Week in Review, Easter Bonnet Edition

The PharmaCertify Team™

File this one in the “time flies, doesn’t it category,” but here we are already at the end of March, 2013. While we’re surrounded with the usual offerings of the NCAA tournament and spring-like weather (okay, maybe that wasn’t funny considering winter has yet to release most of the country from its cruel grip), this year, the end of March signals diversions much more significant than the usual planning of the perfect April Fools prank. Easter arrives early! Now is the time to map out the course for the annual massive Easter egg hunt and undo all of that post New Year’s weight loss with preparations for a holiday feast. As we look forward to the festivities, we begin with tasty appetizer we call the News Week in Review.

The first story hopping into the Review involves a push for a national system to track off-label drug use in Canada. Dr. Robyn Tamblyn, a researcher and scientific director with the Canadian Institutes of Health says the issue of off-label drug use needs more study. According to a study, just over 10 percent of prescriptions written in Canada are for off-label use, and the majority of those are issued without sufficient evidence to support the physician’s decision to prescribe off-label. Dr. Tamblyn proposes the idea of a national tracking system. The system would use the existing electronic prescription infrastructure, and would require physicians to note if a drug is being prescribed for off-label use and why.

The seal on a whistleblower case against Cephalon was lifted last week, revealing allegations of schemes to market a leukemia drug and pain drug off-label, even while the company was under a CIA. According to the suit, executives knowingly engaged in the off-label marketing plan. Alleged tactics included; paying doctors to attend programs where off-label use was discussed; paying higher than normal fees to group purchasing organizations who encouraged doctors to write off-label for the drugs; and transferring $2 million from the sales and marketing budget to the medical and scientific affairs budget in order to fund CME programs. In addition, after a sales audit showed widespread off-label promotion by sales reps, the head of global compliance told sales reps the audit was designed to not break down data at a rep level, so individual reps would not have to be fired. The federal government declined to join the whistleblower suit.

The OIG added more requirements to the basket for state false claims acts. State false claims acts that meet certain requirements can receive an extra 10% in Medicaid recoveries. The changes made by the OIG are intended to incorporate amendments to the False Claims Act brought by the Frank-Dodd Act, the Affordable Care Act and Fraud Enforcement and Recovery Act. In other OIG news, HHS Inspector General, Daniel Levinson, testified before a sub-committee of House’s Committee for Appropriations on the top management challenges faced by his office. Mr. Levinson cited the effective administration of grants and contracts, protection of security and integrity of data, systems and technology, and reduction of the reporting of improper payments as some of the top issues.

The U.S. Senate is expected to pass a resolution to repeal the medical device tax. The resolution will not actually repeal the tax though because it is attached to a non-binding amendment to a non-binding budget measure.

The debate over transparency in the relationship between the pharmaceutical and medical device industries and physicians continues. A recent article in Forbes highlighted the potential for misinterpretation of the data found in Pro Publica’s Dollars for Docs database. While the data does provide insight into who got paid what by whom, it does not provide the necessary context around the payments. For example, a speaking payment could reflect one engagement or twenty, and travel-related payments may cover a trip to an expensive resort for a conference or the cost of travel for a bona fide outreach program.

The final eggs in our basket are from Daniel Garen, Vice President and Chief Compliance Officer at Wright Medical Technology. Mr. Garen opened the 2013 Pharma Forum in Orlando with a presentation focused on what meeting managers need to know about the Sunshine Act. He emphasized that data on payments already exists and is currently being mined by federal enforcement agencies.

Have a great week everyone and enjoy the holiday!

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