Compliance News in Review, August 19, 2016

The Pfizer shareholder suit settlement, Open Payments Open Forum, Robert Callif addresses sharing truthful off-label information, a whistleblower suit, and it’s always Sunshiney in Germany in this edition of the Compliance News in Review.

Dum, dum, da, dum, dum, dum, dum. Dum dum da dum dum dum dum da dum dum dum dum. No doubt you recognized that familiar melody as “Bugler’s Dream” (a.k.a., the Olympic theme). The games in Rio are in full effect! If you’re like us, you’re suffering from sleep deprivation from all the hours of late night coverage. Fear not, we haven’t completely forgone compliance news in favor of sport. Take your mark, because we’re about to start this edition of the Compliance News in Review.

Pfizer is setting aside $486 million in “gold medals” to resolve the shareholder suit over concealing the safety risks of Bextra and Celebrex. The settlement is pending approval of the shareholders, and if approved, will end 11 years of litigation.

Open Payments is back on the track and poised for changes. In July, CMS posed several questions in the proposed 2017 Physician Fee schedule. The agency held an Open Door Forum for Open Payment stakeholders to provide responses to these questions. Much of the discussion focused on the reporting and reviewing of information related to teaching hospitals and whether to increase the number of payment categories. Other topics included pre-vetting data; the review and dispute process; and whether user accounts for physicians can be structured so they don’t expire after six months of inactivity.

A whistleblower claims Celgene isn’t playing the game fairly. A suit filed by a former company sales rep claims the company made donations in order to drive product sales. The suit claims the company made donations and then worked with the charities to assure that the majority of the funds were directed to patients who were using Celgene drugs. Celgene says the claims are baseless and the federal rules regarding donations were followed.

FDA chief Robert Califf spent time hurdling the issue of sharing of truthful off-label information at the recent BIO conference. In his remarks, Mr. Califf said scientifically supported information worth sharing should be on the product’s label, and that there is a responsibility to share use information gleaned through the clinical trial process and it’s reasonable to expect that information to be part of the product’s label. He noted that publicly available information that is not part of the label is trickier, and that the agency was “working on it.”

The score from the German judge is…575 million. According to the German news magazine Spiegel, payments made to German HCPs and HCOs totaled 575 million euro in 2015. The country made the data public in a searchable database following a suggestion by EFPIA. The magazine noted problems with the data being incomplete and inaccurate, and only 75% of pharmaceutical companies were represented. It called for the German government to consider legislation similar to the Sunshine Act in order to implement true transparency.

Well, we need to get back to the thousands of hours of streaming coverage – bring on the table tennis – so we’ll end this edition of the Compliance News in Review here. Enjoy the rest of the Games everyone, and stay compliant.

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