FDA Commish chided over import safety

FDA Commissioner Andy von Eschenbach [1] found himself in the hot seat again at a Congressional hearing. The House Committee on Energy and Commerce grilled the agency chief about foreign oversight and scolded him for safety lapses that occurred on his watch, including the big heparin debacle that's been unfolding since January. "You presided over this," Dingell said.

The committee wasn't happy with von Eschenbach's overhaul plan [2], either. And they didn't mince words about it. The GAO had appeared at the hearing earlier, estimating that it would cost $16 million to inspect only the Chinese exporters who hadn't yet seen FDA scrutiny, and $67 million to look at exporters worldwide. But when the commissioner skittered around the numbers himself, Dingell accused him of "toe dancing," saying, "I didn't fall off the cabbage wagon yesterday." (Even more colorfully, a Republican committee member from Texas said drug makers need to be held accountable for supply chain problems, "lest we get a bucket of chicken wings with plutonium in them.")

Dingell, you'll recall, released a draft plan for foreign oversight [3], and this hearing was supposed to gather fodder for the final bill he and his co-sponsors plan to enter. It looks as if the committee got some hard info from the GAO. It also got a few suggestions from von Eschenbach, namely, that FDA needs to hire contractors and/or depend on foreign regulators to certify foreign drug companies. And upon much pressing from Dingell, von Eschenbach coughed up some inspection figures for drugs: 3,000 facilities times $45,000 per, or $70 million on a biennial inspection schedule. How will this change Dingell's bill? We'll have to wait and see.

- see the Chicago Tribune story [4]
- check out the New York Times article [5]
- find a transcript [6] of a few Dingell-von Eschenbach exchanges at In Vivo

Related Articles:
Dems pitch big safety bill [3]
Eschenbach offers 'Andy's Take' on FDA issues [1]
FDA wants satellite offices overseas [7]
Planning for the FDA's overhaul [2]
Origin labeling a sticky pharma problem [8]