Compliance News in Review, February 1, 2016

It’s Super Bowl week! Another season of ups, downs, highlights, lowlights, hope, and unfulfilled expectations for fans around the country (except for those lucky enough to root for the winning squad) is about to end. Now we’re left to fill a long seven month void until training camp begins anew and hope springs eternal (we know, we’ve mixed our sporting metaphors). Whether you’re pulling for the Broncos or the Panthers, or just a strong lineup of new commercials (spoiler alert), the day is bound to deliver cheers, groans, and snacks aplenty. Before you dive into the game preparations, we offer a playbook of our own, with this edition of the Compliance News in Review.

We kickoff this edition with news from the expanding world of federal oversight. The DOJ announced that it is adding some muscle to the huddle, and bolstering its anti-corruption resources, by hiring ten new prosecutors for its FCPA unit.

It’s time for a regulatory end zone dance in Kentucky. State Attorney General, Jack Conway, has entered into settlements with Endo and Johnson & Johnson over accusations related to the companies’ marketing practices. The state settled with Endo for $24 million over its marketing of OxyContin. The suit accuses the company of positioning the drug as “non-addictive” and encouraging reps to tell doctors it was less likely to be abused than other opioid drugs. The settlement will be used to fund addiction treatment programs. The state settled with Johnson & Johnson for $15.5 million over the marketing of Risperdal for unapproved uses.

The physician leading the charge for a Sunshine Act in Scotland says the public consultation on his petition to Parliament is “unbalanced.” Dr. Gordon, a former National Health Service psychiatrist, says that Parliament is not presenting full information about the current status of the disclosure of payments from life sciences companies to NHS workers. He says information being presented to the public implies that current disclosure rules may be working and sufficient. The doctor claims the evidence presented in his petition shows that payments are escaping current disclosure requirements. Twelve public discussion groups have been held to discuss the matter and more will be scheduled.

The news on the Final Rule is finally off the bench! At long last, the Average Manufacturer Price (AMP) Final Rule has been released. Included in the new rule is language now excluding sales to 340B covered entities from AMP and Best Price (BP); and revised language regarding the exclusion of patient coupons, vouchers and free goods from AMP and BP. In other news from CMS, the Open Payments system is now ready to begin accepting registration, recertification of registration, and data submissions from applicable manufacturers and GPOs. Data submissions for the 2015 calendar year are due March 31st.

Has the ruling on off-label promotion been reversed upon further review? In proposed jury instructions at the trial of a medical device company and its chief executive, the DOJ indicated that it is “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.” Does this change the off-label playing field?

Before choreographing an end zone dance of our own over the last bit of news, we have to think about what it really means and whether anything really changes. For trainers, probably not. Even if the government is ever so slightly agreeing that truthful off-label speech is lawful, the fact remains, untruthful off-label speech is illegal. Therefore, now is not the time to abandon or diminish on-label training. Your training must still cover the illegal nature of off-label speech, and the proper handling of off-label inquiries. The importance of vetting promotional statements before they are shared with HCPs or the public must still be stressed.

Well, that’s a wrap for this edition of the Compliance News in Review. If you have a side in the big game, good luck!

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