FDA shuts down unapproved Glenmark, Konec drugs
SILVER SPRING, Md. The Food and Drug Administration has ordered two generic drug companies to stop marketing unapproved heart attack drugs as part of its Unapproved Drugs Initiative, the agency announced Tuesday.
The FDA ordered Mahwah, N.J.-based Glenmark Generics and Tucson, Ariz.-based Konec to stop marketing nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or stop a heart attack.
The FDA announced the initiative in 2006 to address the issue of companies marketing drugs that entered the market before the agency adopted its current regulatory policies, which has allowed them to be marketed without the agency’s approval.
“Doctors and patients should know that not all drugs on the market are backed by FDA approval,” FDA Office of Compliance director Deborah Autor said. “This lack of approval undermines the FDA’s efforts to ensure that safe and effective drug products are available to the American public.”
The FDA has given the two companies 15 days to respond to the warning, 90 days to stop manufacturing the tablets and 180 days to stop further shipment of them. The initiative allows the companies to win approval for the drugs if they undergo FDA review.
NCPA: Drug manufacturers should pay rebates in DoD’s Tricare program
ALEXANDRIA, Va. The National Community Pharmacists Association expressed support of the U.S. Department of Defense’s efforts to collect the same manufacturer rebates for the Tricare retail pharmacy program that are applicable to prescriptions filled at Tricare mail-order pharmacies and military treatment facilities.
Tricare beneficiaries may lose face-to-face interaction with their pharmacists if such reimbursements are not provided to them, NCPA said. Currently, prescriptions used in the Tricare retail pharmacy network are subject to federal ceiling prices under law. NCPA believes that the DoD shouldn’t be denied billions of dollars in rebates from drug manufacturers, or make Tricare members solely use mail-order prescriptions.
“The Department of Defense provides prescription drug benefits to active duty, reserve, and retired military families and wants to reduce cost, maintain access and produce the best health outcomes possible,” said Bruce Roberts, NCPA EVP and CEO. “However, drug manufacturers undercut those goals by not paying their fair share of federal ceiling prices. Studies indicate pharmacists are critical to patients in impacting medication adherence, but if drug manufacturers continue to only pay rebates for mail order prescriptions then that won’t occur. The Department of Defense should hold the drug manufacturers accountable for all their financial obligations.
“Without changes, the choice Tricare beneficiaries take for granted about where to get their prescription drugs might fall by the wayside as increased use of mail order would become an unfortunate, but possible reality,” added Roberts.
Report: Lilly drugs stolen out of warehouse
HARTFORD, Conn. Burglars stole $70 million worth of prescription drugs from an Eli Lilly warehouse, according to published reports.
The Associated Press reported Tuesday that the burglars disabled the alarm, climbed the wall, cut a hole in the roof and rappelled inside the warehouse, in Enfield, Conn. Drugs stolen included anti-depressants and anti-psychotics, though there were no painkillers in the warehouse. Law enforcement officials told AP that they stole enough to fill a tractor-trailer.
The FBI has been called to investigate, AP reported.