West Virginia repeals its disclosure law, Connecticut modifies its requirements for insurance coverage related to off-label use, two whistleblowers file a suit against Teva, and tighter transparency rules are debated in New Zealand.
Spring has sprung! Woo hoo! Since a number of us “enjoyed” up to 5 inches of snow on the first day official of spring, a break from the drudgery of the bitter temperatures is well-deserved, nay, warranted. The compliance news doesn’t take a break though, so for now, we’ll put our visions of sand castles and sea gulls to the side and focus on all the news fit for blogging, with this week’s Compliance News in Review.
It seems there’s no vacation when it comes to state transparency laws. The governor of West Virginia has approved a bill that will repeal the State’s requirement for pharma companies to report drug advertising and promotion expenses. Expenditures for 2014 are due in April, but the repeal will end the reporting requirement from January 1, 2015 forward. The GOHELP organization has not publicly published advertising expenditures reports since 2010.
Consumers in Connecticut could be getting a break when obtaining medications for off-label uses. A modification to the state’s current law will increase insurance coverage of drugs prescribed for off-label uses. The current law requires off-label coverage if the drug appears in one of three specific medical compendia. Unfortunately, two of the references are no longer published. The revision to the law would require coverage if significant information in peer-reviewed publications support the off-label use.
BioChemics was ordered to pay over $17 million to settle investor fraud charges brought by the SEC. The SEC says the company lied to investors about its research, FDA communications, and status of clinical trials, and provided false valuations for the company. The company collected over $9M from 70 investors. The judgement supplements another judgement against the company’s founder and two promoters from earlier in the month.
Party crashers? A new survey shows securities fraud class action suits against life sciences companies are on the rise. In 2013, there were 19 suits against life science companies. In 2014 that number rose to 39, and represented 23% of all securities fraud cases for the year. Most of the defendants were smaller companies.
Green is the color of spring, and apparently the color of honorarium envelopes at Teva, according to two former sales reps. A whistleblower suit filed against the company claims that Teva engaged in sham consulting arrangements in order to boost prescriptions of Copaxone and Azilect. The two claim that doctors were only allowed to remain speakers for the company if they increased the number of prescriptions written for covered drugs, and that the content of the programs had very little educational value.
The “sunshine” is shining bright in New Zealand, even though they are celebrating the fall season there. In a recent New Zealand Medical Journal article, transparency advocates made an appeal for a U.S. style Sunshine Act. The authors argue that while disclosure requirements are being tightened in other countries, the situation remains “murky” in New Zealand, where doctors receive remuneration for a variety of services, and sponsorship for accommodations and travel to conferences. One of the authors has spoken out about the topic in the past, and has been critical of Medicines New Zealand for its lack of transparency regarding the disclosure of physician payments. While not outright dismissing the idea, Medicines New Zealand has stated that adding disclosure requirements would be complex and require a significant amount of resources.
With that, we close out this spring season edition of the Compliance News in Review. Speaking of sunshine, as transparency requirements grow around the world, the PharmaCertify suite of training solutions offers your learners the content they need to navigate the cloudy world of pharmaceutical compliance reporting regulations.
Have a great week everyone!