The PharmaCertify™ Team

Well that was some lovely August week. Oh wait….it’s only June. Whew! It has been H-O-T, HOT! Here’s hoping it cools off outside soon, but in the mean time, stay indoors and enjoy some A/C as you read this week’s PC News Week in Review.

Speaking of the heat, the OIG uploaded video of its recent provider compliance training. The training was provided as a part of the agency’s HEAT program.

One company feeling the heat this week was UCB. The company pleaded guilty to a misdemeanor and will pay $34 million in fines and penalties for the off-label marketing of an epilepsy medication. The False Claims Act case resulted from two whistleblower claims and US and state Medicaid systems will share nearly $26 million of the $34 million dollar settlement.

Feeling the heat in the courtroom were former Synthes executives awaiting sentencing for their part in an unauthorized clinical trial for a bone cement. The executives were charged under the Park Doctrine. The US is pushing for prison time in the case, which would make this the first time the Doctrine was used to send executives to prison.

Off-label marketing proves to still be a hot topic and the New Jersey Star-Ledger discusses the topic in depth.

Likewise, FCPA enforcement is a hot topic these days, and will be the subject of a Judicial Committee hearing next week. The hearing was scheduled at the direction of committee chairman, Representative Lamar Smith of Texas. In May, Rep. Smith’s senior counsel announced that the committee wanted to review whether reforms or fixes were needed, and that staffers were looking at four potential changes. No specific reform has been proposed by any member of Congress.

The heat is on across the pond as well. Several drug manufacturers were found to be in violation of various parts of the ABPI Code of Ethics. The breaches ranged from failure to provide sufficient prescribing information to the Prescription Medicines Code of Practice Authority to inappropriate hospitality being provided to doctors.

Off-label prescribing was also a topic the ABPI tackled this week. The ABPI told the General Medical Council (GMC) it was opposed to medicines being prescribed for off-label use, when a licensed alternative was available. The GMC raised the issue in the wake of two high-profile cases where cheaper drugs, not licensed for a particular condition, were prescribed over the more expensive, licensed drug. The group is concerned about the potential risk to patients when less expensive alternatives are used for off-label purposes. GMS is also concerned that off-label use will hinder new drug development.

Former federal prosecutor, Michael Loucks, now finds himself in the hot seat as a corporate defender. Since joining Skadden, Arps nearly a year ago, he has surprised former allies with his staunch defense of the companies he once prosecuted. Loucks now calls into question practices he once employed as a prosecutor.

In a move that is likely to make attorneys like Mr. Loucks hot under the collar, a federal appeals court ruled that pharmaceutical and medical device companies can be held liable under the False Claims Act, even if the pharmacy or hospital is unaware a kickback was paid for the purchase of product reimbursed through Medicare or Medicaid.

How’s that for a bunch of heat references? Too cliché? Well we can always blame it on the heat. Until next week keep cool, and if you need help training some of the hot topics (had to get one more in) discussed this week, please visit us at www.pharmacertify.com.