The PharmaCertify™ Team

Is it the end of March already?! This first quarter of the year has flown by hasn’t it? Well with the end of March also comes the end of March Madness. The final games in the NCAA basketball tournament will be played this weekend in the Big Easy. How have your brackets held up? If they haven’t done well, you can always take your chances with the $500+ million Mega Ball drawing this weekend. Okay, time to put the dreams of scoring big aside, and get back to the real world; this week’s News Week in Review.

The Massachusetts Restaurant Association is hoping a new bill in the Massachusetts legislature will get them back in the game of hosting meals between pharma companies and physicians. Massachusetts legislature’s small business and community development committee signed off on a bill which would allow meals to be provided to physicians in restaurants. The Massachusetts House of Representatives has been supportive of such measures in the past, but the Senate has been more resistant. The CEO of the restaurant organization says restaurants are suffering due to the ban, and he hopes legislators will see the job creation benefits of passing the bill.

Seems the drug sample possession arrow is pointing toward pharmaceutical companies rather than doctors’ offices. The number of samples left by sales reps is down 25% since 2007. The reduction is largely due to the cut back in the sales force numbers and the fact that many offices are refusing to take samples. According to a survey, 23% of physicians’ offices do not accept drug samples.

The OIG and forty-two industry compliance professionals met at center court in February to discuss a number of compliance issues facing the pharmaceutical industry. Industry attendees at the meeting were all from companies currently under a CIA, and as you might imagine a top topic was the challenge in implementing CIAs. Other topics on the agenda included: compliance program structure and oversight; risk assessment and monitoring activities; policies, procedures and training activities; and compliance post-CIA. As the meeting wrapped up, industry participants noted a number of changes which would pose challenges for the future such as regulatory changes (ex. Sunshine Act), social media and lack of regulatory guidance in that area, and a changing business model in the industry.

Speaking of social media, the industry may essentially be on the sidelines when it comes to participating in social media, but a recent survey suggests companies are getting into the game of using social media for market research. Survey respondents predicted their companies would be using social media for market research in the coming year. At the Pharmaceutical Marketing Research Group National Convention, companies already engaged in this practice said listening to patients through social media outlets helped them shape clinical trials and product messaging. In addition, this type of research can have an advantage over more traditional market research methods in that companies have more than one shot at gaining patient feedback.

Just when we all thought the final buzzer had sounded on the FCPA sting case, more news emerged this week. Government prosecutors petitioned the court to have the convictions dismissed of three of the defendants who previously pleaded guilty to conspiracy charges in the case. Charges were dismissed against 16 other defendants still facing prosecution when the government decided not to proceed further with the case. The dismissal did not apply to the three defendants who had already pled guilty. The government said the dismissal of charges should also apply to these three defendants.

On the settlement front, Biomet Inc. entered into a Deferred Prosecution Agreement with the DOJ to resolve charges of improper payments under the FCPA. The company will pay $17.8 million in criminal penalties, and in agreement with the SEC, another $5.4 million in disgorgement of profits. Cypress Pharmaceuticals, its subsidiary Hawthorn Pharmaceuticals, and its CEO have agreed to pay $2.8 million to resolve allegations the company violated the False Claims Act. The government alleged the company promoted several products that had not been designated “safe and effective” by the FDA. The company promoted the drugs in this manner to physicians which  resulted in improper payments by state Medicaid programs and the military’s TRICARE program.

Well the game clock is dwindling down, and the weekend buzzer is about to sound. We hope yours is full of fun and excitement. If your plans involve watching the NCAA Tournament, consider a chocolate bunny as your game time snack. Apparently chocolate is good for the metabolism among other things. Now that, is truly news you can use!

Have a good one everyone!