Open Payments Funding and Another Kickback Case in the News

An Open Payments letter from two senators, a list of diabetes drugs from Nevada, near silence from the Office of Prescription Drug and Promotion (OPDP), and an unsealed kickback case…all in this edition of the Compliance News in Review.

Thanksgiving is just around the corner! There’s nothing like a day of food, family, friends, and parades (and of course, football!) to kick off the holiday season. Can’t you just smell the turkey and fixings permeating the hallways and your olfactory senses now? Before we go unpack our “Thanksgiving pants,” we’ll leave you with a different type of tasty morsel: a new edition of the Compliance News in Review. Bon appetit!

Senators Richard Blumenthal and Chuck Grassley don’t want to see CMS’s Center for Program Integrity (CPI) left at the kids’ table. They sent a letter to the acting Health and Human Services Secretary urging that funding for the CPI be made a priority. The CPI is responsible for managing the Open Payments database. The letter includes references to “recent reports that have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic.”

Nevada’s Department of Health and Human Services published its list of three dozen diabetes drugs that are subject to the State’s new transparency law. Manufacturers with a drug on the list will have to report a variety of financial information, including costs associated with production the drug; rebates and coups offered; and profits earned from the drug. Regulations for reporting the information are still pending.

Will the OPDP pass on dessert at Thanksgiving Dinner? OPDP is on pace to issue a record low number of letters this year. So far, only two letters have been issued. In 2016, the agency issued five in the first six months, then in December, it issued six more. The letter count has steadily declined over the last sixteen years. Will 2017 will be a record low?

On the social media front, Twitter upped its character limit to 280, and according to social media manager, Andrew Grojean, pharmaceutical marketers should take advantage of the expanded word count. Grojean says the change does not solve all the issues related to use of the platform, but it provides more freedom and flexibility, as well as more space for the required fair balance.

Did Eli Lilly over stuff the turkey? A recently unsealed whistle blower case alleges that the company provided kickbacks to boost sales of its drugs. According to the suit, the company offered nursing services to HCPs through a third-party to induce doctors to prescribe three of its drugs. Allegedly, the nurses essentially acted as sales reps even though they were supposed to be providing independent medical advice and disease state education.

With that, we end this holiday edition of the Compliance News in Review. In the spirit of the season, we are thankful to all who take the time to read our tome on a regular basis, and as always, we invite you to contact our editor, Sean Murphy, with your feedback. He can be reached at smurphy@nxlevelsolutions.com.

Have a fun and festive Thanksgiving holiday!

Compliance Buzz™ February 29, 2016: Three observations from OPDP Notice of Violation Letters

Welcome to the first issue of PharmaCertify Compliance Buzz™!

From Corporate Integrity Agreements to FDA guidance documents, the material published by government enforcement entities offers valuable insight into the enforcement of healthcare laws and regulations. This holds true for Notice of Violation (NOV) and Warning letters issued by the FDA’s Office of Prescription Drug Marketing (OPDP). Regularly reviewing these letters as they are released is one way to ensure training about compliant product promotion is up-to-date and relevant.

So for this inaugural edition of Compliance Buzz™, we have reviewed the NOV and Warning letters OPDP issued over the last several years, and identified three trends to keep top of mind as you evaluate your compliance training program.

Focus on smaller companies. In recent years, the focus of OPDP letters has been small and medium-sized companies, rather than larger companies. In 2015, only three of the ten letters were issued to companies listed in the Scrip100 top 50 pharmaceutical companies. In 2014, only one letter was issued to a top 50 company, and in 2013, only five. Compare this to 2010, when 2/3 of the letters were to top 50 companies. While this doesn’t necessarily mean that OPDP is targeting smaller companies, it is a compelling trend to keep in mind, especially if your company falls into the small to medium-sized category.

Rise of Social Media. The OPDP is taking note of the industry’s Internet presence. Almost half the letters issued in 2014 and 2015 involved promotional information found on the Net, including posts on Facebook, Instagram, and Google Ads. The only letter issued thus far this year involves a YouTube post. The information required for promotional material doesn’t always align with the untamed spirit of social media, and it’s easy to assume that using links or other shortcuts to the required information is sufficient. As we all know, it’s not. As the industry continues to embrace social media as a promotional tool, training programs need to include content regarding the use of these platforms.

No risk, no reward. Omission of risk is one of the most often cited issues in letters sent by the OPDP over the last couple of years. Discussing the negative aspects of a product is not always comfortable for those responsible for promoting a product. However, for the pharmaceutical industry, it’s a requirement. Disclosure of product risks and benefits is a critical topic for training.

While the ODPD has issued significantly fewer letters in the last several years, there’s still much to be gleaned from the comments found in those letters. They are valuable touchstones for evaluating the content of your compliance training and offer important real-word examples to share with your learners.

Thanks for reading and stay compliant!