Industry associations implement new principles on clinical study data, Abbott settles a False Claims case, the SEC suggests that the FCPA could cover commercial bribery, and the FDA wants to know if its messages are being heard on social media.
Welcome to a new year of compliance news! As the calendar turns, our thoughts turn to the yearly rite of passage otherwise known as New Years’ resolutions. Whether your goals are personal in nature (eat right, save more money, exercise more, etc.) or more focused on your professional life, we wish you the best of luck and as we say in the training field, we hope it sticks! At the Compliance News in Review, we resolve to keep you updated every week on the news from the world of life sciences compliance. With that, we welcome you to the inaugural 2014 edition of the News Week in Review.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and PhRMA are starting the year by changing how clinical trial study data is handled. The joint principles on clinical trial data created by the two organizations in 2013 went into effect January 1 and the new principles provide healthcare professionals, qualified researchers and others with the ability to request patient-level data, study-level data, and full clinical study reports and protocols. Some member companies, like GSK and Pfizer, have already provided directions on how to request the data.
Transparency International wants businesses to resolve not to make facilitation payments. In the latest version of the organization’s Business Principles for Countering Bribery, provision of facilitation payments is now considered bribery. Other changes to the principles include the addition of a section addressing conflicts of interest and the addition of a section on the need to complete a business-specific risk assessment when developing an anti-bribery policy.
Abbott is starting the year $5.475 million lighter following a settlement with the DOJ over charges the company violated the False Claims Act. The government alleged Abbott paid doctors to implant several of the company’s vascular products into patients. The suit was originally filed by two former Abbott employees who will receive over one million dollars of the settlement.
The commitment hasn’t quite risen to the level of a resolution yet, but the SEC seems to be indicating it may expand how it enforces the FCPA. At a recent conference, FCPA Unit Chief Kara Brockmeyer told participants that the books and records provision of the Act makes the prosecution of corporate bribery fair game. If corporate bribery is discovered during the course of an investigation, a company’s books and records will be scrutinized and action can be brought against the company.
China is starting 2014 with a renewed focused on bribery involving pharmaceutical, medical device and nutritional products companies. The country is planning to blacklist companies that pay bribes to doctors or healthcare authorities. The first offense will result in a regional ban, and the second in a full country ban.
The FDA is taking new steps to make sure its messages are being heard. The agency will monitor online chatter to see if its social media messages are reaching an audience and if that audience is paying attention.
That’s all for this week folks. Remember, if you’re 2014 compliance training curriculum could use a refresher, the PharmaCertify™ suite of off-the-shelf modules and mobile apps bring up-to-date compliance content on topics like the Sunshine Act and on-label promotion to your staff where they need it most – in the field and at their fingertips.
Have a great week and Happy New Year!