Council For Responsible Nutrition names new members
WASHINGTON The Council for Responsible Nutrition last week added four members to its roster — ingredient manufacturer Ashland Aqualon Functional Ingredients, functional foods supplier Celsius, dietary supplement developer Nutrition 21 and eye supplement marketer ZeaVision.
FDA declines to approve Qnexa
MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.
The company said Thursday that it received a complete response letter from the FDA for Qnexa (phentermine and topiramate) controlled-release capsules. The agency said the application can’t be approved in its current form and asked for additional study data. The FDA issues a complete response letter to indicate that it has completed review of an application, but questions remain that preclude final approval.
The prospects for the drug’s approval didn’t look good even before Vivus submitted its application, despite the drug showing some promise in clinical trials. In July, an FDA advisory committee voted 10-6 against recommending approval for Qnexa, citing such possible side effects as psychiatric problems and birth defects. Though an advisory committee’s vote does not determine whether the agency will approve a drug, its vote is taken into consideration.
In letter, NACDS thanks senator for supporting Tricare
ALEXANDRIA A group representing the drug retailing industry commended a senator’s support of the military healthcare program Tricare.
Sen. Jim Webb, D-Va., who serves as chairman of the Personnel Subcommittee of the Senate Armed Services Committee, said he did not support proposed Tricare premium increases, which would offset the healthcare costs that the Department of Defense have been struggling with. In reponse to this, the National Association of Chain Drug Stores sent a letter to the senator, which said that he exhibited "tremendous leadership in protecting access to healthcare providers and services for Tricare beneficiaries."
NACDS said its position on the matter was in line with the subcommittee, which believes "that savings are more likely to be found through improving business practices and encouraging preventive care, rather than increasing premiums, co-payments, and other beneficiary cost sharing," NACDS wrote to Webb.
The group added that the emphasizing the role of pharmacists in health care is just one of the ways healthcare costs can be curbed, as medication nonadherence costs the nation up $290 billion a year in expenditures, according to the New England Healthcare Institute.