The PharmaCertify™ Team

Did you enjoy this holiday week? Holiday? Yes, it was Flag Day here in the U.S.! We hope you were able to celebrate by waving the Red, White and Blue and maybe lighting up a sparkler or two. (ONLY if fireworks are legal in your state that is. We are all about compliance after all!) With celebrations all over, it is time to greet the weekend and this week’s edition of the PC News Week in Review.

A subcommittee of the House Judiciary Committee spent Flag Day holding a hearing about everyone’s favorite anti-bribery law, the FCPA. The DOJ defended its stepped up enforcement efforts. Citing an estimate from the World Bank, the DOJ said bribery is a huge problem, and that changes in the law could signal the U.S. isn’t committed to prosecuting bribery cases. Panel chair, Rep. James Sensenbrenner, said that changes were needed in the law. He said the enforcement was “vague and impenetrable”, and lawmakers were currently drafting a bill to clarify the law. Rep. Robert Scott questioned if the law in its current state coupled with aggressive enforcement efforts could be hindering business development overseas. Lobbyists from the U.S. Chamber of Commerce are seeking six changes in the law. At the top of the list is the addition of a compliance defense similar to that in the U.K.’s anti-bribery law.

An article in the Miami Herald unfurls the off-label marketing practices of a pharmaceutical manufacturer. Documents in the recently unsealed case contained dozens of internal company documents and emails which allegedly reveal how doctors were convinced to prescribe for off-label uses. One of the whistleblowers, a former sales manager, said off-label sales were very important for one of the products involved in the suit. Documents showed the company targeted physicians that would be easily influenced, paid as much as $1,000 for preceptorships, and held dine-and-dash programs.

In Massachusetts, a new piece of legislation was run up the flag pole regarding the state’s gift ban and disclosure law. Several months ago, legislation was introduced in the MA House to repeal the law. While that is being debated in committee, legislation was introduced in the MA State Senate to get rid of the part of the law that bans meals outside of the physician’s office or a hospital setting. Restaurant representatives appealed to senators to pass the bill in support of small businesses. Restaurateurs say the current law is hurting their business in an already difficult economic climate. Those opposed to the repeal doubt that the law has hurt the restaurant business. Those who support the law in its current form say it is needed to protect the doctor-patient relationship from undue influence of industry, and to help control healthcare costs.

In Massachusetts’s neighbor to the north, Vermont, the Attorney General’s office held a conference call this week to discuss the new guidance for the state’s gift ban and disclosure law, and PC staff sat in on the call. Good points for clarifying the mergers and acquisitions section of the guidance were presented during the call. There was also much discussion around guidance of when products given to healthcare professionals should be reported on the samples report versus the regular report. The office said it would probably have to go back to the legislature regarding how reporting of donations to national patient advocacy groups were made. As the call wrapped up the AG’s office said enforcement efforts were on the way, and advised everyone that they published all settlements on their website. No ETA was given as to when the final guidance would be published. (The current draft guidance can be found here.)

Waving the white flag? We don’t think so! The Digital Health Coalition, a non-profit group, has been formed to discuss how to move forward with digital marketing and social media for the industry. The group has representatives from pharmaceutical companies, digital health companies as well as Google. The group’s position is that it is the industry’s responsibility to determine the best way to responsibly market products through digital media, and has every intention of working with DDMAC to develop a solution.

Several good stories and a few bad flag references later, it’s time to wrap up this week’s news review. But before we do, a big congratulations to Michael Shaw of GlaxoSmithKline. He was named America’s Funniest Compliance Officer! The event was held at NYC’s Comic Strip and raised money for juvenile diabetes research. Kudos to Mr. Shaw for finding the funny in “Risk. Problem. Solution.”  Not the usual fodder for comedians. We can only hope to see the act reprised at this year’s PCF. (hint, hint).

Well that’s all for this week (really…this time it is). Whether you need new training or need to refresh your current training on compliance topics such as FCPA or on-label promotion, we can help with our customizable, off-the-shelf solutions. Check us out at www.pharmacertify.com. Have a great weekend, and happy Father’s Day to all you dads out there!