Public safety at risk from FDA's lack of resources to keep up with
17 December 2007
A new report on the state of the US Food and Drug Agency (FDA) says that
the safety of the nation is at risk from the inability of the Agency to keep
up with advances across a wide range of scientific fields.
The report, FDA Science and Mission at Risk(1), produced by the
Subcommittee on Science and Technology of the FDA Science Board, attributes
the deficiencies to soaring demands on the FDA and resources that have not
increased in proportion to those demands. They conclude that "this imbalance
is imposing a significant risk to the integrity of the food, drug, cosmetic
and device regulatory system, and hence the safety of the public."
The result of a year-long review by a distinguished panel of experts, the
Subcommittee's 300-page report concludes that the state of FDA's scientific
and regulatory programs could not be separated from the lack of resources.
It urged funds to support the agency's scientific base, hire a
broadly-capable scientific workforce, and build a sophisticated, modern
information technology infrastructure.
The Subcommittee identified eight emerging sciences and technologies that
are developing at an exponential rate and are most challenging the FDA:
- systems biology (including panomics);
- wireless healthcare devices;
- medical imaging;
- robotics, cell- and tissue-based products;
- regenerative medicine, and
- combination products.
Each of these generates novel scientific, analytic, laboratory and/or
In the information field, the Subcommittee says that it was "extremely
disturbed at the state of the FDA IT infrastructure". The report says that
the FDA "has insufficient access to data and cannot effectively regulate
products based on new science due to lack of a supportive IT infrastructure"
which is "obsolete, unstable, and lacks sufficient controls to ensure
continuity of operations or to provide effective disaster recovery
Incredibly, critical data is still recorded on paper documents stored in
large warehouses. There is no backup of these records, which include
valuable clinical trials data. 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.
The Subcommittee says that "countries around the world have historically
looked to the FDA for guidance on sound, science-based regulation", but that
"today, not only can the Agency not lead, it cannot even keep up with the
advances in science".
1. Subcommittee on Science and Technology. FDA Science and Mission at
Risk. November, 2007. Prepared for the FDA Science Board. Available
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