The PharmaCertify™ Team

Shut out and shut down. No, not the Atlanta Braves or Boston Red Sox with their spectacular season ending meltdown, (we can see where one might think that); we’re referring to the NBA’s season opener and who knows how many more regular season games. Contract talks between players and management went no where on Tuesday, so the lockout continues and the season opener appears done for. The good news is both sides are meeting today, so fingers crossed folks. As we wait with baited breath to find out whether we’ll have the joy of seeing Justin Timberlake and Jack Nicholson sitting courtside at Lakers games, check out what news dribbled in here at PC News. Let’s kick off this week’s review. (wait, that was a football reference!) Ally oop! Here we go.

With the full court press on against the financial ties between physicians and the industry, a psychiatrist stands up to point out the educational benefits physicians receive from attending company sponsored education event. The physician, a paid speaker himself, spoke of the positives of learning how colleagues are using certain drugs. He also says talking to other physicians at these programs allows physicians to identify side effects once the medications are used in the “real world.”

HHS’ Agency for Healthcare Research and Quality (AHRQ) is calling a foul on the off-label use of atypical antipsychotic drugs. The AHRQ released an article saying research shows little evidence that the drugs are effective for anything other than the use for which they are approved. Doctors prescribe antipsychotic drugs to treat other conditions such as insomnia and eating disorders. There was some evidence that three drugs in the class were effective in treating dementia, general anxiety disorder and OCD. Beyond the specific drugs cited for the specific conditions, there was no evidence that atypical antipsychotics were effective at treating those same conditions or other conditions for which they might be used off-label.

Federal prosecutors are hoping for a slam dunk this time as the second FCPA sting trial got under way this week. Defendants in the case are accused of bribing foreign officials of Gabon in order to secure lucrative arms contracts. The “foreign officials” were actually FBI agents. Defense lawyers accuse the government of inventing a crime and claim their clients are victims of a shoddy, overzealous investigation. The first trial ended in a mistrial after the jury could not reach a verdict.

Cephalon may find itself in “contract talks” with the government again over off-label promotion allegations. In an SEC filing, the company disclosed it had received a subpoena from the US Attorney’s office for records related to a leukemia drug. No comment from Teva as to what impact, if any, this development will have on its acquisition of Cephalon.

A couple of FCA settlements were announced involving medical device companies. Guidant will lay up (err…lay out) $9.25 million to settle allegations it failed to provide promised warranty services on its defibrillators and pacemakers. Durable medical equipment supplier Hill-Rom will pay $41.8 million to settle allegations it submitted claims for its bed support surfaces for patients who did not qualify for the equipment.

During her comments at the Advanced Medical Technology Conference, HHS Secretary, Kathleen Sebelius, said the government would like to see improvement in the medical device approval process, but more resources would be needed. This means higher user fees. She credited the implementation of a user fee program in the pharmaceutical industry for speeding up the drug approval process. The government and medical device industry have been in talks over a new user fee, but no progress has been made.

The possession arrow is now pointing back to Kentucky in its lawsuit against Purdue Pharma over OxyContin. The state and Pike County, KY filed suit against the company in 2007, alleging the company lied about the addictive nature of the drug, thereby costing the state and county millions in healthcare and law enforcement costs. The case was moved to a federal court in NY in 2008. The Kentucky AG argued that the case should be sent back to Kentucky, and a federal judge in NY agreed.

The shot clock is about to run out on CMS. Regulations for the Sunshine Act are due by October 1! Hope they make it. Vermont marketing disclosure reports are also due October 1. It’s the last state report due for the year. And speaking of state and federal disclosure laws, PharmaCertify can help you train the folks in your organization affected by these laws as well as state laws which prohibit or ban the provision of gifts. Our State and Federal Spend and Disclosure Laws is designed to allow your reps to focus on just the laws that apply to them.

We’re nearing the final buzzer on the work week, and we are happy to let the clock just run on out. Hope you all have a great weekend, and we’ll see you right back here next week for the PC News Week in Review.