The Alliance for a Stronger FDA has expressed disappointment that President Obama’s FY 15 budget request for FDA falls short of what the agency needs to fulfill its responsibilities.
US President Barack Obama outlined his proposed budget for 2015 earlier this week , setting out how much money he thinks will be needed to fund operation of Government departments and programmes for the next 12-months.
For the US Food and Drug Administration (FDA) President Obama has requested $2.586bn (EUR1.883bn), which is an increase of just $25m, or 1%, on the funding the agency received in fiscal 2014.
This small requested increase disappointed the Alliance for a Stronger FDA. The advocacy group, whose almost 200 members represent a cross-section of FDA stakeholders, said that instead “substantial increases are needed to support FDA’s critical mission.”
"In this time of continuing deficit reduction pressures, we understand the difficult fiscal environment under which the White House is operating” said Kasey Thompson, president of the Alliance and Vice President, Office of Policy, Planning and Communications at the American Society of Health-System Pharmacists (ASHP).
He continued: "This budget proposal would actually weaken the FDA in certain areas, which we think the American people will regard as unacceptable. FDA's funding needs to be increased further—well above the FY 14 level--to reflect the agency's vast public health responsibilities and continually increasing workload.
Thompson warned that: “If the FDA does not have the resources to fulfill its mission, there is no other Federal, state or private agency that provides a fall back.”
“We’re concerned about drugs, biologics, devices, whether there will be delays in implementing FDAsia,” Steven Grossman, a spokesman for the Alliance told in-Pharmatechnologist.com.
“I’m afraid the FDA is going to try and cover itself as best as they can. I don’t know where the holes will be – might be slowing in compounding security, slowdown of biosimilars, it’s hard to tell.”
In the short break down of the budget request , the Alliance says that $210m has been allocated for oversight of biologics $210m, which is much less than the $285m set aside for rent and facility related costs.
Grossman told us that the “FDA is very people-attendant, unlike say an NIH, but the product is the product of people – most of the cost of the agency is salary and providing for the needs of a productive worker.”
Under the President’s budget request, drugs (CDER + CBER) would grow about 2% and the rest of FDA would lose about 1.5%, including a $3m decrease for device programs.
"Alliance members remain committed to assuring that FDA is adequately funded," said Jeff Allen, PhD, VP of the Alliance and Executive Director of the Friends of Cancer Research.
A more detailed budget is coming next Tuesday.