If you're waiting on the Obama Administration to release the contents of its budget for the 2014 fiscal year, the Office of Management and Budget (OMB), the executive office charged with formulating the President's budget, has a message for you: Wait a while longer.
As in 2012, this year's budget is running late. In a letter sent to Rep. Paul Ryan, former vice presidential candidate and chairman of the House Committee on the Budget, OMB Acting Director Jeffery Zients noted that its upcoming budget proposal still isn't done.
"For over a year and a half, the Administration has been working with Congress to forge agreement on a plan that would both grow our economy and significantly reduce the deficit," Zients wrote, adding that the administration favors a mix of both program cuts and increased revenues.
The budget is due in Congress by 4 February 2013, but Zient's letter implies it may be late as the result of overriding administrative priorities.
"As you know, the protracted 'fiscal cliff' negotiations that led to the enactment of H.R. 8, the American Taxpayer Relief Act of 2012, created considerable uncertainty about revenue and spending for 2013 and beyond," Zients continued. As a result, he said, "the Administration was forced to delay some of its FY 2014 budget preparations, which in turn will delay the budget's submission to Congress."
The government is currently operating on the latest in a series of continuing budget resolutions, which essentially fund the government as the previous year's levels with some minor changes.
Clues from the Last Budget Proposal?
The administration's last proposal called for a small increase in FDA's funding totaling $11 million, though the majority of those funds were reserved to enact the Food Safety and Modernization Act of 2011.
Even if FDA loses some funding in the new budget, it may fare better than other agencies. That's because the agency got a large boost in its funding this year under the terms of the FDA Safety and Innovation Act (FDASIA), which enhanced the user fees payable by the pharmaceutical, medical device, generic pharmaceutical and biologics industry. Another user fee bill containing the reauthorization of the Animal Drug User Fee Act is set to come up for a vote in Congress later this year and could provide opportunities to increase FDA's funding yet again.
FDA's last budget also contained a number of initiatives aimed at specific projects and programs, including regulatory science, anti-counterfeiting measures, enhanced foreign inspections, medical countermeasure initiatives and more.
In total, the budget contained more than a half billion dollars related to funding medical countermeasures, though the funding was spread across multiple agencies and in multiple forms. The Department of Health and Human Service's budget, for example, included something it called a "Strategic Investor" unit-a venture capital entity meant to develop the next generation of medical countermeasures.
The budget also contained a number of cost-cutting measures, such as reducing marketing exclusivity for biosimilars from 12 years to 7 years, an end to pay-for-delay settlement agreements between branded and generic pharmaceutical companies that critics say delays medicines, and further reduced drug reimbursement rates paid for by the Medicare Part D program.
None of those programs have yet been enacted into law, and could be in the budget proposal yet again as federal officials grapple with ways to cut the deficit. Regulatory Focus has put in a request to FDA's budget officials for more information and will provide updates if we receive any word back.