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Warning over FDA’s “science crisis”


A loss of scientific expertise is damaging the Food and Drug Administration (FDA), and in turn threatening American lives, according to a new report.

The claims have been made after scientists from leading universities and industries that the FDA regulates carried out a review of the agency over the past year.

There have been growing concerns about the FDA’s ability to safeguard the public, and the new report is the latest to conclude the cash-strapped agency has trouble keeping pace with the £483bn of consumer goods it regulates.

The report was published after FDA commissioner Andrew von Eschenbach suggested that the agency’s science board, his own outside advisers, look into the problems.

The science board subcommittee’s report said: “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.”

Since 1988, Congress has enacted 125 statutes that gave the FDA new or expanded responsibilities without providing enough money to cover the extra work, the report said. The FDA has about the same number of employees today as 15 years ago, and its budget has lost the equivalent of £144m to inflation.

At the same time, increasingly sophisticated scientific expertise is required to oversee complex medical therapies and imported foods. However, the report found the FDA is unable to recruit and retain leading-edge scientists in vital areas, with a turnover rate twice that of other government agencies.

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Food and Drug Administration

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