Generic Pharmaceutical Association praises Pres. Obama’s budget proposal
ARLINGTON, Va. President Barack Obama’s budget proposal, which includes an approval pathway for biosimilars, won praise from the Generic Pharmaceutical Association last week.
“For patients across the country suffering from cancer, diabetes and other diseases, the support stated by president Obama today for a workable biogenerics approval pathway is lifesaving news,” GPhA president and CEO Kathleen Jaeger said in a statement. “With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed.”
The model that the Hatch-Waxman Act of 1984 established for generic drugs provides a five-year period of data exclusivity for branded pharmaceutical drugs, which GPhA favors for biosimilars as well. However, the Biotechnology Industry Organization favors a 14-year data exclusivity period, saying that the Hatch-Waxman model would not provide sufficient time for biotech companies to recoup research and development expenses, thus stifling innovation.
Advanced Vision Research launches new OTC supplement for AMD
WOBURN, Mass. Advanced Vision Research has launched an OTC vitamin supplement for macular degeneration and diabetic retinopathy, the eye disease treatment company announced Thursday.
MacuTrition Eye Vitamin and Mineral Supplement contains fish oil omega-3 fatty acids, vitamin D and green tea extract for age-related macular degeneration and diabetic eye disease. AMD has no cure and is the leading cause of blindless in Americans older than 65. In addition, 5 million of the23 million Americans with diabetes have diabetic retinopathy and macular edema, and 97% of insulin-dependent diabetics will develop retinopathy.
“By targeting oxidation, inflammation and angiogenesis, we take a multi-pronged approach to maintaining eye health, especially in those with diabetes and macular degeneration, including those at risk, i.e. family members,” Advanced Vision Research CEO Jeffrey Gilbard stated.
NAD refers Mead Johnson to FTC
NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising for Mead Johnson Nutritionals’ Enfamil Lipil infant formula to the Federal Trade Commission for further review, following NAD’s third compliance review.
NAD, the advertising industry’s self-regulatory forum, initially recommended in April 2008 that Mead Johnson modify or discontinue certain claims for the product or clarify the claims to assure that consumers are provided with all pertinent information. NAD examined advertising claims for the product following a challenge by Abbott Nutrition, a manufacturer of Similac brand infant products.
NAD recommended then that Mead Johnson make clear that Enfamil Lipil has not been shown to outperform Similac Advance with respect to mental and/or visual development. Further, with respect to a consumer-directed coupon that featured a chart inviting consumers to “compare the differences” between Enfamil Lipil and Similac Advance, NAD recommended that the advertiser either discontinue this comparative advertisement, or modify it by removing the comparison to Similac Advance.
Since its initial inquiry, NAD has opened three compliance reviews related to the same or similar advertising claims, including reviews in June 2008, November 2008 and February 2009.
In the most recent compliance proceeding, NAD again found that the Enfamil Lipil advertising did not comply with NAD’s decision, NAD stated. NAD noted in its decision that the “self-regulatory process cannot function properly when advertisers state, on the one hand, that they respect the process and will comply with NAD’s decision, and then do the opposite. Accordingly, NAD has no choice but to refer this matter to the appropriate government agency for possible law enforcement action pursuant to section 4.1(B) of the NAD/NARB Procedures.”