Senate Democrats Question New FDA Requirements For Nonprescription Plan B Application At Von Eschenbach Confirmation Hearing

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. The letter says, "If after our discussions we conclude (your) program isn't sufficiently rigorous ... Plan B will remain [prescription]-only for women of all ages" (Kaiser Daily Women's Health Policy Report, 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 Monday (Bridges, AP/Forbes, 8/1).

Plan B Comments at Hearing
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). "We all know what's going on here," Sen. Tom Harkin (D-Iowa) said, 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." If the letter "leads to a swift and clear decision, I applaud it," Sen. Edward Kennedy (D-Mass.), the ranking Democrat on the committee said, adding, "[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.

Age Limit, Enforcement Requirements Questioned
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.

Outlook for Nomination
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 (Kaiser Daily Health Policy Report, 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 Newswires, 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 Newswires, 8/1).

Related Editorials

• Boston Globe: Because Plan B prevents pregnancy, it "should be available without a prescription to women of all ages, [b]ut even sales to older women would represent progress," a Globe editorial says. Until nonprescription sales of Plan B to women ages 18 and older is approved, "senators should keep von Eschenbach's confirmation on hold," the editorial concludes (Boston Globe, 8/2).
  


• New York Times: "[S]keptical Democratic senators are right to threaten to block a confirmation vote" on von Eschenbach until the agency makes a decision on nonprescription sales of Plan B, a Times editorial says. Although a hold on von Eschenbach's confirmation could be circumvented with a recess appointment by President Bush, if von Eschenbach wants to be the "Senate's choice, not just the president's, he would be wise to ask Mr. Bush to let the process move forward," the editorial concludes (New York Times, 8/2).
  


• USA Today: While FDA's "proposed compromise" to consider allowing nonprescription access of Plan B to women ages 18 and older is an "important step forward," it continues to "fal[l] short on science and sensible policy" because it would not help prevent unintended pregnancy and abortion among girls under age 18, a USA Today editorial says. In addition, FDA "warned Barr ... that unless it provides details on how the age restriction would be rigorously enforced at pharmacies," the pill will remain available only by prescription, the editorial says, concluding that this "[s]ounds like a potential excuse to reject Plan B -- after von Eschenbach is confirmed" (USA Today, 8/2).

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.

Nine Washington State Women File Complaints About Lack of Access to Plan B
In related news, nine women in Washington state on Monday filed complaints with the state Board of Pharmacy alleging that four pharmacies failed to carry or stock EC despite a state regulation that requires them to fill such prescriptions, the AP/Seattle Post-Intelligencer reports. The women said they were unable to receive 17 prescriptions for EC at four pharmacies in June and July. According to Steven Saxe, executive director of the state pharmacy board, a three-member panel of the board has 21 days to decide whether to take further action on the complaints or to dismiss them. If action is taken, investigators will have 170 days to issue recommendations for review, after which a panel of three board members will issue formal charges and seek fines or other penalties, the AP/Post-Intelligencer reports (AP/Seattle Post-Intelligencer, 8/1).

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