GPhA hopes Office of Generic Drugs gets more funding from Congress
ARLINGTON, Va. An organization representing the generic drug industry is hoping that Congress gives the Food and Drug Administration’s Office of Generic Drugs increased funding.
The Generic Pharmaceutical Association expressed hope that Congress would pass the Obama administration’s budget, which would give the OGD $51.5 million, $10 million more than it got last fiscal year.
“Given the critical mission of the FDA to protect the public health, it is incumbent upon Congress to provide the agency with the resources it needs to fulfill this mission,” GPhA president and CEO Kathleen Jaeger said in a statement. “There is no doubt that the FDA’s Office of Generic Drugs is severely underfunded.”
The office has hit a speed bump in recent years as its backlog of generic drug approval applications has swelled. In testimony before the Senate Agriculture Appropriations Subcommittee, FDA commissioner Margaret Hamburg said nearly 2,000 applications currently pending. Another swell of applications is on the way as patents on a number of drugs, including blockbusters such as Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) are set to expire over the next decade.
“It is unacceptable that the current review time has swelled to 26 months, nearly one and a half years longer than the six-month review period permitted under federal regulation,” Jaeger said.
Study: Dementia may be triggered by depression in diabetics
NEW YORK Diabetic adults with depression are twice as likely to develop dementia, according to a new study published in the Journal of General Internal Medicine.
To test the idea that the development of dementia — which causes progressive decline of thinking and reasoning abilities — may be caused by both factors, researchers (that included Group Health Research Institute in Seattle and the Veterans Affairs Puget Sound Health Care System) led by Wayne Katon, professor of psychiatry and behavioral sciences at the University of Washington, tracked the outcomes of adults from the Group Health Cooperative’s diabetes registry who agreed to participate.
Over the five-year period, 36 of 455 patients, or 7.9%, of the diabetes patients with major depression were diagnosed with dementia. Among the 3,382 patients with diabetes alone, 163 patients, or 4.8%, developed dementia.
The researchers calculated that major depression with diabetes was associated with a 2.7-fold increase of dementia, compared with diabetes alone. Because the onset of dementia sometimes can be marked by depression, the researchers also adjusted their hazard model to exclude patients who developed dementia in the first two years after their depression diagnosis. The team’s previous findings from earlier studies showed that depression increases the mortality rate among people with diabetes, as well as the rate of such complications as heart, blood vessel, kidney and vision problems.
“It seems prudent for clinicians to add effective screening and treatment for depression to other preventive measures such as exercise, weight control, and blood sugar control to protect against the development of cognitive deficits in patients with diabetes,” researchers said.
Grants from the National Institute of Mental Health and National Institutes of Health, supported the study.
Divine Mercy Care Pharmacy closes in D.C. area
CHANTILLY, Va. The only pro-life pharmacy in the metropolitan area of the nation’s capital is closing, according to published reports.
The Catholic News Agency reported that the Divine Mercy Care Pharmacy, in northern Virginia, was having financial difficulties and would need hundreds of thousands of dollars and would have to quintuple its customer base to stay open.
The pharmacy carried many of the same products as other pharmacies, but did not have contraceptive products, according to the CNA report. The pharmacy’s prescription records have been transferred to the local CVS store.