The PharmaCertify™ Team
There’s nothing like a short work week to help get the days of the week confuzled. While last week may have been a short work week, there was no shortage of compliance news. So kick back and check out the week that was in PC News.
The implementation of the U.K. Bribery Act is just a month away, and the Feds have ratcheted up their enforcement of the FCPA. FCPA expert, Kevin Bennett spoke with the Star Tribune about the similarities and difference in the two laws. Additionally, Bennett discussed the trend toward increased FCPA due diligence in mergers and acquisitions.
Up on the Hill, two US Senators were busy suggesting further regulations for the FDA. Senator Max Baucus called for the FDA to require physician groups and doctors to reveal any ties to the drug industry when lobbying the agency. The call comes as the result of a revelation in a Senate Finance Committee report that a physician group, who had accepted millions of dollars over the years for conferences and sponsorship from Sanofi, had written letters to the FDA questioning the safety of generic drugs. According to the report, the letters were written at Sanofi’s urging. On a separate topic, Senator Chuck Schumer proposed legislation that would require drug manufacturers to notify the FDA when they anticipate shortages on products.
News of the government stepping up its efforts to prosecute individual executives in healthcare fraud cases continues to grow as MSNBC and the AP joined in on the coverage. More proof that training on the False Claims Act and Anti-kickback Law is crucial for your reps AND your executive committee.
Abbott is in settlement negotiations with the DoJ over False Claims related to the off-label promotion of an anti-seizure medication. Government attorneys asked the judge in the case to postpone proceedings until July 8 so settlement negotiations can continue. The case is in the US District Court of Western Virginia, and several other states have joined in the suit as well.
Despite promises to provide guidance to the industry, the FDA did not put use of social media on its Guidance Agenda for 2011. On the agenda instead is “Responding to Unsolicited Requests for Drug and Medical Device Information, Including Those Encountered on the Internet.” With no social media specific guidance on the way, the question facing the industry now is to Facebook or not to Facebook. Except for pages dedicated solely to a prescription drug, Facebook will no longer allow the “comment feature” to be disabled on industry pages. So how does a company create a forum for a truly open dialogue with consumers, while ensuring that they stay in the good graces of the FDA? Stay tuned as the industry returns once again to the digital media strategy drawing board.
Last week we shared the good news of our new arrival, Good Promotional Practices. While you’re here on the blog, check out our new entry on why GPPs offer a compelling and effective foundation for training. And for information on how we can help with training on subjects in the news this week, like the FCPA and on-label promotion, visit our website.
It’s back to the usual five day grind this week, we hope you enjoyed the weekend everyone!