Week in Review, April 20, 2012

The PharmaCertify™ Team

Happy Earth Day everyone! So what are your plans for the day? We’ll be reducing, reusing and recycling here at the Week in Review. And, to celebrate Earth Day and Disney’s Animal Kingdom’s 14th anniversary (April 22nd), we may even take in a screening of the new film, Chimpanzee. Before you head off to get all green for the day, take a gander at the collection of electrons we call the PharmaCertify Week in Review.

We’ll start this week’s review with a story from a land known for its glorious green color, Ireland, where a program titled, “Solutions for Wellness,” is being launched by mental healthcare professionals. The program is sponsored by a drug company that manufactures psychiatric medication, and the company’s logo can be found in the print materials. Although no drugs are mentioned, the program has caused some to voice concerns about the line between promotion and education and conflicts of interest between the industry and the medical community. The Irish Pharmaceutical Association says companies are within their rights to support education campaigns as long as they do not mention a specific product, and that they work diligently to keep member companies apprised of their responsibility in this area.

The supporters of a new bill in the U.S. House of Representatives are hoping to have the FDA create some green in the life sciences industry. The bill, introduced by Mike Rogers of Michigan, would change the mission of the FDA. The new mission would include advancing public health by speeding innovation and spurring economic growth and job creation. The notion to change the mission statement was brought up several weeks ago during a hearing and again last week at a House committee meeting about industry user fees. The heads of both the medical device and drug divisions of the FDA are opposed to the changes, as is the consumer protection group, Public Citizen.

A government group in India wants to “clear the air” and let the Sunshine in. In a report to the Planning Commission, a steering committee on health suggested that India consider putting in to practice reporting requirements like those found in the U.S. Sunshine Act. The recommendation came along with a call to make the voluntary code of conduct created by the Department of Pharmacy mandatory.

A new study in Canada shows eleven percent of drugs are prescribed off-label, raising concerns about side effects and other consequences. Of the prescriptions written for off-label uses, 80% were for purposes for which there was no scientific evidence to support the usage. Central nervous system drugs were the ones most often prescribed for off-label uses.

There will be a little less cash in the coffers to cover the costs for the Earth Day party at a medical supply company in Tennessee. The company agreed to pay $18 million to settle allegations it violated the False Claims Act. After advertising free cookbooks to Medicare beneficiaries and verifying respondents to the advertisement were in fact Medicare recipients, the company allegedly sent the cookbook, along with medical supplies, to the individuals. They then billed Medicare and TennCare for the supplies. When the individuals returned the unwanted supplies, the company neglected to refund the money paid to the healthcare programs for reimbursement. In other settlement news, GSK has agreed to pay Idaho $2.8 million to settle charges the company overcharged the state’s Medicaid program.

Apparently, U.K. businesses need to look at recycling whatever training they have on the Bribery Act. A survey of 1,000 U.K.-based middle managers finds that just over 70% of them are not familiar with the Bribery Act. Of those who knew about the Act, over half said they had not received adequate training to be compliant. Representatives from Ernst and Young, who conducted the survey, say that businesses may have been lulled into a false sense of security due to the lack of reported cases.

Well, that brings us to the end of another Week in Review. Have a great and green Earth Day everyone!

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