The PharmaCertify™ Team

To borrow a quote from Yogi Berra, it was déjà vu all over again with this week’s big story. The long awaited release of guidance from the FDA regarding use of social media by industry was delayed…again.  The FDA gave no timeframe as to when to expect their guidance.

Other activity from federal agencies this week included an announcement from HHS that training would be offered to the state attorneys general on how to file HIPAA lawsuits. The HITECH provision allows states to bring lawsuits regarding HIPAA violations. For your reading pleasure, the OIG posted updated CIA information.

In the Federal Court of Appeals for the 4th Circuit, a divided court held up a lower court’s ruling that the secrecy provision for False Claims Act suits brought by whistleblowers does not violate the public’s right to access court proceedings. The court said the provision does not prohibit whistleblowers from discussing the fraudulent actions which are at the center of the suit, but just from revealing that a qui tam lawsuit has been filed.

In state news, the Kentucky Attorney General, Jack Conway, announced a $10.2M settlement with Alpharma USPD, Inc. and Purepac Pharmaceutical Co. over inflated Average Wholesale Pricing.

This week both Pfizer and GSK released information about monies paid to physician for their services as consultants, speakers, clinical trials and for other items. And speaking of aggregate spend, if you missed our webinar “Practical Strategies and Tips for Aggregate Spend Compliance Training” with Kim Life, it is now available at pharmacertify.com.

Across the Pacific, the chief executive of industry group, Medicines Australia, says the “industry feels besieged” in the wake of a slew of new laws aimed at the industry. The Medicines Australia chief believes these laws will make it even more difficult for the industry to compete in the world market, hurting the $4B export market in Australia.

In an interview, former DOJ deputy chief, Mark Mendelsohn, says the trend toward prosecuting individuals for violations of the Foreign Corrupt Practices Act is likely to continue. A subscription is required to read the full Wall Street Journal article.

That’s the PC news roundup for this week. Remember, PharmaCertify has the subject matter expertise and solutions you need to train on critical compliance topics like HIPAA, On-Label Promotion and the FCPA. Please visit us at www.pharmacertify.com for more information. Until next week check out our blog, and follow us on Twitter.

Enjoy the weekend!