PHARMACY

FDA approves Chembio’s HIV tests for adolescents, young adults

BY Alaric DeArment

MEDFORD, N.Y. The Food and Drug Administration has approved Chembio Diagnostics’ extension of the testing-age range of its point-of-care HIV tests to people 13 and older, Chembio said Wednesday.

The company said lowering the testing age was consistent with the Centers for Disease Control and Prevention’s recommendations that all people aged 13 to 64 undergo routine HIV screening.

More than 1 million adults and adolescents in the United States have HIV, though about 21 percent are unaware of their infection, and in 2006, 5 percent of the people living with the disease were between the ages of 13 and 24.

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HealthPartners site helps Minneapolis area patients estimate healthcare costs

BY Alaric DeArment

BLOOMINGTON, Minn. A healthcare organization has launched a Web site that quotes prices for 83 procedures at the primary care and radiology centers in its network in the Minneapolis-St. Paul metropolitan area.

HealthPartners announced the launch Tuesday. The price listings are in the ?Find a Provider/Clinic? section of its Web site, www.healthpartners.com.

The prices listed are for five high-volume service categories, including office visits, immunizations and vaccines, lab services, X-rays and CTs and MRIs. For example, a wrist X-ray at one of the clinics costs $61.60, while an influenza test costs $29.18.

“This is an important step forward in transparency because the information we provide is for specific prices rather than a range,” HealthPartners senior vice president for customer service and product innovation Scott Aebischer said. “This information is particularly useful for members who are paying out-of-pocket fees.”

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FDA challenges Bayer’s TV commercial claims about Yaz

BY Alaric DeArment

NEW YORK The Food and Drug Administration told Bayer in a letter Tuesday that two of the company’s TV commercials for its premenstrual dysphoric disorder drug Yaz are misleading.

The FDA said one commercial suggests the drug is approved for treating post-menopausal syndrome by saying it treats irritability, moodiness and bloating—symptoms common to PMDD and PMS. That commercial, which featured women hitting balloons while singing “We’re not gonna take it,” has been pulled.

The second commercial had the song “Good-Bye to You” and women releasing balloons with symptoms written on them. The FDA said evidence has not demonstrated that Yaz eliminates symptoms, even though the commercial suggests that it does.

Yaz (drospirenone and ethinyl estradiol) had global sales of $1.42 billion in 2007, according to Bayer financial data.

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