MedImmune applies to market FluMist in Europe
NIJMEGEN, Netherlands AstraZeneca’s biologics unit has submitted an approval application to market its FluMist nasal spray in Europe.
MedImmune announced Tuesday that it had submitted its application to the European Medicines Agency as a vaccine against seasonal influenza, following results from 73 clinical and post-marketing studies on more than 141,000 subjects in 38 countries.
“Influenza creates a heavy medical and economic burden on Europe and throughout the world, and we are hopeful that the future availability and product characteristics of this novel nasal spray influenza vaccine will contribute to an increase in vaccination rates and reduce the spread of influenza around the world,” MedImmune EVP for clinical affairs and CMO Alex Zukiwski said in a statement.
American Idol judge teams with AHA to promote diabetes awareness
PHILADELPHIA Music industry veteran and TV personality Randy Jackson (American Idol) will be teaming up with the American Heart Association for a second year to help people living with Type 2 diabetes understand the importance of properly managing their disease, and to encourage them to enroll in The Heart of Diabetes campaign on Jan. 8, the American Heart Association announced Tuesday.
Jackson, who lives with type 2 diabetes, is coming to Philadelphia to urge adults in the city with diabetes to get regular physical activity, make healthy food choices and work with their healthcare providers to develop a comprehensive treatment plan.
In addition, local chef Delilah Winder will host a free cooking demonstration to show how lifestyle changes, such as eating a healthy, well-balanced diet, can help individuals improve their management of Type 2 diabetes.
NACDS challenges report on DME rules
ALEXANDRIA, Va. Hitting back against what it argues is inadequate or biased coverage of a health care issue of concern to its members, the National Association of Chain Drug Stores today took the Wall Street Journal to task for a report on federal regulations for providers of durable medical equipment and supplies for Medicare beneficiaries.
The organization swung into action via its NACDS Rapid Response program in response to a recent Wall Street Journal Health Blog post. The posted article, NACDS president and chief executive Steven Anderson asserted today, correctly cited the need to combat Medicare fraud but ignored the harmful impact the new DME regulations would have on pharmacies.
Through the Department of Health & Human Services, the Bush Administration pushed through new rules established by the Centers for Medicare & Medicaid Services, for the sale of DME in retail outlets. Under the new regulations, retailers wishing to participate in the market for durable medical equipment will be required to gain accreditation to sell home health and other health supplies, and to bid in competition with other DME providers to obtain contracts to sell those products. The so-called Competitive Acquisition Program was originally launched in 10 markets as a demonstration project, with delayed plans for a phased national rollout.
NACDS and other pharmacy groups were instrumental in securing that delay through legislation to postpone and reform Medicare’s competitive bidding program for DME. The group reports it is now “engaged with Congress and CMS to ensure that policies intended to safeguard the Medicare program are implemented in a manner that minimizes disruption of care.”
Responding to the WSJ article, Anderson called attention to the importance of preserving patient access to medical equipment and supplies, such as diabetes testing products. The accreditation requirement and the recently issued rule requiring that pharmacy retailers be bonded to retain Medicare enrollment, said Anderson, “are unnecessary regulations imposed on state-licensed pharmacies that could limit patients’ ability to manage their diseases.
“While it is important to stop fraudulent claims and fly-by-night operations, CMS’ new regulations will make it much harder—even prohibitive—for legitimate suppliers to provide DME for patients,” added NACDS’ top executive. “Pharmacies play a crucial role in the management of diabetes and are an essential provider of diabetic supplies and Medicare Part B medications. These regulations will threaten patients’ access to the crucial supplies and equipment to manage their diseases effectively.”