Compliance News in Review, March 29, 2016

New anti-corruption measures are introduced in Australia, the FDA announces a new requirement for opioid labels, PhRMA is sending researchers to Capitol Hill, and Respironics settles False Claims allegations.

Everything’s coming up roses…and daffodils and tulips. Spring fever is here! Of course, with that beauty comes all that not so lovely pollen, but for now at least, we prefer to stay positive. To help pass the time as you wait for old man winter to release his final desperate grip, we offer the Compliance News in Review, blooming with all the recent compliance fit to blog.

Seeds of change have been planted in Australia. Following criticism from the Organisation for Economic Co-operation and Development, the Australian government is taking steps to strengthen anti-corruption measures in the country. Several new anti-corruption measure have been introduced in the last several months by the government. New laws went into effect that clarified that proving intent to influence a foreign official was not necessary to establish a bribery claim, and that strengthened accounting fraud laws. The government also shared a discussion paper regarding the possibility of implementing DPAs in corporate law cases.

The Food and Drug Administration announced it will now require labels on short-acting opioids to include a “black box” warning about the risk of addiction, abuse, overdose, and death associated with use of the products. The warning must include a statement indicating that the chronic use of the drugs by pregnant women may result in a painful withdrawal process for the newborn. The warning applies to over 200 products. The change comes as part of a larger government strategy to combat opioid abuse.

PhRMA is making plans to sprout up on Capitol Hill. The trade association plans to send top scientists and researchers to meet with lawmakers to discuss drug pricing. PhRMA CEO, Steve Ubl, says the organization is going to take a more proactive tact in addressing issues around drug pricing. Mr. Ubl said, “I think it’s fair to say this represents a bit of a pivot for the organization. We’re going to develop a proactive policy agenda, and we’re going to drive it.” In the past, PhRMA has reacted to negativity about extreme drug price increases at companies like Turing and Valeant, by explaining the complexities of drug pricing, or by distancing itself from the companies by pointing out they are not PhRMA member. Moving forward, the organization plans to push for policy that will limit price increases.

The bloom is off the rose at sleep apnea mask manufacturer, Respironics. The company agreed to pay almost $35 million to settle False Claims Act allegations. Respironics was accused of providing kickbacks, in the form of free call center services, to durable medical equipment (DME) suppliers that bought its sleep apnea mask. DME suppliers that did not use the Respironics product had to pay a monthly fee for using the call center. The illegal activity allegedly occurred between April of 2012 and November of 2015.

Well, that’s all the news springing up around here for this edition. Have a great week everyone and may hope spring eternal!

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