Public safety at risk from FDA's lack of resources to keep up with scientific advances

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;
  • nanotechnology;
  • medical imaging;
  • robotics, cell- and tissue-based products;
  • regenerative medicine, and
  • combination products.

Each of these generates novel scientific, analytic, laboratory and/or information requirements.

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 services". 

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 from: www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html (accessed 17-12-2007).

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