Here’s the tune we’re whistling this week: a California state senator pulls his own proposed transparency bill; an analysis of the FDA user fee programs yields interesting information; former Insys employees in court; FCPA woes at Orthofix International; and a new way for New Jersey residents to learn how much their docs received from the industry.
Summer is coming to a close all too quickly, but you still have a few weeks to cruise the boulevard, roll down the windows and belt out that favorite song at the top of your lungs. Sadly, these anthems tend to disappear at the first hint of cool temperatures, so dance on whilst you can! While you pump up the volume on your music delivery apparatus of choice, we’ll fire up a jam of own, with this edition of the Compliance News in Review.
It’s been a Cruel Summer for a California state legislator. The state senator who proposed a drug pricing transparency bill for the state has pulled the bill from consideration, saying amendments to the bill “made it more difficult for us to accomplish our fundamental goal.”
Could a recent analysis of FDA user fees stir up some Bad Blood? The analysis of FDA user fees showed that the FDA has collected over seven billion dollars in fees since 1992. These fees account for a large percentage, in some cases the majority, of funding for FDA review programs, and there is nearly $300 million dollars in unused user fees being carried by the FDA.
An interactive map shows the Blurred Lines between New Jersey physicians and the pharmaceutical industry. A state news website created an interactive map that provides details of physician and hospital payments from the pharmaceutical industry. Users search by zip code, and see payment details for hospitals and physicians in the area. The site also has an alphabetical listing of physicians and hospitals receiving payments. Data for the site was sourced from the Open Payments website.
Orthofix International allegedly got in the Danger Zone regarding improper payments made by its Brazilian subsidiary. In a recent regulatory filing, Orthofix International registered a charge of $4.6 million to settle potential FCPA charges. The company reported the potential violation to the DOJ and SEC in 2013, and has been cooperating with both agencies to resolve the matter.
If Life is a Highway, a pair of former Insys employees may be about to head down a bumpy road. A former district sales manager and former sales representative recently pleaded not guilty to charges they provided kickbacks to doctors in exchange for prescribing the company’s fentanyl drug. The two are accused of paying speaker fees to doctors for events that were held at upscale Manhattan restaurants and were social, rather than educational, in nature.
With that, it’s time for us to boogie on out of here. We hope to see you back on the dance floor for the next edition of the Compliance News in Review. Until then, stay cool, keep the summertime jams going, and stay compliant.