HEALTH

GPhA joins the Partnership for Safe Medicines

BY Alaric DeArment

WASHINGTON The lobby for the generic drug industry is joining the fight against counterfeit drugs.

The Generic Pharmaceutical Association announced Tuesday that it had joined the Partnership for Safe Medicines, which works to protect the global prescription drug supply chain from counterfeit and contraband drugs.

“GPhA and its member companies are committed to medicines of the highest quality, safety and effectiveness,” a statement by GPhA read. “We are pleased to add our voice to those of PSM members working to inform consumers, healthcare professionals and policy-makers about the dangers of counterfeit medicines.”

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K-V to ship first product since 2009 manufacturing problems

BY Alaric DeArment

ST. LOUIS Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in 2008 and 2009 due to manufacturing problems, the drug maker said.

K-V said the Food and Drug Administration had given it approval to ship its Micro-K potassium chloride product following the completion of inspections of its manufacturing plant.

Ethex, K-V’s generic drug marketing and distribution division, pled guilty in February to two felony counts of failing to file alerts to inform regulators of manufacturing problems in 2008, and agreed to pay $27.6 million to the federal government to resolve the investigation. The settlement allowed K-V to continue manufacturing drugs once it had regained compliance with the FDA’s current good manufacturing practices regulations.

In March 2009, the FDA filed an injunction against K-V to prevent it from making or distributing adulterated and unapproved drugs, and forced the company to destroy the drugs it had recalled, forbidding it from resuming manufacturing until it had been brought back into compliance with regulations.

 

“Today marks a significant milestone in our efforts to restore business operations at K-V,” interim president and CEO Greg Divis stated. “The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current good manufacturing practices requirements.”

 

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CDC issues report on breast-feeding among mothers

BY Michael Johnsen

ATLANTA Three-out-of-4 new moms initiate breast-feeding, according to the “2010 Breast-feeding Report Card” released Monday by the Centers for Disease Control and Prevention. However, only 43% of babies are still being breast-fed at 6 months of age.

The 75% breast-feeding initiation rate meets the nation’s Healthy People 2010 goal, and half of the states have breast-feeding initiation rates above 75%.

“Meeting the national breast-feeding initiation goal is a great accomplishment in women’s and children’s health, but we have more work ahead,” stated William Dietz, director of CDC’s Division of Nutrition, Physical Activity and Obesity. “We need to direct even more effort toward making sure mothers have the support they need in hospitals, workplaces and communities to continue breast-feeding beyond the first few days of life, so they can make it to those 6- and 12-month marks.”

State by state breast-feeding initiation rates ranged from 52.5% in Mississippi to nearly 90% in Utah.

While initiation rates steadily have risen, the number of babies who continue breast-feeding until 6 months and 12 months remains stagnant for the third consecutive year. Only 43% (1.8 million) are still breast-feeding at 6 months, and only 22% (fewer than 1 million) are breast-feeding at 12 months. National Healthy People 2010 objectives call for 50% of new mothers to continue breast-feeding for 6 months and 25% to continue for one year.

Breast-feeding at 6 months of age ranged from over 62% in Oregon to about 20% in Louisiana. Breast-feeding at 12 months ranged from nearly 40% in Oregon and Vermont to 8% in Mississippi.

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