Bring on the turkey, cranberries and uncomfortable family interactions! Thanksgiving is almost here. Soon enough, the stress of all that preparation will melt away as we share meals with friends and family, and depending on how you look at it, a day of crazed shopping the day after will either offer a little more relief or send the stress level right back to record levels. Before your planning kicks into full gear, we offer this small helping of all the compliance news fit to blog, in this edition of the Compliance News in Review. Get it while it’s hot!
The FDA and industry representatives gathered around the table for a two-day public hearing regarding off-label marketing. The agency’s long held opinion remains the same – sharing information about a use that has not been proven safe and effective presents a risk to public health. Industry representatives argued that in a changing healthcare environment, where prescribing decisions are not made exclusively by physicians, the FDA needs to end regulatory barriers and issue clear regulations permitting the sharing of truthful, non-misleading information. The FDA also expressed concerns about the effect that sharing off-label information would have on the industry’s incentive to conduct well-controlled, randomized studies, and that physicians may not have the time to discern what information is misleading.
Former Valeant executives and employees of the specialty pharmacy, Philidor, are being charged with engaging in a kickback scheme to the tune of millions of dollars. According to the FBI, a Valeant executive received $10 million from Philidor. The payments were allegedly laundered through a series of shell companies to avoid detection. In response, Valeant noted that the company itself had not been charged, and documents related to the case made it clear the two former executives attempted to defraud the company.
Teva is setting aside a substantial amount of “leftovers” in the form of $520 million to settle bribery allegations from the DOJ and SEC. The allegations are related to activities in Russia, Mexico and the Ukraine. The company said the allegations did not involve its U.S. business, and implied the issues stemmed from third-parties subsidiaries. Teva also announced that its governance program and processes have since been revamped and it has severed ties with the problematic third-party agents.
Pass the lawsuit, please. A Pennsylvania judge has denied GSK’s motion to dismiss a lawsuit brought by 41 insurers over medications manufactured at a now closed GSK facility in Puerto Rico. The medications were allegedly defective, and the insurers claim GSK induced them to purchase the drugs, and then failed to react when the defective drugs were discovered.
Pharmaceutical sales representatives will now need an invitation from the city to work in Chicago. City Council has passed an ordinance requiring all representatives to obtain a license as part of an effort to help stave off improper opioid prescribing. Reps will have to undergo training on ethics, marketing regulations, and other laws. The fee will be $750, and the license must be renewed annually. The ordinance will go into effect in July 2017. Revenue will be used to educate physicians and patients about opioids.
With that, we close this edition of the Compliance News in Review. Thanks for reading and we wish you and your family a happy and healthy Thanksgiving holiday!