Medical Device Daily Washington Editor

WASHINGTON – Yesterday's confirmation hearing for Andrew von Eschenbach to head the FDA never approached an actual vote, serving instead as a Q&A session on the controversial abortifacient known as “Plan B,” manufactured by Barr Labs (Pomona, New York), its delayed approval thus far being the main obstacle to von Eschenbach's approval.

On Friday, the FDA issued a statement offering an alternate to Barr's initial and amended applications. The agency said that it would examine the idea of over-the-counter (OTC) sales for anyone aged 18 and over, but the concession apparently failed to mollify Senate Democrats, who blasted von Eschenbach – and the agency – for not offering to make the drug available to minors without a doctor's order.

The health committee chairman, Sen. Michael Enzi (R-Wyoming) told von Eschenbach, “I've been impressed with your dedication to solving problems,” and he lamented that the agency “has been without a commissioner for all but 18 months in the last five years.”

And he urged his colleagues “to consider” the impact of the leadership dilemma at the agency on its ability to carry out its mission.

And Democrats were equally willing to validate von Eschenbach's record as a physician or public servant.

Ted Kennedy (D-Massachusetts) told him: “I've always admired your leadership” at the National Cancer Institute (Bethesda, Maryland).But Kennedy expressed concern that many who work at the agency feel that they are under “unfair pressure to ignore science” in favor of political theory.

Regarding the confirmation exercise, he said, “if this step leads to a clear decision [on Plan B], I applaud it.”

Kennedy also opined that the FDA “is perhaps the most important health agency in the U.S. and probably the world.” But, he said, “this agency is really in trouble,” in part because of “inadequate resources.”

Sen. Kay Bailey Hutchinson (R-Texas) offered a formal introduction of the acting FDA director, calling him “the highly qualified person we're looking for” to lead the agency, and she seconded Kennedy's comment concerning the FDA's top position as a U.S. healthcare agency. She described von Eschenbach's credentials as impeccable and said that “I think it is important that we have Senate confirmation.”

“I am acutely aware of the agency's need for strong leadership,” von Eschenbach said, adding that his role as the FDA chief would be to earn the “trust of patients and the public that our every single action, decision or activity is directed to preserving their lives and protecting their health.”

He said that one of the problems encountered with Plan B – which apparently has fed into the drawn-out approval timeline – was how the agency might approach a scenario in which the drug is available as both a prescription and an OTC product. He noted that the FDA's call for public comment on this topic generated more than 47,000 responses.

As for questions of safety and efficacy related to the original application, which sought OTC status for girls 16 and younger, von Eschenbach said that while the overall data set suggested that Plan B is both safe and effective, “the data did not apply equally to all subsets” of the population studied by Barr's clinical trials.

The agency's decision to approach Barr on an 18-and-over approval is based on “issues related to age,” including the ability of users to interpret instructions and properly use Plan B.

Barbara Mikulski (D-Maryland) lambasted the agency for “a crisis in morale, a crisis in confidence,” asking the candidate for assurance that von Eschenbach would not “politicize” the agency.

Von Eschenbach replied that he is working on a plan, including an ombudsman function, that would “facilitate vigorous scientific debate” as his first priority. He also noted that a “back channel” for complaints “parallel with the experience I've had” would be part of the program at the FDA.

However, he also said that interpretation is part of the agency's use of scientific data, and the fact that not all are in agreement on a given interpretation does not make decisions based on those interpretations necessarily wrong.

Mikulski asked about developing a new, external drug safety board, but von Eschenbach replied he believed this could be accomplished with the current authority to establish safety.

Mikulski replied: “I don't know if FDA is capable of having an effective board within itself” to ensure safety.

Sen. Patty Murray (D-Washington) – who rarely allowed von Eschenbach to finish answers to her questions – charged that FDA is in a state of “deep crisis” due to a lack of predictability” on questions of safety and efficacy.

“Plan B is symbolic of peoples' crisis of confidence” in the agency, she said. She suggested the prospect of a filibuster on the nomination by commenting that “it is important to have these questions about Plan B behind us so that we can vote.”

She also asked Enzi if von Eschenbach would move into the FDA director's position via a recess appointment. Enzi replied that he did not make such decisions and that he was not part of any discussions on that issue.

After the hearing, Enzi indicated that he assumed that the nomination would go through sooner or later. “It's not a question of whether he will be confirmed [by the committee], but whether he will be confirmed before or after the Plan B decision,” he said.

In a July 27 letter to Enzi, Mark Leahey, president of the Medical Device Manufacturers Association (Washington), offered “strong support for the speedy confirmation” of von Eschenbach, which he said “is critical to ensuring the public health and safety of the nation's citizens.”

Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America (Washington), in a statement issued yesterday, took no stand on whether Plan B should hold up von Eschenbach's nomination. But the statement said that “a permanent commissioner speaks with greater authority about the resource needs” of the agency and “is more apt to be focused on long-term programs, policies and strategic thinking.”

Lost in yesterday's hearing was another confirmation Q&A, this one for Paul DeCamp as the wage and hour administrator at the Department of Labor, whose nomination also fell into the August dead zone.

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