K-V to ship first product since 2009 manufacturing problems
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.”
Pittsburgh Business Group on Health’s LivingMyLife program to expand
PITTSBURGH The Pittsburgh Business Group on Health’s LivingMyLife program, which helps diabetes patients with disease management through the use of “coach pharmacists,” will soon do the same for those with other diseases, according to published reports.
The Pittsburgh Tribune-Review reported Friday that LivingMyLife also would help patients with asthma and heart disease. The program, which began in 2006, allows patients to manage their disease with visits to pharmacies, mostly Giant Eagle, Kmart and some independents.
The announcement was made at the annual healthcare symposium of the group and involved more than 100 attendees, the newspaper reported.
DSC debunks industry misconceptions at briefing
WASHINGTON The Congressional Dietary Supplement Caucus, in cooperation with two trade associations representing the dietary supplement industry — the Natural Products Association and the Council for Responsible Nutrition — held a briefing on Capitol Hill Thursday in an effort to debunk some of the untruths and misconceptions about the dietary supplement industry and its role in Americans’ wellness regimens.
“It’s all about prevention. Prevention is the new mantra among consumers,” suggested guest speaker Patrick Rea, publisher and editorial director of Nutrition Business Journal.
Speaking to an audience of staff members from the House of Representatives and Senate, Rea said that even during tough economic times, consumers turn to dietary supplements as an important part of their immunity and prevention plan.
“Consumers looked at supplements as one way through the recession to help take care of themselves. Health is recession resilient, and the sales over time support this fact,” Rea said.
Rea addressed several “industry myths” –– including the notions that dietary supplements are unnecessary because people get what they need from food, that people really do not want to take supplements, that the pharmaceutical industry will destroy the dietary supplement industry and that the industry is unregulated.
“Our numbers show that somewhere between 60% to 80% of Americans take supplements, and 48% of them consider themselves regular users,” Rea said.
Rea also mentioned the growing acceptance of dietary supplements among conventional health practitioners, and the growing trend among pharmaceutical companies to develop their own versions of products usually sold as supplements.
“In a study of healthcare professionals, 72% of physicians and 89% of nurses are dietary supplement consumers, and 79% of physicians and 82% of nurses recommend dietary supplements to their patients,” Rea noted.
Regarding industry regulation, Rea countered that the supplement industry is one of the more highly regulated industries and that the industry welcomes those regulations. “[For example], a lot of the [dietary supplement] companies are rallying behind the [good manufacturing practices] regulations,” he said. “They want it to be known that they are a GMP-compliant company. And, the Dietary Supplement Health Education Act made claims rules clear and has really helped the industry focus and develop.”