2013 Year in Review

With a blink of an eye, 2013 comes to an end. Didn’t it just start? As the dust settles on another year and we pack away the party hats and noisemakers, we pause to look back at some of the big stories that shaped the world of life sciences compliance over the last year, with our second annual Year in Review.

The big story of the year was transparency, transparency, and transparency. After closing 2012 with the draft of the final rule for the Sunshine Act (now known as Open Payments), CMS fielded comments from various stakeholders, and in February the final rule was released. Data collection began on August 1 and report templates, FAQs, and webinars followed throughout the year.

The stakeholders involved didn’t hesitate to weigh in about the rule. For example, the AMA (along with other physician groups) wrote to HHS, saying the value of journal reprints and text should not be reportable because items like these benefit patient care. Payments related to CME events are still a bit blurry and the process for handling payments related to unaccredited CME also remains a hot button issue.

Transparency in the financial relationships between physicians and the industry wasn’t just a U.S. story, it was global. In May, France issued the final decree on its law requiring the disclosure of payments to physicians. The requirements of the law are similar to those of the Sunshine Act, and payment reports are made public on a website.

Several industry groups around the world announced payment transparency initiatives. Medicines Australia added transparency requirements similar to the Sunshine Act to its Code of Conduct. Medicine Australia’s Transparency Working Group has been working on the requirements, and the current edition of the Code is under review until the middle of 2014. Upon approval, the Code of Conduct will go into effect in January 2015.

The Association of the British Pharmaceutical Industry (APBI) announced it would require member companies to provide information on payments made to physicians. The organization is changing its Code of Practice to include the transparency requirements, and the changes should be in the 2015 Code.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) amended its Code to include a requirement that member associations implement payment transparency requirements by 2015. In addition, the EFPIA and PhRMA joined together to release principles on clinical trial data transparency. The principles provide for the release of patient level and full study data to qualified researchers.

Enforcement of anti-corruption laws has been a hot topic in recent years; most notably the DOJ’s and SEC’s stepped-up enforcement of the FCPA and the passage of the UK Bribery Act. In 2013, China clamped down on bribery and began enforcement of its own laws, with a bulls-eye on the pharmaceutical industry. Starting with the detainment of several GSK executives in China, reports emerged regularly of investigations into pharmaceutical companies for alleged bribes paid to doctors and hospitals.

In recent years, the federal courts handed the industry significant “victories” in decisions regarding the Vermont data mining law and the Caronia case. This year, the U.S. Supreme Court ruled against the industry and sided with the Federal Trade Commission when it decided that pay for delay deals violated antitrust laws. While the decision does not make the deals illegal, it does open the door for lawsuits to be filed by wholesalers, distributors and enforcement agencies.

We end our review of 2013 with a story that could very well shape the dialogue in 2014. In the last weeks of 2013, GSK announced it would no longer pay doctors to promote its drugs or to attend medical conferences. The company will continue to pay for advisory and consulting services. GSK also announced a global expansion of the program by which sales reps are compensated on parameters other than the number of scripts written. The program is already in place in the U.S.

And with that, we close our look back on the big stories of 2013. This year promises to be as eventful, particularly with the first Sunshine-related reports due and the eagerly-awaited social media guidance scheduled for release by the FDA. Through it all and throughout the year, we’ll be here to keep you up-to-date on all the compliance news you need to know.

Happy New Year everyone!

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s