VACCINE

Report of the Subcommittee on Science and Technology • November 2007
FDA Science and Mission at Risk
FDA Mission Statement
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human
and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that
emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that
make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate,
science-based information they need to use medicines and foods to improve their health.”
FINDINGS OF THE SUBCOMMITTEE
The FDA cannot fulfill its mission
because its scientific base has eroded and its scientific organizational structure is weak.
The FDA cannot fulfill its mission
because its scientific workforce does not have sufficient capacity and capability.
The FDA cannot fulfill its mission
because its information technology (IT) infrastructure is inadequate.
FDA does not have the capacity to ensure the safety of food for the nation.
The development of medical products based on “new science” cannot be adequately regulated by the FDA.
The FDA cannot provide the information infrastructure support to regulate products based on new science.
The FDA IT infrastructure is obsolete, unstable, and
lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.
There is insufficient capacity in modeling, risk assessment and analysis.
The FDA has experienced decreasing resources in the face of increasing responsibilities.
The FDA science agenda lacks a coherent structure and vision,
as well as effective coordination and prioritization.
The IT workforce is insufficient and suboptimally organized.
The FDA has an inadequate and ineffective program for scientist performance.
Recommendations of excellent FDA reviews are seldom followed.
The FDA has inadequate funding for professional development.
The FDA has not taken sufficient advantage of external and internal collaborations.
The FDA lacks the information science capability and information infrastructure
to fulfill its regulatory mandate.
The nation’s food supply is at risk. Crisis management in FDA’s two food safety centers, Center for Food
Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM), has drawn attention
and resources away from FDA’s ability to develop the science base and infrastructure needed to efficiently
support innovation in the food industry, provide effective routine surveillance, and conduct emergency
outbreak investigation activities to protect the food supply.
FDA’s inability to keep up with scientific advances means that American lives are at risk. While the world
of drug discovery and development has undergone revolutionary change — shifting from cellular to molecular
and gene-based approaches — FDA’s evaluation methods have remained largely unchanged over
the last half century. Likewise, evaluation methods have not kept pace with major advances in medical
devices and use of products in combination.
The turnover rate in FDA science staff in key scientific areas is twice that of other government agencies.
There are insufficient programs of measurement to determine worker performance. There is insufficient
investment in professional development, which means that the workforce does not keep up with scientific
advances. Finally, for various reasons, the FDA does not have sufficiently extensive collaboration
with external scientists, thus limiting infusion of new knowledge and missing opportunities to leverage
resources.
FDA’s failure to retain and motivate its workforce puts FDA’s mission at risk. Inadequately trained scientists
are generally risk-averse, and tend to give no decision, a slow decision or, even worse, the wrong
decision on regulatory approval or disapproval. During our encounters with staff and center leadership, we
were struck by the near unanimity that the shortage of science staff (due to lack of resources to hire) and
the inability to recruit and retain needed expertise are serious, longstanding challenges. Internal expertise
and experience to provide the science capability and capacity needed in highly specialized and fast-evolving
areas is disturbingly limited. The lack of a trained workforce means that the FDA is ineffective in responding
to emerging fields that require individuals and work teams with multidisciplinary skills built on
very complex, highly specialized, often esoteric bodies of knowledge.
The Subcommittee was extremely disturbed at the state of the FDA IT infrastructure .. the IT workforce
is insufficient. The IT situation at FDA is problematic at best — and at worst it is dangerous. Many of the
FDA systems reside on technology that has been in service beyond the usual life cycle. Systems fail frequently,
and even email systems are unstable — most recently during an E.coli food contamination investigation.
More importantly, reports of product dangers are not rapidly compared and analyzed, inspectors’
reports are still hand written and slow to work their way through the compliance system, and the system
for managing imported products cannot communicate with Customs and other government systems (and
often miss significant product arrivals because the system cannot even distinguish, for example, between
road salt and table salt).
There are inadequate emergency backup systems in place: recent system failures have resulted in loss
of FDA data. Critical data reside in large warehouses sequestered in piles and piles of paper documents.
There is no backup of these records, which include valuable clinical trial data. The FDA has inadequate
extramural funding programs and collaborations to accelerate the development of critical health information
exchanges in order to support clinical trials and pharmacovigilance activities.
In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent
events and our findings indicate that some of those crises are now realities and American lives are at risk.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf