The universe has spoken – summer is officially here. (If you’re living in a part of the country that is in the midst of a heatwave, I’m sure you’re thinking “never mind what the calendar says, summer has been here for two weeks!”) Now that we’ve crossed the solstice for another year, let’s take a look back at how spring ended, in this issue of the Compliance News in Review.
PetroTiger escaped the heat of an FCPA prosecution. In a highly unusual move, the DOJ announced it would not charge the oil company with violating the FCPA. Three company executives have already pled guilty to the same charges, and typically charges against the company follow. In this case, the DOJ decided otherwise, saying PetroTiger had fully cooperated with the investigation.
The Sunshine Act is never far from the minds of physicians, no matter the season. 100 physician organizations sent a letter to Representatives Richard Michael Burgess and Peter DeFazio expressing support for a bill that would exempt payments for CME and educational materials from the Sunshine Act. The Representatives introduced the bill in an effort to correct the “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain.” The physician groups claim that the dissemination of medical education materials has already slowed as a result of the law.
The sun has set on an off-label marketing case for a former Merck company. The company settled with the government for $5.9 million in an illegal marketing case involving its former Inspire Pharmaceuticals unit. According to prosecutors, Inspire claimed its pink eye drug was effective for treating blepharitis, a condition for which the drug was not approved. According to the government, the promotion of the drug for the off-label use led to false claims being paid by government healthcare programs. Merck claims the activity occurred before it acquired the company. Inspire was sold to Akorn in 2013.
FDA officials shed some light on advertising and promotion enforcement at the 2015 Develop Innovate Advance conference. Deborah Wolf of the Division of Premarketing and Labeling Compliance discussed several promotional issues surrounding devices, including the risk of physicians promoting devices for unapproved uses.
Tom Abrams of the Office of Prescription Drug Promotion said the most common areas of enforcement for his office involved unsubstantiated superiority claims; overstatement of efficacy; and omission and minimization of risk information. Lisa Stockbridge of the CEBR’s Advertising and Labeling branch said that biologics faced many of the same issues as prescription drugs. She referenced an untitled letter sent to a company for claims made by the company’s CEO in a video interview posted on the company website, which included unsubstantiated claims about one of its products.
Obviously, product promotion remains a hot topic, and with good reason. As we continue to see in the news, off-label promotion violates the FDCA and implicates the False Claims Act, and can result in pretty hefty penalties. However, training needs to go beyond on-label promotion, and cover the topics referenced in the stories above. Misleading statements, false efficacy claims, and omission of risk lead to untitled letters from the FDA, and as seen in the 2014 Shire case, can be used by the DOJ in cases against manufacturers.
All facets of promotional speech need to be covered in your compliance training, especially since the FDA has essentially deputized healthcare professionals to be on the lookout for promotional speech missteps through their Bad Ad program. More and more eyes are focused on product promotion, so making sure everyone responsible for making promotional statements, in any form, is aware of the requirements, is more critical than ever.
That’s the news for this edition. Stay cool and have a great week everyone!