Teva launches generic Lexapro, awarded 180-day exclusivity
Teva Pharmaceutical Industries Ltd. announced on March 14 that it has commenced commercial launch of escitalopram oxalate tablets, the company’s generic version of Forest Laboratories’ depression and generalized anxiety disorder treatment Lexapro tablets.
The branded product had annual sales of approximately $2.9 billion in the United States, based on IMS sales data. As the first company to file an abbreviated new drug application containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
"These psychiatric conditions can be disabling and prevent a person from doing everyday activities," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options."
American Diabetes Association: Proposed House budget could harm Stop Diabetes efforts
ALEXANDRIA, Va. — Changes to the House of Representatives’ budget for the upcoming fiscal year could put an American Diabetes Association movement at risk, the ADA said.
In a statement issued Wednesday, the organization said that the House resolution cuts $19 billion from overall discretionary funding for fiscal year 2013, compared with the current year. The American Diabetes Association’s Stop Diabetes movement, launched in 2009, would be affected by this cut, ADA said, noting that the budget resolution would "alter essential health programs and jeopardize vital diabetes research and prevention programs." The ADA also added it was concerned about "the devastating impact" the budget cut will have on the future of discretionary public health programs, including the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, the Centers for Disease Control and Prevention’s Division of Diabetes Translation and its National Diabetes Prevention Program.
"We are dismayed that the brunt of the efforts to reduce the deficit is falling disproportionately on critical programs providing a lifeline of research, prevention and treatment services to people with diabetes and other health needs," the association said in its statement. "The House resolution leads us down a path to reducing funding for diabetes research and prevention programs, one that will severely damage our nation’s response to the diabetes epidemic and its devastating and costly complications, such as amputations, blindness, heart disease and kidney failure."
The association also said another part of the House resolution concerns them: turning Medicaid into block grants to the states. About 3.5 million Medicaid enrollees have diabetes and that losing access to coverage would have a detrimental impact on their health, ADA said.
"[The association] recognizes the difficult financial situation our country faces; however, weakening life-saving programs like Medicaid and Medicare and harming our research and prevention efforts will further burden vulnerable populations and lead to a deterioration in public health," ADA said. "This will drastically affect the nearly 105 million Americans with diabetes or prediabetes who are counting on these programs."
The American Diabetes Association will host its annual Diabetes Alert Day is March 27.
NACDS kicks off RxImpact Day with praise for newly introduced legislation
ALEXANDRIA, Va. — In anticipation of hundreds of meetings between pharmacy advocates and members of Congress and their staff as part of NACDS RxImpact Day on Capitol Hill, the National Association of Chain Drug Stores sent a letter to Rep. Cathy McMorris Rodgers, R-Wash., applauding the introduction of her legislation on Tuesday that would establish Medicare standards for pharmacy audits and reimbursement by pharmacy benefit managers.
The bill was introduced as hundreds of pharmacy advocates fly to Washington, D.C., for more than 300 meetings with lawmakers and their staff to discuss opportunities to further leverage neighborhood pharmacy to advance patient health, reduce costs and spur the local economy. Pharmacy advocates — including NACDS members, pharmacists, pharmacy students and chain pharmacy leaders — already have begun converging in the nation’s capital for the fourth annual NACDS RxImpact Day on Capitol Hill, held March 21 and 22.
The new legislation, the Medicare Pharmacy Transparency and Fair Auditing Act (H.R. 4215), would require PBMs to provide pharmacies with vital information on reimbursement for life-saving drugs and community pharmacy-provided services to Medicare Part D beneficiaries. The legislation also would help guarantee the utilization of appropriate pharmacy audit standards for PBMs contracting with the Medicare Part D program.
“Despite their claims to the contrary, PBMs drive up prescription drug costs through their opaque practices, restrict consumers’ choice of pharmacy, and use gimmicks to deny payments to pharmacies,” NACDS president and CEO Steve Anderson wrote in the letter. “Nothing is more important to chain pharmacy than the health and safety of their patients. We stand with you in your commitment to protecting the well-being of senior Americans.”
The legislation also would prohibit reduced pharmacy reimbursement stemming from clerical or recordkeeping errors, and ban extrapolation or other statistical tricks to unfairly calculate pharmacy recoupment and penalties.
“Your legislation will ensure that PBMs do not keep for themselves any payments recovered from their audits and that such payment recoveries are returned to the Prescription Drug Plan (PDP) sponsor,” Anderson stated. “Your legislation is an important step toward fully reining in the egregious practices of the PBMs.”
Last year, NACDS endorsed related bipartisan PBM transparency legislation, introduced by Rep. McMorris Rodgers and Sen. Mark Pryor, D-Ark. That bill, the Pharmacy Competition and Consumer Choice Act (H.R. 1971 and S. 1058), includes provisions related to the frequency of updating maximum allowable cost (MAC) pricing, data usage, and the forced utilization of a PBM’s own mail-order pharmacy, among other steps to prevent threats to pharmacy patient care.
Along with underscoring chain pharmacy’s support for the PBM transparency and standards bills, pharmacy advocates this week will urge lawmakers to oppose the proposed merger of PBMs Express Scripts and Medco, whose union, according to NACDS, would likely only exacerbate the problems highlighted by the legislation. NACDS members and other pharmacy advocates will also promote the adoption of legislation to increase access to medication therapy management services and ensure fair and adequate pharmacy reimbursement in federal healthcare programs.