The PharmaCertify™ Team

Bright colors, green grass and the search for small round objects await us this weekend. Yes, it is that time of year again folks; its Master’s time, golf’s storied event. Where legends are made, and the greatest of the great find themselves brought to their knees by the course’s challenging twists, turns and temptations. Joy and disappointment played out before us all in the pursuit to be the owner of what has to be one of the ugliest pieces of clothing in professional sports…the coveted green jacket. Well we’re all pretty excited for this year’s tournament, but before we stake out our spot somewhere in Amen Corner to watch the spectacle, we have a little bit of business to take care of here, this week’s News Wweek in Review.

Pharma, AdvaMed and BIO are concerned with the FDA’s current lie on its guidance for handling unsolicited requests for off-label information. Comments submitted to the FDA by the three industry groups were generally supportive of the guidance’s objectives, but each had concerns with some aspects of the document. All three groups were concerned with the FDA’s handling, or lack thereof, of oral requests for information. The groups say treating oral requests as written requests is not practical, and creates a burden that is not in the interest of the public health or scientific discussion. PhRMA and AdvaMed also said the FDA needs to provide specific guidance on the use of social media. AdvaMed made the point that companies should be allowed to respond in a timely manner with truthful, non-misleading information online, rather than just through traditional off-line methods.

Next we’ll shoot over the water hazard known as the Atlantic Ocean, to Britain, where a group representing various healthcare and life sciences organizations came together to create a set of guidelines for working with the pharmaceutical industry. The group, known as the Ethical Standards in Health and Life Sciences Group, hopes to forge a collaborative partnership with the pharmaceutical industry in order to better patient’s lives. A statement of best practices was created and signed by organizations involved with the group. The document describes the current environment in which healthcare providers and the pharmaceutical industry operate, and rules by which each will abide as they interact.

Certain Asian countries may need to consider teeing up new local anti-corruption laws. Singapore, a country that has traditionally been tough on corruption, has found itself dropping from the number one position to the number five position on Transparency International’s Corruption Perceptions Index. It may be time for Singapore, and other countries in Asia, to take a page from the UK Bribery Act and address not only bribery of government officials, but also corporate bribery.

The FDA could be guilty of slow play where medical device approvals are concerned, according to a report from the General Accounting Office. The GAO report says the FDA is technically meeting its approval time lines for 510(k) devices, but that time line stops when the FDA asks a manufacturer to provide more information. When the time that occupies that process is factored in, device approvals timelines have increased from 100 days in 2005 to 161 days in 2010.

A federal judge gave a former sales representative permission to play through on her wrongful termination lawsuit. The former rep questioned her training that she claims encouraged the promotion of a heart device for an off-label purpose. She questioned the legality of what she was being asked to do during training, and was reprimanded. The rep continued to raise concerns that the off-label promotion could violate the False-Claims Act, at which point her employer then invented reasons to fire her, according to her argument.

Well we’ve approached the 18th fairway and are heading for the green of the weekend. We hope you all have a wonderful weekend, and remember…see the ball, be the ball.