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At the FDA-industry interface, how close is too close? When Andrew von Eschenbach is finally confirmed by the U.S. Senate as the FDA's commissioner, it will be the result of one drug firm executive's decision. Barr Pharmaceuticals CEO Bruce Downey found himself in that position when forced to weigh the profitability of an OTC version of his emergency contraceptive Plan B against the cost of complying with the FDA's demand that his company be responsible for ensuring the product isn't sold to people under age 18.

If Downey had said, “Sorry, but no, the numbers are against this,” von Eschenbach's confirmation could be kept from a Senate vote under a political “hold” placed by Hillary Clinton (D-NY) and Patty Murray (D-WA), awaiting an FDA decision. If “Yes,” the FDA would approve Barr's form and von Eschenbach could be confirmed.

This deal-making process arose through von Eschenbach's making public a letter he'd written Downey's company before his Senate confirmation hearing, saying that the company's agreement to enforce the OTC sales age limit would help the FDA proceed further.

The Senate hearing was contentious on this tactic. Democrats said they'd never seen its like, and Clinton compared it to requiring distillers to be responsible for bars selling alcohol to under-age drinkers.

Of course, if Downey refused to forego those under-18 sales, von Eschenbach could deny the application.

As background, a New York federal lawsuit to force age-unrestricted sales was moving rapidly and could make the FDA-Barr deal moot or override it. And the 2006 mid-term elections were looming unfavorably for the White House.

However, Downey's “yes” resolved it, and for that von Eschenbach may be forever grateful.

Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)

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