog from Tom Fox.

That brings us to the close of this week’s PC News Week in Review. August may be a big “vaca” month for many of us, but you know what never takes a vacation – compliance (oh yeah, we went there). As August winds down and the hustle and bustle picks back up in September, we can help you re-fresh old training or launch new compliance training on a variety of topics from the FCPA to the PDMA and everything in between.

If you are headed out on holiday yourself, be safe and have a great time! Send us a post card! We’ll be right back here when you return, ready to inform and even entertain you with all the news you missed.

Have a great weekend everyone!