US Pharm. 2007;32(5):12.
FDA Advisory Board Rejects Arthritis Drug Approval
--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
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'
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.
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
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
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