FDA Nominee Questioned on Emergency Contraception
Democrats on the Senate Health, Education, Labor and Pensions Committee on Tuesday during a confirmation hearing on acting FDA Commissioner Andrew von Eschenbach's nomination to permanently head the agency questioned him regarding the FDA's review of an application requesting approval for nonprescription sales of Barr Laboratories' emergency contraceptive Plan B, the Washington Post reports (Weiss, Washington Post, 8/2).
FDA in May 2004 issued a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse. Barr purchased Women's Capital during consideration of the application.
FDA in the "not approvable" letter cited inadequate data on its use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available only to girls and women ages 16 and older.
Former FDA Commissioner Lester Crawford in August 2005 opened a 60-day public comment period on the application, saying science supported approval of nonprescription Plan B access for women and girls ages 17 and older, but the application presented FDA "with many difficult and novel policy and regulatory issues," including how to enforce an age restriction.
In a July 31 letter to Barr subsidiary Duramed Research, von Eschenbach wrote that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. The letter also requested that Barr meet with FDA within seven days, make unspecified changes to the packaging for Plan B and provide a thorough description of the company's plan to enforce the age restriction (California Healthline, 8/1).
Barr spokesperson Carol Cox on Tuesday said no decision had been made between FDA and the company on when the two would meet to discuss the application.
FDA spokesperson Susan Bro on Tuesday said the agency plans to meet with Barr on Monday (Bridges, AP/Forbes, 8/1).
Von Eschenbach at the hearing said he would be open to approving nonprescription Plan B sales for women ages 18 and older, adding that approval could happen within weeks, the New York Times reports (Zernike, New York Times, 8/2).
However, Democrats on the panel "hammered" the nominee on the "timing and substance" of the letter he sent to Duramed, the AP/Forbes reports (AP/Forbes, 8/1).
Sen. Tom Harkin (D-Iowa) said, "We all know what's going on here," adding, "It's the disregard of science for ideological concerns" (New York Times, 8/2).
Von Eschenbach said that he decided to consider the application based "not on a political ideology but on a medical ideology."
Sen. Edward Kennedy (D-Mass.), the ranking Democrat on the committee said that if the letter "leads to a swift and clear decision, I applaud it." He added, "[B]ut we must make certain that the [Bush] administration does not use it as yet another delaying tactic" (AP/Forbes, 8/1).
Von Eschenbach said, "No one told me what I should or could do. No one told me what decision I must or must not make. [The letter] was my decision" (Rockoff/Beasley, Baltimore Sun, 8/2). He added that he is committed to "sound science" and candidness.
Sen. Jack Reed (D-R.I.) questioned why von Eschenbach requested a new age restriction for Barr's application. "Is there new data?" Reed asked, adding, "New analysis? Or have you just decided you don't like the conclusion of your predecessor?" (Washington Post, 8/2).
Von Eschenbach said, "It's a cut[-off] point, and you have to have some cut[-off] point" (Alonso-Zaldivar, Los Angeles Times, 8/2). He added that the age 18 limit offers a "greater safeguard in protecting and promoting the health" of young women (Pugh, McClatchy/Miami Herald, 8/1).
Von Eschenbach also said that he decided on the age limit in part because tobacco products have the same age restriction. Reed said the limit "seems ... arbitrary" (Los Angeles Times, 8/2).
Sen. Hillary Rodham Clinton (D-N.Y.), who with Sen. Patty Murray (D-Wash.) has placed a hold on von Eschenbach's nomination until FDA renders a decision on Plan B, questioned the requirement that Barr assure pharmacies are following the age restriction. She compared the condition to requiring that alcoholic beverage distillers ensure bars do not serve underage customers.
According to the Post, Republicans on the committee "generally sidestepped the Plan B fight," and all members on the panel "praised von Eschenbach's resume."
Von Eschenbach served as director of the National Cancer Institute for four years and had a long career at the University of Texas MD Anderson Cancer Center.
Some senators criticized what they say is the politicization of FDA, citing a survey released last month from the Union of Concerned Scientists (Washington Post, 8/2). The anonymous survey -- in which 997 of 5,918 FDA scientists responded -- finds that about one in six FDA scientists who participated in the survey said they have felt pressure to change the results of their work for nonscientific reasons (California Healthline, 7/21).
Sen. Barbara Mikulski (D-Md.) said the next FDA commission needs to improve on oversight of drug safety and low spirits at the agency (Baltimore Sun, 8/2).
Von Eschenbach said he opposed proposed legislation to create an independent center for drug safety within FDA but said he would emphasize drug safety. He added that he would set up means to usefully deal with scientific disagreements (Cohen, Newark Star-Ledger, 8/2).
HELP Committee Chair Mike Enzi (R-Wyo.) said he intended to vote on von Eschenbach's nomination after the Senate's August recess. "The question is not whether to confirm him. The question is whether to confirm him before Plan B is approved," Enzi said, adding, "So it's not a question of qualifications" (Baltimore Sun, 8/2).
Murray said, "There are a lot of rumors about a recess appointment" for von Eschenbach to head the agency (Anderson, Dow Jones, 8/1).
Rodham Clinton asked if von Eschenbach would accept a recess appointment from President Bush, to which he replied, "I want to look forward to the Senate's confirmation of me as your choice to be commissioner of the FDA" (Crowley, CQ Today, 8/1).
Enzi said no one in the Bush administration had discussed a recess appointment with him (Dow Jones, 8/1).
NPR's "Morning Edition" on Wednesday reported on von Eschenbach's hearing. The segment includes comments from Harkin, Mikulski and Rodham Clinton and von Eschenbach (Rovner, "Morning Edition," NPR, 8/2).
The complete segment is available online in RealPlayer. In addition, expanded NPR coverage -- including information on how Plan B works -- is available online.