Sen. Murray caves on FDA Investigation Amendment (Sen. Coburn calls her bluff)

Kaiser Foundation ^ | 11.5.05

[victim soul]

Sen. Murray Withdraws FDA Investigation Amendment After Sen. Coburn Threatens Amendment Looking Into FDA Approval of Mifepristone

Sen. Patty Murray (D-Wash.) on Oct. 26 proposed an amendment to the Labor-HHS appropriations bill (HR 3010) that would have mandated an investigation into alleged mismanagement at FDA -- including the agency's handling of a proposal to make the emergency contraceptive Plan B available without a prescription -- but later withdrew the amendment because Sen. Tom Coburn (R-Okla.) would have introduced an amendment calling for an investigation into the agency's approval of mifepristone, FDA Week reports (FDA Week, 11/4).

Murray's amendment would have shifted $3 million from the Office of the HHS Secretary to the agency's Office of Inspector General to conduct an investigation into alleged mismanagement at FDA, including its delayed decision on Barr Laboratories' application to make nonprescription Plan B available to women ages 17 and older (Murray release, 10/26).

Former FDA Commissioner Lester Crawford in August announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it, which expired on Nov. 1 (Kaiser Daily Women's Health Policy Report, 11/2).

When Murray offered her amendment, Coburn, who opposes nonprescription access to Plan B, said he would offer a secondary amendment to fund an OIG investigation into FDA's 2000 approval of mifepristone, which is used to induce medical abortion (Mundy, Seattle Times, 11/7).

FDA approved mifepristone under a set of FDA rules known as subpart H, which usually is reserved for approving drugs for life-threatening illnesses. A spokesperson for Coburn said that Murray then withdrew her amendment because both it and Coburn's secondary amendment immediately would have come to a vote.

A spokesperson for Murray denied that assertion, saying that neither amendment would have reached a vote because they asked for new investigations, which should be introduced into legislation, not through an appropriations bill (FDA Week, 11/4).

Friday, November 04, 2005

National Politics & Policy

House Lawmakers Introduce Bill That Would Allow Sales of Nonprescription Plan B Until FDA Decides on Barr's Application http://www.kaisernetwork.org/daily_reports/rep_women_recent_reports.cfm?dr_cat=2&show=yes&dr_DateTime=04-Nov-05

Four members of Congress on Thursday introduced a bill in the House that would allow the nonprescription sale of Barr Laboratories' emergency contraceptive Plan B until FDA decides on Barr's application to sell the pills without a prescription to women ages 17 and older, Reuters reports. The measure -- which is sponsored by Reps. Carolyn Maloney (D-N.Y.), Christopher Shays (R-Conn.), Joseph Crowley (D-N.Y.) and Jay Inslee (D-Wash.) -- would force automatic approval of nonprescription Plan B 30 days after the bill is approved until FDA makes a decision on Barr's application (Heavey, Reuters, 11/3).

The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription, citing inadequate data on Plan B use among girls under age 16. Barr then submitted an application that would allow Plan B to be sold without a doctor's prescription only to women ages 17 and older. Former FDA Commissioner Lester Crawford in August announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it, which expired on Tuesday. Up to 10,000 comments were submitted during the comment period (Kaiser Daily Women's Health Policy Report, 11/2).

Reaction "It's become clear that FDA's refusal to make [Plan B] available over the counter is a political decision," Maloney said, adding, "Either approve it or make a decision" (United Press International, 11/3).

Crowley said, "[W]e ask simply for an end to this charade" (Crowley release, 11/3).

Planned Parenthood Federation of America Interim President Karen Pearl praised the bill, saying, "The time has come [for FDA] to quit stalling and live up to its mission of protecting the public's health and well-being," adding, "Emergency contraception has been proven safe and effective, and the FDA's own advisory panels overwhelmingly approved over-the-counter status for Plan B emergency contraception" (PPFA release, 11/3).

Gene Rudd, associate executive director of the Christian Medical & Dental Associations, said that allowing women to bypass a health care provider to obtain EC could be harmful to their health, according to Family News in Focus, a Web site of Focus on the Family. "They're going to be removed from the very system that's going to give them the best health care," Rudd said, adding, "That's just not good public health policy" (Trobee, Family News in Focus, 11/4).

Comment Period on Application for Nonprescription Plan B Ends; FDA Does Not Indicate Plan for Action on Application [Nov 02, 2005] http://www.kaisernetwork.org/daily_reports/rep_women_recent_reports.cfm?dr_cat=2&show=yes&dr_DateTime=02-Nov-05 The 60-day public comment period on whether to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B expired on Tuesday with up to 10,000 comments submitted to FDA, the Washington Post reports. FDA spokesperson Julie Zawisza said the agency will review the comments "and decide how to proceed," but the agency did not indicate when it might make a decision (Kaufman, Washington Post, 11/2). FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription, citing inadequate data on Plan B use among girls under age 16. Barr submitted another application that would allow Plan B to be sold without a doctor's prescription only to women ages 17 and older. Former FDA Commissioner Lester Crawford in August announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it (Kaiser Daily Women's Health Policy Report, 10/14). Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) on Tuesday submitted a petition signed by more than 9,800 supporters to acting FDA Commissioner Andrew von Eschenbach, saying the agency's delayed decision is "virtually unprecedented." Murray urged the agency to make its decision "based on science and efficacy, not on public pressure" (Lumpkin, AP/San Francisco Chronicle, 11/1). In addition, a coalition of 48 public health and medical organizations, including the American College of Obstetricians and Gynecologists, on Tuesday at the close of the comment period submitted a letter to FDA calling for the approval of Barr's application. According to a coalition release, the letter says that studies show women of all ages can safely and effectively use nonprescription Plan B and that requiring a prescription "creates a medically unjustified barrier to getting this back-up birth control method in time for it to work" (Coalition release, 11/1).

Philadelphia Inquirer Examines Media Coverage, Advocacy Effect on EC The Philadelphia Inquirer on Tuesday examined how media coverage of FDA's delayed decision has helped advocates' efforts to promote EC. The number of annual prescriptions for Plan B have doubled to 1.6 million during the two years since Barr first applied for nonprescription Plan B sales. The application "has generated a ton of publicity, and that almost surely has a consequence of increasing awareness, and awareness is still the biggest barrier to use," James Trussell, a Princeton University economist and proponent of EC, said. Some conservatives say that making Plan B available without a prescription would enable rapists to "cover up their abuse," expose women to medical problems and encourage increased "risky" sexual behavior, the Inquirer reports.

DOJ Sexual Assault Guidelines There also has been "fallout" from the Department of Justice's exclusion of EC from its first national guidelines for treating sexual assault survivors, the Inquirer reports (McCullough, Philadelphia Inquirer, 11/1). The guidelines, released in September 2004, include a section on pregnancy risk evaluation and care but do not specifically mention EC (Kaiser Daily Women's Health Policy Report, 7/16). The American Civil Liberties Union of Pennsylvania on Monday launched a Web site, RaisingHerVoice.org, where sexual assault survivors can share experiences of being offered or denied EC at hospitals and pharmacies (Philadelphia Inquirer, 11/1). The site -- hosted by the Clara Bell Duvall Reproductive Freedom Project -- also contains basic information about EC and how to access it, links to sexual assault resources and allows questions to be submitted to a physician (ACLU-PA release, 11/1). Wendy Wright, executive vice president of Concerned Women for America, defended DOJ's guidelines, saying Catholic hospitals and physicians with moral objections to EC use should not feel obligated to dispense it (Philadelphia Inquirer, 11/1).