GDUFA Commitments Won’t Be Met If Congress Nixes White Oak Funding
Executive Summary
President Obama’s FY 2014 budget proposal argues that Congressional failure to provide FDA with additional funding for its White Oak consolidation efforts could force GDUFA hiring to stall, jeopardizing the agency’s ability to meet the user fee commitments negotiated with industry.
President Obama’s FY 2014 budget warns that FDA will not meet its generic drug user fee program commitments if Congress fails to provide the additional $17.9 million in appropriations to complete consolidation efforts at its White Oak headquarters in Silver Spring, Md.
The budget proposal requests $61.9 million in funding for White Oak consolidation efforts, up from $44 million in FY 2012. Nearly all ($17.7 million or 99%) of the increase needed to complete the Life Sciences-Biodefense Laboratory Complex (LSBC) and the expansion of the vivarium (transparent enclosure for small animal observation) will come from new budget authority, while just $283,000 will come from user fees. The LSBC is a four building complex that includes White Oak’s two largest laboratories (building 52 and 72) and two office buildings (buildings 71 and 75).
The additional funding is needed early in the upcoming fiscal year to ensure the LSBC is operational and ready for occupancy in the spring of 2014, FDA says in its budget documents. Without an operational complex, the agency says it won’t be able to hire necessary staff funded by GDUFA as it will not have a location for them, impacting its ability to meet the new user fee program’s goals. The agency could not elaborate on specific GDUFA commitments that would be affected, citing simply “general implementation,” of the program.
The agency has set aggressive hiring goals to allow it to meet many of the commitments outlined in the GDUFA agreement with industry, such as shortening the time for abbreviated new drug application approvals and increasing the frequency of facility inspections, particularly foreign inspections (Also see "GDUFA Performance Goals For Fiscal Years 2013-2017" - Pink Sheet, 12 Dec, 2011.).
FDA estimates the five-year program will require 950 additional staff members, and it committed to hiring half of those in FY 2014 (Also see "GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm" - Pink Sheet, 17 Dec, 2012.). The FY 2014 budget request anticipates 690 full time equivalents working due to generic drug user fees. CDER, which receives the bulk of GDUFA funding, anticipates hiring 194 new full time equivalents with user fees in FY 2014, compared to 250 new hires in FY 2013.
Second Time’s The Charm?
FDA’s push for additional monies for the White Oak consolidation comes after such requests faltered in FY 2013. The continuing resolution under which the federal government has been operating this year has left White Oak consolidation activities with $44.3 million, just $300,000 more than FY 2012 despite FDA’s request for $61.7 million for the project in 2013 (Also see "Revising The Blueprint: FDA HQ Construction Nears Completion, But Some Planned Buildings On Hold" - Pink Sheet, 20 Feb, 2012.).
In FY 2014, new budget authority for White Oak accounts for FDA’s second largest chunk of new tax dollars, trumped only by the agency’s request for $43.4 million in new public monies for food safety. FDA outlines $84 million in new budget authority for FY 2014, but anticipates receiving only $52 million in additional funding. This means other programs, including the human drugs program, will take cuts in federal funding in what Commissioner Margaret Hamburg has dubbed an “austere budget” year that leaves the agency increasingly reliant on user fees (see related story, (Also see "FDA’s Budget Proposal: It’s The User Fees’ Agency Now" - Pink Sheet, 15 Apr, 2013.)).
The agency’s appeal for new White Oak funds says LSBC is a key component of the agency’s regulatory mission that will enable FDA to conduct the research needed to support medical product innovation.
The FY 2014 funds will be used to support the outfitting and required certification and operation of the LSBC and the expansion of the vivarium, including installation, testing, commissioning and functioning of specialized equipment; building automation operation and monitoring; HEPA filter tests; air sensors; primary bio-containment device effectiveness; and room pressurization control and power tests.
Besides GDUFA initiatives, FDA says critical CBER and CDER programs such as annual and pandemic influenza, medical countermeasures, blood and other biologic products and biosimilars will take a “severe blow” without an operational LSBC. The complex is nearly complete, but unusable according to the agency. In the interim, FDA is forced to pay double rent for its existing CBER and CDER space and the LSBC. FDA and the General Services Administration have already spent $300 million in construction and related costs for the buildings.
FDA’s regulatory science efforts will also take a critical hit without the needed White Oak consolidation funding as the agency will not keep pace with current technological and scientific advances, adversely affecting the introduction of safe and effective medical products and the agency’s ability to keep pace with emerging threats, FDA says. CBER’s 2012-2016 Strategic Plan for Regulatory Science and Research highlights the new complex and the new technology that will allow for improvements in areas such as genomics, post-marketing surveillance of large databases and clinical trials (Also see "CBER Strategic Plan Showcases New Lab Complex, Research Projects For Cancer, Rare Diseases" - Pink Sheet, 4 Jun, 2012.).
Critical CBER and CDER operations are currently housed in outdated laboratory and office space, the agency says. “Part of advancing regulatory science is investing in new technology to enable FDA to function as a 21st century regulatory agency … FDA laboratories must be maintained and updated in a manner that is consistent with the work FDA is entrusted to do. FDA cannot afford to lose ground in the technological revolution and must keep up or stay ahead,” the agency argues.