CDER responds to Senator’s inquiry
WAHSINGTON As the Food and Drug Administration prepares its response to the question from Sen. Sherrod Brown, D-Ohio, on how best to hold drugmakers accountable for drug quality, the Center for Drug Evaluation and Research’s Office of Compliance is highlighting the agency’s efforts to examine the drug supply chain, reiterating regulations that the New Drug Application holder is responsible.
“Ultimately the dosage form manufacturer with its name on the label is responsible,” the Office of Compliance said. “Our regulatory structure under the [Food, Drug and Cosmetic] Act, and implementing regulations, provide for the identity, strength, quality and purity of the drug and the prohibited acts provide for civil sanctions and criminal penalties for failure to do so.”
The office commented on the best way to hold firms accountable for drug quality incidents, such as the heparin contamination, in which the manufacturer complies with FDA regulations—passing inspections and conducting U.S. Pharmacopeia tests on incoming products—but unknowingly distributes adulterated drugs anyway.
“In light of the question on how to deal with incidents such as heparin, sourcing ingredients, testing and [control of the] supply stream … are important elements FDA and other regulators are examining and encouraging industry to focus on to prevent such incidents,” the Office of Compliance said.
AMO, IER collaborate on eye care products
SANTA ANA, Calif. Advanced Medical Optics on Monday announced a collaboration with the Institute for Eye Research to develop contact lens disinfectant and cleaning solutions and related products.
“IER’s world-class scientists and clinicians have had a major impact on the development of contact lenses and lens care technologies,” stated AMO executive vice president, research and development Leonard Borrmann. “We look forward to working closely with the IER on the development of next-generation contact lens solutions.”
“Through our collaboration with AMO, we will work to develop, test and deliver, through product innovation and education, the best in contact lens care products,” stated IER chief executive officer Brien Holden. “Our goal is to develop new, safer, better and more convenient initiatives in the field of contact lens cleaning and disinfection systems, including the containers for storage, cleaning and disinfection.”
IER is a non-profit research organization that conducts collaborative and contract research with and for industry in the area of vision correction, eye care, the anterior eye, contact lenses, contact lens care and patient management, to avoid contact lens complications. IER is headquartered in Sydney, Australia.
Report: Americans opting for balanced eating over dieting
ROSEMONT, Ill. According to an NPD Group report issued Monday, the latest fad in dieting may be not to diet at all, but to eat a more healthy diet in the first place.
NPD reported that the percentage of adults on a diet has decreased by 10 percentage points since 1990, while the percentage of Americans eating healthier has increased.
“While dieting for both women and men remain huge markets, they are not growing markets,” stated Harry Balzer, vice president, The NPD Group, and author of Eating Patterns in America. “The desire to lose weight really was a 90’s trend. Today consumers appear to be making healthier food choices.”
NPD’s National Eating Trends data finds that at least once in a two-week period, more than 70 percent of Americans are consuming reduced fat foods, and over half of them are eating reduced calorie, whole grain or fortified foods. In addition to these foods, other “better for you” foods consumed include diet, light, reduced cholesterol, reduced sodium, caffeine free, sugar free, fortified, organic, and low carb varieties. The average American, according to National Eating Trends, has at least two “better for you” products a day.
More consumers are looking to add whole grains, dietary fiber, omega-3 fatty acids, antioxidants and probiotics, according to the NPD Dieting Monitor, which examines top-of-mind dieting and nutrition-related issues facing consumers. Awareness of these nutritional food elements continues to grow. For example, in 2005, 36 percent of consumers surveyed said they were trying to get more omega-3 fatty acids in their diets, and the most recent NPD Dieting Monitor shows that number increasing to 46 percent.