Dept. of Justice files complaint for permanent injunction against dietary supplement manufacturers
ROCKVILLE, Md. The Department of Justice, on behalf of the Food and Drug Administration, on Friday announced the filing of a complaint for permanent injunction against Quality Formulation Laboratories, American Sports Nutrition, Sports Nutrition International and Mohamed Desoky, who oversees operations at all three companies.
The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.
The government’s complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice by manufacturing and storing food under “filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.”
The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.
During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.
FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.
In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections but failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.
“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” stated Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”
Pepcid better than Prilosec when taken with low-dose aspirin, trial finds
NEW YORK The FAMOUS trial, reported in an article in Online First and in an upcoming edition of The Lancet, has found that Pepcid (famotidine) is effective in the prevention of stomach and upper intestinal ulcers, and damage to the gullet, The Lancet noted in a press statement earlier this week.
Low-dose aspirin (75mg to 325mg) is one of the most widely used drugs in the world. Increasingly, it is being bought over the counter or prescribed for its anti-clotting activity in the heart and brain, and in patients with diabetes. Despite the benefits of aspirin use, its rise has been accompanied by a rise in gastrointestinal complications, such as peptic ulcer bleeding, perforation and sometimes death. Such proton-pump inhibitors as Prilosec OTC (omeprazole) can prevent such ulcers but there have been concerns about cost, safety and risk of interaction with clopidogrel, another anti-clotting drug that is prescribed often with aspirin.
In the FAMOUS trial, researchers studied the effect of famotidine, which has a different mechanism of action to PPIs and belongs to a group of drugs called H2-receptor antagonists. The researchers found that stomach ulcers had developed in 3% of patients given famotidine compared with 15% given placebo. Upper-intestinal or duodenal ulcers were found in just one patient (0.5%) in the famotidine group compared with 17% of those given placebo. Gullet ulcers occurred in 4% of famotidine patients compared with 19% of placebo patients. And there were fewer adverse events in the famotidine group (9 vs. 15 placebo).
“Famotidine is effective in the prevention of gastric and duodenal ulcers, and erosive oesophagitis in patients taking low-dose aspirin,” concluded lead author Ali Taha, Crosshouse Hospital, Kilmarnock, England. “There is little doubt that aspirin and other anti-clotting drugs are very useful in the prevention of heart, brain and other vascular diseases, hence their increasing use world-wide. Patients on such drugs should continue using them as advised by their family doctors or hospital specialists. However, everybody should be aware that aspirin use can also be associated with a variety of gastrointestinal or digestive system problems, which sometimes can be serious. The results of this research widen the options for the prevention of such problems particularly when more than one clotting drug is required.”
Take Care: Patients that use workplace primary care, pharmacy services have higher adherence rates
NEW YORK The findings of the Take Care Health Systems’ survey are important as they undoubtedly underscore the importance of worksite clinics, which are growing increasingly common as U.S. employers look for ways to curb skyrocketing healthcare costs and bolster employee health and productivity.
The study highlights what clinic operators — like Take Care Health Systems with its 300-plus worksite clinics — have known for some time: investing in integrated workplace health and pharmacy programs can, in fact, help employers realize healthcare savings, while improving patient outcomes.
What is the cost savings? As reported in late 2008 by Drug Store News, an August 2008 report by human resources consulting and outsourcing services provider Hewitt Associates, dubbed “Trends in HR and Employee Benefits: Employers Implement On-Site Health Clinics to Manage Costs,” states that some studies suggest that worksite clinics lead to $2 in savings for every $1 invested, and some may even reach $3 to $6 in savings for every $1 invested. Citing data provided by On-Site Health Care, the Hewitt Associates report also states, “For prescription drugs, employers may see 11.9% in brand savings and 56.3% in generic savings.” Then, of course, there’s the issue of medication adherence, which the Take Care Health Systems’ survey clearly addresses. With an estimated price tag of $100 billion, non-adherence is a major drain on the U.S. healthcare system.
Given the results of this study and the trends that are already taking place throughout the convenient care industry, employer-based clinics are something the industry is bound to see on the upswing. In fact, industry sources have suggested that the market could bear as many as 5,000 worksite clinics as the ideal client is an employer with 1,000 or more employees at a site.