Week in Review, December 3, 2012

The PharmaCertify™ Team

Thanksgiving is behind us and now we move on to other celebrations of the season. As December kicks off, so do the many Christmas parades in towns, cities and theme parks around the country. And who doesn’t love a parade? We can’t wait for the colorful floats, marching bands, and classic cars, while we stand for hours in the cold, breathing in the fumes from the tractors pulling the floats, getting pelted by candy thrown from the floats by overzealous scouts. What’s not to love.

Speaking of causes for celebrations, we begin this week with the big news that the Office of Management and Budget is now in possession of the final rule for the Sunshine Act. CMS says the final rule will be published by the end of the year. (is that the sound of skepticism we hear out there?) Data collection begins January 1, 2013.

The speaker’s bureau parade is coming to an end for faculty at the Oregon Science and Health University. The proposal prohibiting faculty from serving as paid speakers for pharmaceutical companies is expected to be approved in the next couple of months. A petition supporting a ban on participating in speaker’s bureaus was signed by over 100 students at the University earlier in the year. Not everyone is thrilled with the idea. The faculty responsible for the presentations is concerned that the information they share during lectures will be delivered by less qualified physicians.

The OIG has billions of reasons to celebrate this season. In its semi-annual report to Congress, the agency lists expected recoveries totaling $6.9 billion among its accomplishments for the second half of the fiscal year. The OIG identified $8.5 billion in savings for the government, and that they excluded over 3,100 individuals from federal healthcare programs.

The OIG also informed Tennessee that the state’s false claims act needs work. In 2011, the agency notified several states their laws regarding Medicaid false claims were not as stringent as the federal law and they needed to bring the laws up to snuff in order to receive additional recovery money. Tennessee amended its law, but the OIG says the amended law does not offer enough protection for whistleblowers.

On the anti-bribery front, a drilling company located in Scotland became the first company to negotiate a settlement under the UK Bribery Act. The company will pay £5.6 million, the amount of profit gained through the bribes, and will not face further investigation.

In FDA news, the OPDP issued an untitled letter to Cornerstone Therapeutics addressing a pitch letter generated by the company, which allegedly contained false and misleading information and  unsubstantiated superiority claims. It’s rare to see an FDA letter issued against a PR piece, as FDA enforcement tends to focus on non-PR pieces.

That’s all for this News in Review folks. Have a great week and remember, as you map out your 2013 compliance training, PharmaCertify offers the custom, off-the-shelf, and mobile training you need to help ensure your team has the latest in compliance content integrated into their daily work lives.

See you next week!

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