Week in Review, May 4, 2012

The PharmaCertify™ Team

Big news folks! In fact, we’re going to dispense with our usual set up of the News Week in Review, and just get right down to business. We’re sure you will be as shocked as we were when we tell you CMS has pushed back the starting date for collecting physician spend data to January 1, 2013. On the CMS blog, the agency stated that it received over 300 responses during the comment period for the proposed rules for implementation of the Sunshine Act. They also say they would like to give due consideration to the feedback provided during the comment period, and therefore is pushing back the date that data collection is to begin. While not providing a date, the agency says it expects to publish final rules later this year. If we hadn’t bet all our money on Bodemeister to take the Kentucky Derby, we’d be ready to place best on what “later this year” actually means. How about you dear readers? Think we’ll see those rules before Halloween, or will we get another almost Christmas surprise?

Is there anything else worth discussing beyond CMS and the lack of Sunshine regulations? Well actually yes there is. You know how we love a good bribery story, and everyone’s favorite retailer has definitely corned the market in the world of foreign bribery lately. Thomas Fox says the Wal-Mart scandal effectively ends businesses’ push for FCPA reform. The level of the scandal at the company’s Bentonville offices will make the U.S. Chamber of Commerce’s argument for change quite challenging.

On the legal front, Par and the DOJ say they are optimistic a resolution can be reached in the current investigation into the company’s marketing of a drug that treats AIDS-related weight loss. Motions were filed this week asking for a 60-day stay of pending litigation.

There is a good bit of news involving the UK Bribery Act this week. First, the Organization for Economic Cooperation and Development (OECD) issued its review of the Act. The OECD acknowledged that the U.K. had made strides in fighting bribery with the legislation, but the organization does have concerns with several points in the Act. Their concerns include: lack of public information about the settlements, an increase in civil recovery orders (a less transparent process than criminal pleas), and the potential for the SFO to enter into confidentiality agreements, which prevents key information about bribery from being released to the public.

Next we have the results of a survey conducted by Ernst and Young that found only one in four middle managers felt the Bribery Act hurt Britain’s competitiveness. While the results do not paint a completely dire picture of businesses attitude toward the Act, it isn’t completely rosy. Of the respondents that were actually familiar with requirements of the Act, only 30% percent believed Britain’s ability to be competitive would not be harmed by its implementation.

Lawyers specializing in bribery and fraud warn that regulators are stepping up their enforcement of the Bribery Act. New Serious Fraud Office chief, David Green, issued a number of uncompromising messages during his first week in office. In addition, U.K. financial regulators have issued a flurry of guidance about anti-bribery controls. Businesses holding off on putting processes into place until the first big prosecution happens may want to rethink that strategy.

Finally, we take it back to where we started, the Sunshine Act. Michael Loucks and Alexandra Gorman ask the question “who regulates the regulators?” in a blistering opinion piece for Forbes. Loucks and Gorman specifically point to the issue of HHS requiring that payments associated with OTC drugs and Class I medical devices be reported under the Sunshine Act. They claim this is in direct conflict with Congress’ intent for the Sunshine provisions in the healthcare reform law and the requirements will result in higher costs for drug and device manufacturers.

Well gang, we’re off to pick up some mint leaves for the juleps and to grab fixins for some hot browns. Have a great weekend and “may the [horse racing] odds be ever in your favor.”

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