FDA issues warning to Bayer regarding sale of not-yet-approved aspirins
WASHINGTON The Food and Drug Administration has issued warning letters to Bayer HealthCare concerning two unlawful, OTC aspirin products, the agency said in a release Tuesday.
The two products, Bayer Women’s Low Dose Aspirin Plus Calcium and Bayer Aspirin with Heart Advantage contain aspirin with either calcium or phytosterols and are unapproved new drugs requiring an approved application for the company to market them, the FDA said. In addition to being labeled for use as pain relievers, both are labeled as reducing the risks of heart disease. Bayer Women’s is also labeled for use in fighting osteoporosis. Still, the FDA has not approved either product for these uses.
“The FDA considers these products new drugs, and thus, they must undergo the FDA’s drug approval process,” FDA acting associate commissioner for regulatory affairs Mike Chappell said in a statement. “The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”
Under its OTC drug monograph system, the FDA allows marketing of some drugs without prior agency approval. These drugs must comply with regulations that set requirements for the drugs’ labeling and formulation, as well as the uses for which they can be marketed.
The FDA said the two Bayer drugs did not meet the conditions in any OTC monograph and did not have FDA approval, making them unapproved new drugs.
Bayer launched Aspirin with Heart Advantage earlier this year. Controversy over the product’s marketing erupted when the American Herbal Products Association sent a letter to the FDA challenging the launch of the product and requesting that the agency clarify its policy on OTC products combining drugs and dietary supplements, Drug Store News reported in June. At the same time, however, the Council for Responsible Nutrition did not object to the product’s launch.
Price, value sway U.S. consumers when choosing OTC medicines
SCHAUMBURG, Ill. Consumers in the United States place more importance on price and value when buying OTC medications compared to global consumers, according to an online survey conducted by The Nielsen Company and the Association of the European Self-Medication Industry.
Results of the survey, released Monday, showed that Americans ranked second in considering price of OTC products important, at 30 percent, compared to 33 percent of consumers in Japan. At the same time, 17 percent of global consumers consider price. A quarter of American consumers consider whether the product is a good value for money, compared to 15 percent of global consumers.
“With increasing medical costs and a fragile economy, the U.S. consumer is more price and value centric than ever,” NielsenHealth managing director Matt Dumas said. ”These findings highlight the rising importance of generic drugs in the U.S. market, which is underscored by low OTC product loyalty scores versus global markets.”
The survey included 28,253 Internet users in 51 markets in Europe, Asia Pacific, North America and the Middle East and was conducted between April and May.
Bowel-friendly iron pill to be released OTC
CHICAGO A dual-action iron supplement pill with almost no gastrointestinal side effects will soon be available without prescription, the maker has said.
Alaven announced the supplement, Bifera, at the American Dietetic Association Monday. The supplement provides protein-based and plant-based iron and will become available early next year.
“When patients are deficient in iron, their organs aren’t performing at maximum capacity, and they experience a decrease in energy,” the supplement?s product manager, Autumn Akin, said. “Similar to a hybrid car, Bifera is small, efficient and produces energy quickly without unwanted side effects, like nausea and constipation.”