Week In Review, July 8, 2011

The PharmaCertify™ Team

It is the end of an era, as the last space shuttle flight lifted off today at 11:29 EDT. In case you missed the launch, you can check it out here. Awesome sight, no? It’s time to launch into this week’s PC News Week in Review.

Despite a recent ruling to dismiss, a UK businessman says his False Claims lawsuit against Quest Diagnostics is “a go.” The man is accusing Quest of offering reduced pricing to insurance companies in exchange for government business, actions that resulted in inflated laboratory charges to the government to the tune of $1B.

A false claims whistleblower suit has caused the DOJ and several states to launch an investigation into a pain medication management company. The suit filed in a Massachusetts federal court alleges the company encouraged healthcare providers to either bill Medicare and Medicaid for services they did not receive or overbill for the service.

The difficulty of navigating cyberspace for pharma companies makes the news this week. Bayer has issued an apology for tweets that appeared on its UK Twitter feed. The tweets violated advertising regulations set forth by the Prescription Drug Medicines Code of Practice Authority. The primary issues were that the tweets did not appear to have been drafted by lawyers or compliance officers, and they promoted a drug to the public.

In the US, the director of DDMAC says that social media guidelines for the industry are the division’s top priority. Meanwhile, several of pharma’s heavy hitters filed a citizen’s petition with the FDA, requesting clarity around the issue of how to respond to unsolicited requests for off-label information. The petition could delay the release of the planned guidance document on the topic. The document is to include the topic of how to address the requests when they are received over the internet.

To twist a phrase from Jim Lovell – California, we have a problem. A state auditor has urged the governor of California to collect on the $355M in disputed drug rebates the state’s Medicaid program, Medi-Cal, is owed. A PhRMA spokesperson said disputes arise when states submit claims which aren’t in concert with the amount of drugs sent to wholesalers. Also, clerical errors contribute to disputes. The state’s pharmacy benefit chief said these disputes are complicated and take time to resolve. Complicating matters is a shortage of manpower to help resolve the disputes.

Minnesota’s Congressional contingent has joined in the blasting of the FDA for its drop in Investigational Device Exemption approvals. The lack of approvals is blamed for squelching innovation, the rash of new device companies closing or leaving the state and moving overseas. The FDA admits there is room for improvement on their end, however it is quick to point out that there is plenty of blame on the industry side as well. The agency claims companies submit applications with errors and propose poorly designed studies for their devices, which adds to the delay. Ouch. Maybe those involved should listen to the advice of this Minnesotan.

In a recent federal court case, a judge struck down a challenge to a Florida law that prohibits doctors from referring patients for lab work to companies in which they have a financial interest. The group that brought the suit claimed the FL law is pre-empted by the clinical services exemption in the federal Stark Law. The judge disagreed, saying there was no indication that Stark was meant to pre-empt state referral laws.

It was a no-go on a verdict in the infamous gun sting FCPA trial. After six votes, jurors in the case were unable to reach a verdict, and a mistrial was declared by the judge. The government says it will retry the case.

As we wrap up this edition of the News Week in Review, we’d just like to wish the final four astronauts of the shuttle program good luck and Godspeed on their mission. We’ll see you back here on earth July 20th. Yes, you read that right. Atlantis is scheduled to return to earth on the anniversary date of man landing on the moon. The whole thing calls for a Tang toast don’t you think?

Have a great weekend everyone!

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