The PharmaCertify™ Team

Ah, a short work week. Thank you Labor Day! However, this September day is bittersweet as we bid the carefree days of summer and wearing white shoes good-bye for fall. As the weather turns cooler we do have the turning of the leaves and all the great fall activities to look forward to, so it isn’t all bad, right? As we look forward to the fall and all it brings, let’s take a look back at the week that was in the PC News.

Pro Publica has updated its Docs for Dollars database. According to their analysis, $220 million was paid by pharmaceutical companies to doctors for meals, travel, speaking fees, and other services. Then like leaves in the fall, local news stories began drifting down. In Massachusetts, payments to doctors actually fell. Oregon doctors received $5.8 million from Pharma companies and in Tennessee that number was $20.8 million.

The lack of fair balance in ads for products cross promoted on Liptor.com left DDMAC feeling a little cool and resulted in an untitled letter being issued to the drug’s maker. The complaint, which came through DDMAC’s Bad Ad program, dealt with the “online resources” section of the website which cross-promoted three other drugs as “Medicines that may treat Heart Disease Risk Factors.” Links to the drugs’ websites were provided, but DDMAC did not feel that did enough to address the risks associated with drugs.

The U.S. has joined in a False Claims Act whistleblower suit against Par Pharmaceuticals. The suit alleges the company conspired with pharmacies to switch prescriptions for a generic acid reflux drug from the cheaper tablet form to the more expensive capsule form to get around Medicaid price limits.

Across the pond, the first person to take the fall under the U.K. Bribery Act is a magistrate court employee. The individual is accused of soliciting £500 in exchange for influencing the direction of criminal proceedings against a person charged with a motoring offense. Interestingly the charges were not brought by the Serious Fraud Office, the lead prosecutorial agency for offenses under the Act, but through the UK Crown Prosecution Service. It is expected the CPS will handle domestic cases.

Also in the Old Country, the European Federation of Pharmaceutical Industry Associations (EFPIA) says it believes virtually all data from clinical trials should be published once a medication has been cleared for marketing. The EFPIA communicated its position in a response to a guidance document on the topic put out by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

According to recent statistics, healthcare fraud prosecutions are doing anything but falling. Analysis by the Transactional Records Access Clearinghouse shows that the number of healthcare fraud prosecutions is on track to increase 85% in 2011.

We’ll wrap up the news with a report from the Office of Civil Rights. The OCR released information that since the implementation of HITECH in 2009 there have been 30,000 reported data breaches affecting nearly 7.9 million individuals. Major breaches, those that affect more than 500 people, represented less than one percent of the total breaches reported. The most common cause of a breach was theft.

This brings us to the end of the PC News in Review, and just a bit closer to the end of the work week. We would be remiss if we did not acknowledge the tenth anniversary of the September 11^th attacks that occurs this weekend. Still today, seeing the images from the day brings back that exact feeling of shock and heartbreak. However, in all the tragedy we were reminded of the bravery of first responders who ran toward the danger to help, and the heroism of everyday Americans who fought back on a plane to save people they didn’t know hundreds of miles away. We saw the immediate outpouring of help from fellow Americans through donations of time and money to help those affected by the tragedy and those working at Ground Zero. So as we go about our weekend let’s all take time to remember those who were lost, and be thankful to live in a country that despite any differences we may have, the citizens become united as one in the face of adversity. God bless America.

Just as summer has dwindled away we find ourselves here at the end of this week’s PC News Week in Review. If your fall plans include a refresh of old or adding new compliance training, we can help. Our off the shelf e-learning modules cover compliance topics from the FCPA to the PDMA for both pharmaceutical and medical device companies. Check us out at www.pharmacertify.com.

Enjoy the weekend!