Week in Review, December 16, 2013

The Serious Fraud Office hits another bump in the road, Brazil expands its anti-corruption efforts, and the Pew Charitable Trusts and the CME Coalition disagree on suggested changes for the industry’s interaction with medical schools.

As the song goes, “the weather outside is frightful.” The string of winter storms over the last week has brought snow for some, ice for others, and a lovely cold rain over much of the country. Welcome to early winter! Yes, we know, the calendar still says we’re in the fall. If you’re one of the unfortunate ones scraping snow and ice off your windshields and sidewalks already, we can’t offer much in the way of help with that shovel, but we can help you catch up on the compliance news you need to know, with this week’s News in Review.

The Serious Fraud Office is facing more stormy weather. The agency abruptly called off the high-profile bribery case against businessman Victor Dahdaleh. Dahdaleh was accused of paying millions in bribes to managers at Aluminum Bahrain (Alba) over a period of eight years.  The trial began in early November, and the SFO had to call an end to their prosecution when two U.S. lawyers who had helped with case refused to testify and a third witness changed his testimony. The two U.S. lawyers also represent Alba in a civil case, which raises questions about whether they should be used in the British criminal case. The case is the latest in a string of embarrassing and expensive missteps for the SFO.

New legislation has been introduced in Canada that would require doctors and pharmaceutical companies to reveal more information about the adverse effects associated with pharmaceutical products. The law would require doctors to notify Health Canada when patients have an adverse drug experience, and pharmaceutical companies would then be required to make immediate changes to a drug’s label to reflect the new safety concerns.

A change in the anti-corruption weather is on the horizon in Brazil. The Clean Companies Act (CCA) will go in effect January 29, 2014. The anti-bribery law shares a number of similarities with the FCPA and U.K. Bribery Act. The law applies to any company or legal entity doing business in Brazil, and applies to the bribery of both domestic and foreign government officials at any level. It also prohibits facilitation payments and implements strict liability for legal entities involved in corruption.

The courtroom had to be frosty when Boehringer Ingelheim was handed a $931,000 fine for losing documents related its Praxada drug. The judge said the company allowed the documents to be destroyed, and that attempts to create back up versions were even thwarted. Further, the company disabled programs that would have preserved voicemail and text messages. The loss of the documents affects 1,700 patient lawsuits.

A report from the Pew Charitable Trusts suggests industry-physician interactions at the nation’s medical schools need to be put in the deep freeze. The recommendations from Pew include the typical ban on rep visits, meals, gifts, etc., as well as a suggestion that school staff not accept speaking fees from pharmaceutical companies.

The CME Coalition would like to put the Pew recommendations on ice though. Senior advisor to the CME Coalition, Adam Rosenberg, says the recommendations in the report are “irresponsible,” and “they are nothing short of dangerous to America’s health.” For example, even though Pew recommends that CME should be free of industry funding, the organization cites no studies or evidence showing that funding is leading to poor patient outcomes, or is unduly influencing prescribing decisions.

And so we come to the end of this chilly edition of the News Week in Review. If adverse events reporting is at the top of your holiday and new year wish list, the newest off-the-shelf module from PharmaCertify™, Adverse Events and Product Complaints, covers the definitions and sources of events and complaints, as well as the information needed to ensure accurate reports are filed. As with all of the PharmaCertify™ solutions, the module is easily customized with your  organization’s procedures and policies.

Stay warm everyone, and have a great week!

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