Week in Review, July 1, 2013

The PharmaCertify™ Team

Strike up the band, fire up the barbecue and prepare to proudly fly the flag high! It’s almost Independence Day; the time of year when, despite our differences, Americans come together to celebrate the birth of our nation. But before we find the best spot on the curb to watch the parade pass by, there is still the matter of the work week, albeit a short one. What better way to get us started, than with the News Week in Review.

The US Supreme Court has certainly been busy. In a 5-4 decision, the Court decided that a federal law regarding pharmaceutical promotion pre-empts a person’s ability to file a state suit over a poorly designed generic drug. The case involved a woman who sued Mutual Pharmaceuticals after she suffered an adverse event allegedly caused by one of the company’s generic products.

The British are coming! The British are coming! And they’re serious about anti-bribery. Speaking at an anti-corruption conference, the Serious Fraud Office’s chief investigating officer, Kevin Davis, revealed the organization is actively investigating two cases under the UK Bribery Act. Despite drastic reductions in the SFO’s budget, Davis said cost would not deter the SFO from pursuing bribery cases, and stressed the importance of companies having robust procedures in place to deal with bribery. Davis also discussed the shift in the SFO’s approach to handling bribery cases. He told conference attendees, “We are not an agony aunt or advice service. The SFO had tipped too far towards settlements.”

Medicines Australia took another step toward joining the transparency parade. The agency’s Transparency Working Group released its model for reporting physician payments. The model is similar to the US Sunshine Act, and is currently being reviewed by the larger organization.

John Hancock would be a bit disappointed with recent petition response from the FDA. The agency was petitioned by a non-profit group to increase the type size on DTC ads. The group is concerned that the type is too small for the elderly to read and they are hopeful that a change will reduce accidental overdose and adverse events. The FDA rejected the petition, saying while the concerns are valid, current regulations and two draft guidance policies address the issue satisfactorily. The group was disappointed with the decision, saying that the FDA had turned “its back on millions of patients and consumers nationwide.”

Medtronic declared its independence from an FCPA investigation. In a regulatory filing, the company said it was informed by the SEC and DOJ that the agencies would not be prosecuting the company on FCPA charges. In 2007, the company received letters from both agencies, seeking information on potential violations of the bribery law.

Well, that’s it for this week’s Review. Amidst your plans for the weekend celebration, it’s easy to forget that we are now under the 30 day mark for Sunshine Act data collection to begin. PharmaCertify’s The Sunshine Act: The Federal Physician Spend Disclosure Law covers the reporting requirements and includes practical tips for tracking and reporting crucial spend data.

Have a great week and July 4th celebration!

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