FDA seeks budget increase from Obama administration
ROCKVILLE, Md. The Food and Drug Administration hopes to “transform” its oversight of medical product and food safety with a request of $4.03 billion of the Obama administration’s fiscal year 2011 budget, the agency announced Monday.
The request, which covers the period from Oct. 1, 2010 through Sept. 30, 2011 and represents a 23% increase over its fiscal year 2010 budget, includes a $146 million increase in budget authority and $601 million in industry user fees. A further $51.5 million will go to the Office of Generic Drugs, $10 million more than the office got for fiscal year 2010.
With the extra money, the agency hopes to focus on prevention, increased efforts to address medical product safety challenges and modernization of regulatory science.
Of the new budget, $100.8 million will go toward the Protecting Patients Initiative to protect the safety of drugs, vaccines, medical devices and donated blood. The biggest portion, $318.3 million, would go toward enhancements of food-safety oversight, while $215 million would go toward regulating tobacco products, which the agency began doing in July 2009. Another $25 million will expand the FDA’s scientific capacity and allow it to identify “improved pathways” to product development and approval.
“The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans thorugh every stage of life, many times a day,” FDA commissioner Margaret Hamburg said. “This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”
The proposal also includes a system of user fees for generic drugs companies that published reports said would raise about $38 million. In a statement Monday, Generic Pharmaceutical Association president and CEO Kathleen Jaeger said the organization was open to user fees and hoped to develop a program with “measurable results.”
In related news, the National Community Pharmacists Association responded to the Obama administration’s budget proposal, stating that “the President’s budget proposal is the ‘starting gun’ of what will be a marathon-like process to determine the government’s spending and policy priorities for fiscal year 2011,” adding that they are “still reviewing the wide-ranging proposal” and looks forward to working with the Administration and both parties in Congress on these and other proposals throughout the budget process.”
Lupin receives FDA approval for hypertension generic
BALTIMORE The Food and Drug Administration has given approval to a generic version of a drug used to treat high blood pressure made by an Indian drug maker.
Lupin Pharmaceuticals announced Thursday that it had received approval for perindopril erbumine tablets, used to treat essential hypertension and management of coronary artery disease.
The drug is a generic version of Solvay Pharmaceuticals’ Aceon, which had sales of $24 million during the 12-month period ending in September 2009, according to IMS Health.
Loose ends should be tied to make e-prescribing a reality
WHAT IT MEANS AND WHY IT’S IMPORTANT Relative to the national chains, independent pharmacies have limited resources and, given the importance and benefit of e-prescribing, further helping to facilitate the adoption of e-prescribing via grants — not to mention facilitating two-way communication between prescribers and pharmacists — is critical to help push overall adoption closer to the finish line.
THE NEWS: (NCPA: E-prescribing should be more efficient in two-way communication, cost. For the full story, click here)
As stated in the article, the National Community Pharmacists Association, at a recent e-prescribing committee, recommended providing grants to offset implementation and transaction fee costs and making two-way communication between prescribers and pharmacists easier.
In written testimony at a hearing of the Department of Health and Human Services’ Health Information Technology Policy Committee Information Exchange Workgroup, the NCPA acknowledged that community pharmacists have a vested interest in making e-prescribing work but yet cost challenges remain.
E-prescribing has been praised especially in recent years as it has been shown to increase the likelihood that patients will get their prescriptions filled and, in turn, avoid more expensive medical procedures. There’s also less of a chance for errors compared with paper prescriptions.
E-prescribing has achieved impressive milestones in recent years but the journey is far from over. In October 2009, e-prescribing network provider Surescripts announced that 23% of all office-based physicians, nurse practitioners and physician assistants in the United States are now e-prescribing. At that rate, Surescripts projected that its total number of active e-prescribers in 2009 would more than double the 74,000 active e-prescribers at the end of 2008.