US Pharm. 2007;32(5):12.
FDA Advisory Board Rejects Arthritis Drug Approval
Gaithersburg, MD --The FDA's Arthritis Drugs Advisory Committee voted overwhelmingly to reject approval of Merck's COX-2 inhibitor Arcoxia (etoricoxib). By a vote of 20 to one, the committee affirmed that the cardiovascular risks of the drug outweigh its benefits for treating arthritis pain. Despite the fact that Arcoxia is already approved in 48 countries, the comments of several board members pointed to the fact that Merck failed to convince them there was need for the drug beyond what is currently available. Merck voluntarily withdrew another COX-2 drug, rofecoxib (Vioxx), from the market in September 2004 because of studies that linked it to increased risk of cardiovascular events.
Rising Vaccine Costs Put Children at Risk
Chicago -- The American Academy of Pediatrics (AAP) is alarmed that the soaring costs of vaccines, combined with lower insurance reimbursements, will lead to underimmunization of the nation's children and unnecessary outbreaks of preventable diseases. "The system for delivering vaccines is broken, and we're going to be in real trouble if it's not fixed soon," said AAP President Jay E. Berkelhamer, MD, FAAP. Results from a national AAP survey indicated that more than half of the pediatricians surveyed think vaccine reimbursement from private and public health insurance is inadequate. This is significant because approximately 85% of children in the U.S. are vaccinated at pediatricians' offices.
CMS Exempts Diabetes Testing Products from Bidding Process
Alexandria, VA -- The National Community Pharmacists Association (NCPA) is applauding the action taken by the Centers for Medicare & Medicaid Services (CMS) in its final rule that exempts diabetes testing products from competitive bidding requirements for Medicare beneficiaries. The NCPA said CMS' action is a victory for patients and community pharmacists who opposed new federal government regulations. These regulations would have placed burdensome accreditation and competitive bidding requirements on diabetes testing supplies, which in turn would have dramatically reduced patients' access to diabetes testing devices and other health care products.
FDA Recommends Reauthorizing Medical Device User Fee Program
Rockville, MD -- The FDA has recommended that Congress reauthorize the Medical Device User Fee and Modernization Act (MDUFMA II), which, if adopted, would help ensure that safe and effective medical devices get to patients in a timely manner. Under the user fee program, industry covers a portion of the costs of FDA's premarket review program through a variety of fees. The fees are in addition to the agency's annual appropriations and represent less than a quarter of the overall device budget for MDUFMA II. "The proposal would give companies predictable fees and improved review times as well as provide FDA with a steady source of additional funding for its device review program," said FDA Commissioner Andrew C. von Eschenbach, MD.
Alzheimer's Disease Rates on the Rise
Washington -- According to the Alzheimer's Association, there are more than five million people in the U.S. living with Alzheimer's disease (AD). That represents an almost 10% increase from the previous estimate of 4.5 million. The greatest risk factor in AD is increasing age. With 78 million baby boomers beginning to turn 60 last year, it is estimated that one person will develop AD every 72 seconds; by midcentury, one person in the U.S. will develop AD every 33 seconds.
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US Pharm. 2007;32(5):12.