Emergency Contraception Issue Complicates FDA Nominee's Future

President Bush has nominated Andrew Von Eschenbach to head the Food and Drug Administration. Von Eschenbach — who's still technically also the head of the National Cancer Institute — has been leading the FDA on an acting basis since last fall. Still, his formal promotion is anything but assured.

Von Eschenbach is a Bush family friend and the former head of the MD Anderson Cancer Center in Houston. As a cancer expert, he's uniquely qualified to head the FDA, says Margaret Foti, who heads the American Association for Cancer Research.

"The science is becoming so complex, and with molecular-targeted therapies, it's increasingly important that science be integrated into the process of drug approval," she said.

But within minutes of the White House announcement, Von Eschenbach's nomination ran into a political buzz saw over something far removed from the approval of cancer drugs. After three years, the FDA still hasn't ruled on a request to allow the morning-after emergency contraceptive pill called Plan B to be sold without a doctor's prescription. Backers of that switch say that until there is ruling, there won't be a new FDA commissioner.

"This time around, we are being very firm," said Sen. Patty Murray (D-WA). "The FDA needs to follow its own rules and make a decision, yes or no on Plan B, and their credibility is at stake. We will hold up this nomination until that decision is made."

If that sounds like the same threat Murray made a year ago, that's because it is. Murray and Sen. Hillary Rodham Clinton (D-NY) together blocked Senate confirmation of then-deputy FDA Commissioner Lester Crawford for several months in 2005. They finally brokered a compromise with Health and Human Services Secretary Mike Leavitt last summer to trade Crawford's confirmation for an up-or-down decision on Plan B by September 1 — or so they thought.

"We were told, in a written letter by Secretary Leavitt, that a decision was going to be made," said Murray. "And as soon as the nomination — we said fine, make a deal, it goes through — we found out they weren't going to make a decision."

Instead, Crawford announced another delay: The agency would ask the public to comment on the question of whether to allow over-the-counter sales of Plan B to women 17 or older and prescription sales to younger teenagers. Kirsten Moore, President of the Reproductive Health Technologies Project, says that violated more than just the spirit of the deal.

"The FDA took a quote, unquote, action that we all regard as just pure political trickery by saying, 'ah, we can't rule on this application yet. We have to ask the public whether we should propose a regulatory rulemaking process," she said. "Which was a de facto indefinite delay."

The action led to the resignation of Susan Wood, the FDA's top women's health official, who said the decision was motivated by politics, not science. Some abortion opponents say Plan B — which the FDA classifies as a contraceptive — can work as a very early abortion by preventing the implantation of a fertilized egg.

Crawford announced his resignation only a few weeks later, under circumstances that still haven't been fully explained. But Moore says that as acting commissioner, Von Eschenbach has the power to make good on the original deal.

"Dr. Von Eschenbach could say at any moment, 'To restore the integrity and independence of this agency, I am going to dispense with the rulemaking and actually go along with what Crawford said on August 26, which is that the FDA has found this product safe for over-the-counter use for women 17 and older," she said.

But even if Von Eschenbach's nomination is blocked indefinitely, it will be mostly status quo for the FDA under President Bush. In the five years Bush has been in office, the agency has had a Senate-confirmed commissioner for only 18 months.

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