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!

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