Week in Review, September 30, 2014

PhRMA and the DOJ argue the details of the Integrilin case, sentences and a fine are handed down in the GSK Chinese bribery case, more elected officials weigh in on the removal of the CME exclusion from the Sunshine final rule, and the OIG raises concerns over drug coupons and the potential for kickbacks.

The cosmos (and Starbucks – welcome back Pumpkin Spice latte) say fall is officially upon us! Cooler weather is on the way, and so is pumpkin picking and that extra hour of sleep. Time to gather around the fire pit and scarf down a few S’mores! But before we lose ourselves in a soliloquy about the magical mysteries of a great corn maze, we’ll navigate the twists and turns of this week’s News Week in Review.

There’s a certain chill in the air between PhRMA and the DOJ. A few weeks back, we highlighted the story about PhRMA filing a “friend of the court” brief in a whistleblower case involving the off-label promotion of the heart drug, Integrilin. The brief presented the claim that the whistleblower’s arguments raised free speech issues and the organization asked the court to reject the whistleblower’s claims . In a response, the DOJ said PhRMA’s brief did not establish a First Amendment violation. In fact, according to the agency, no precedent existed to support PhRMA’s argument that the False Claims Act could not have been implicated. PhRMA shot back, saying for a person’s speech to knowingly cause a false claim to be submitted there has to be a “direct causal nexus between the speech and the claim” and sharing peer reviewed journals with truthful information about an off-label use does not meet this requirement according.

The summer has ended, and so has the GSK Chinese bribery scandal, with a court levying a $500 million dollar fine against the company. The country manager for GSK and four other executives were found guilty and faced prison terms of up to four years. The Chinese court suspended the sentences, and declared that the country manager, a British national, could be deported. According to the court, all of the country manager and executives pled guilty and had no plans to appeal the verdict. The fine imposed on GSK is the highest fine the Chinese government has ever imposed in a bribery case.

On the Sunshine front, U.S. Representatives Michael Burgess and Frank Pallone sent a letter to CMS expressing concern over the removal of the CME exclusion from the final rule. The two representatives say the current rule provides a clear exemption for payments and transfers of value related to CME, while the proposed changes are ambiguous. Burgess and Pallone ask CMS to carefully consider the comments they have received from stakeholders about the proposed change. Representative Burgess also teamed up with Representative Allyson Schwartz to introduce legislation to exempt textbooks, indirect CME payments and journal articles from the Sunshine Act’s reporting requirements.

Industry trade groups are bobbing for an explanation, again, as to why nearly one-third of data submitted to Open Payment was removed from the system. PhRMA, AdvaMed, and BIO sent a letter to CMS reiterating concerns that the agency still had not provided an explanation as to what happened to the data. The groups are hopeful that the issue can be resolved quickly, so the public can be confident in the accuracy of the data.

According to a report from the OIG, the use of drug coupons could lead to kickback violations. The OIG investigated the use of coupons to purchase drugs covered by Medicare. Nearly 7% of senior citizens reported using coupons to purchase drugs covered by Medicare Part D. Coupons cannot be used to purchase items covered by Medicare Part D and inducing consumers to do so can be considered a kickback. The agency found inconsistencies in how drug companies implemented safeguards on their coupons. Printed coupons tended to have language advising consumers the coupons could not be used for Part D purchases, but only 80% of web coupons included the same language. In addition, nearly one-third of manufacturers surveyed did not include eligibility information for the pharmacists. The OIG recommends CMS work with drug makers to improve the process of identifying patient enrollment in Medicare Part D, and to improve the reliability of pharmacy claims.

FDA’s social media guidance left PhRMA feeling a little chilly. In comments submitted to the FDA, the organization expressed concern that the guidance discourages manufacturers from sharing meaningful information with patients on social media networks. According to the comments, the guidance, as written, places undue responsibility on the manufacturers for what users say about the products.

With that, we close out the post autumnal equinox edition of the Compliance Week in Review. Have a great week everyone and enjoy the colors of fall!

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