The PharmaCertify™ Team

Finally, an agreement has been reached! After months of negotiating, name calling and media posturing, they did it! That’s right folks, there will be NFL football in the fall! As we enter the dog days of summer, we can rest assured that our Sunday afternoons in the fall will be filled with bratwurst and the beverage of your choice. Now that all is right with the world, we can move forward with this week’s PC News Week in Review.

Are there too many players on the field where False Claims Act (FCA) investigations are concerned? Lawmakers, Congress and lawyers seem to think so. Even the DOJ would like to see the cases resolved more quickly. However, with most cases being qui tam (1,341 as of January, according to a letter sent to Sen. Charles Grassley) and those cases taking around two years (or 13 months depending on who you believe) to investigate before the government decides to join in the suit, it seems as if speeding up the investigatory process is going to prove to be quite a challenge. Senators Grassley and Leahy of the Senate Judiciary Committee have introduced a bill aimed at speeding up the process. One law firm is urging companies under investigation to push the government to unseal cases more quickly.

False Claims Act cases aren’t the only ones loading up the line either. FCPA cases are also overloading the docket in federal court. The judge in the well known SHOT Show sting case is faced with a full docket as is, and the government says it will re-try the first group of defendants, whose trial ended in a mistrial. Lawyers are arguing whether this first group should be tried again before proceeding with the other defendants in the case. Lawyers for the government say there has been movement in plea arrangements for several defendants, and that should lower the case burden. The judge however is not convinced the government has the manpower to handle the load, and has told the lead lawyers in the case he will not accept excuses of manpower problems if one of the prosecutors is not able to participate in a trial.

Wisconsin’s largest hospital system has sacked the practice of providing free samples to patients. The ban is effective August 1. A senior vice president with the hospital system said the decision to stop the practice was largely based on safety concerns, but other institutions with similar bans say providing free samples encourages the use of expensive prescription drugs. Wisconsin’s Froedtert Health System enacted a similar ban in 2006 and then saw a 15% rise in generic drug use over the next two years. The ban will allow samples to be distributed in some cases, such as when patient has to learn how to use an inhaler or inject a drug.

Gearing up the offense is Kentucky AG, Jack Conway. This week, he filed suit against McKesson on several charges, including violation of the state’s Consumer Protection Act. The state is accusing McKesson of conspiring with First Data Bank to distort drug pricing information, thus costing the Medicaid program millions of dollars.

EU officials look to tackle the issue of industry-patient communication. Currently the EU bans drug makers from direct communication with patients, but those regulations are now up for review. The new regulations aren’t expected to allow the type of DTC advertising permitted in the US, but they will bring some sort of uniformity. Industry trade groups support the review, saying there is too much disparity in how countries across Europe handle the topic.

Experts at KPMG say the pharmaceutical industry needs to get its game face on when it comes to the UK Bribery Act and the use of CROs. According to the report, the use of CROs poses an increased risk that requires robust contract compliance efforts and increased awareness of what CROs are paying the healthcare providers.

After further review, a federal judge has dismissed two of three charges in an off-label promotion suit against Medtronic. The whistleblower suit alleges that Medtronic actively promoted biliary stents for off-label uses and caused false claims to be submitted. The whistleblowers in the case have charged they were terminated in retaliation for their refusal to go along with the off-label promotion. The judge dismissed one whistleblower’s retaliation charge, as well as the false claims charges, saying the relater failed to provide the detailed information required by the FCA.

We’re putting our name on it, and calling this week’s edition of the PharmaCertify™ News done. Go get ready for some football and head to the sports shop and stock up jersey’s and other assorted merchandise from your favorite NFL team. (Unless that team is the Dallas Cowboys, and then we’ll thank you to spare the assault on our eyes with that stuff). It’s almost football night in America! Have a great weekend everyone!