FDA committee recommends approval for obesity drug
MOUNTAIN VIEW, Calif. — A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.
Vivus announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving Qnexa (phentermine and topiramate) for obesity in adults. The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but usually follows them.
"We are pleased with the panel’s approval recommendation in support of the safety and efficacy of Qnexa," Vivus president Peter Tam said. "We look forward to working with the FDA as they complete their evaluation."
The FDA originally accepted Vivus’ regulatory application for Qnexa in February 2010, but the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against recommending approval in July of that year, citing concerns over the safety of the drug. In October 2010, the FDA issued a complete response letter, a notice that it had declined to approve the drug, and requested additional clinical study data.
American Associated Pharmacies partners with RxAlly
SCOTTSBORO, Ala. — American Associated Pharmacies announced that it has partnered with RxAlly, an alliance that includes more than 20,000 pharmacies nationwide that seeks to improve health and reduce costs for pharmacy patients.
"We are actively investing our time, resources and talents in the development of RxAlly," AAP CEO Jon Copeland said. "This is a collaborative effort to better serve our members’ patients and improve the delivery of health care, the likes of which the United States has not seen to date."
AAP is one of largest independent pharmacy cooperatives in America with roughly 2,000 independent pharmacies.
New pharmacy group RxAlly forms to help control overall health costs
LEESBURG, Va. — RxAlly on Wednesday announced the launch of the first-of-its-kind alliance of more than 20,000 pharmacies nationwide, united to help patients achieve better health through personalized pharmacist care while reducing costs.
"There is a need for greater access to health care for patients throughout the U.S.," stated Bruce Roberts, CEO of RxAlly and past EVP and CEO of the National Community Pharmacists Association. "To address this challenge head on, RxAlly advances the role of community pharmacists to one that leverages their extensive clinical training, better equips them to interact with patients, improves patient health and lowers costs."
RxAlly offers a performance network, whose core mission is to generate measurable improvements in patient health outcomes and healthcare costs. RxAlly pharmacists are an integral part of the healthcare system, delivering a range of patient-centric services necessary to assure cost-effective delivery and appropriate use of medicines, which can lead to better, more efficient healthcare nationwide. The RxAlly Performance Network will include pharmacies that demonstrate patient-centric delivery of service and an interest in optimizing health outcomes. At launch, this select network is comprised of thousands of independent pharmacies, numerous regional chains and Walgreens.
"A huge opportunity exists for community pharmacies to play a larger role in the healthcare system and make a difference in patient care. That’s why Walgreens is focused on advancing community pharmacy through closer integration with other healthcare providers and expanding the scope of services offered by pharmacists," stated Walgreens president and CEO Greg Wasson. "We are proud to join RxAlly as part of a performance-based network of pharmacies that will differentiate itself through improvements in health outcomes and other services."
"The launch of RxAlly represents a unique combination of the strengths of community pharmacies with the corporate resources of Walgreens," added present NCPA CEO Douglas Hoey. "Health problems, such as the proper use of medications and the worsening primary care shortage cry out for new solutions. As accessible, highly trained healthcare professionals, community pharmacists are ideally situated to help address these and other needs."
According to the alliance, RxAlly’s mission is to serve three constituencies:
Patients. Patients have an ally to help them feel better. Those who see several doctors and juggle multiple prescriptions gain more control over their care. Pharmacists in the RxAlly Performance Network will take a greater role in coaching and customizing care plans that meet the needs of individual patients: coordination of refills; reconciliation of medications – both prescription and over-the-counter; immunizations, such as flu shots and other adult and adolescent immunizations; blood pressure and other health tests; making sure patients understand the importance of taking their medicines correctly; prevention and wellness education; even customized programs for chronic disease management;
Pharmacists. Pharmacists are pivotal players in the health of their patients. For decades, pharmacists have been underutilized as healthcare providers. Patients typically see their pharmacists 12 to 14 times per year – more than any other practitioner. They are among the most accessible healthcare providers and are at a key intersection in health care to assist in coordination of care. This gives pharmacists the unique opportunity to assume a much more meaningful role in people’s health care. RxAlly will equip pharmacists to bring together the best of personalized care with innovative new technologies, products and services; and
Payers. With RxAlly, payers can realize better cost control and improved health outcomes for their member patients. Available to all government and commercial organizations, RxAlly plans to offer payers innovative options to design, manage and measure the clinical services that support their prescription health benefits. The RxAlly patient-centric approach, supported by clinical research, seeks to improve employee productivity and reduce healthcare costs.