GOP lawmaker looks to limit state drug, device inspections

Rep. Brian Bilbray (R-Calif.) this week introduced legislation that would prevent any state from requiring drug or medical device inspections that are duplicative to inspections already required at the federal level by the U.S. Food and Drug Administration (FDA).

Bilbray said his bill, the Science and Technology Regulatory Relief Act, is needed in his state because the California Food and Drug Branch is now running inspections that are mostly similar to FDA inspections, which he said is hurting job creation.

"The path to economic recovery begins with reining in senseless regulations placed on business," Bilbray said. "This additional inspection not only costs companies hundreds of thousands of dollars, but it diverts limited time and resources away from research, development and innovation.

"As a global leader in the advanced life sciences industry, San Diego is disproportionately affected by this unnecessary and costly state regulation," he added. "With nearly one in 10 San Diegans out of work, our advanced life sciences industry is one of the high points in the down economy, accounting for more than 24,000 high-paying jobs in our region alone."

The bill, H.R. 4056, would amend the Food, Drug and Cosmetic Act so that duplicative state-level inspections would be eliminated. But it would allow state agencies to conduct facility inspections when a drug or device is thought to pose a threat to public safety, when the federal government orders a recall of a product or if the FDA requests it.

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