Barr Laboratories will amend the age restriction in its application for nonprescription sales of its emergency contraceptive Plan B, but it cannot be accountable for pharmacies that do not abide by the restrictions, company CEO Bruce Downey said Wednesday, Reuters reports (Heavey, Reuters, 8/9). 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 that science supported approval of nonprescription Plan B access for women and girls ages 17 and older but that 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, acting FDA Commissioner Andrew 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." The company and FDA officials on Tuesday met in Washington, D.C., to discuss the application (Kaiser Daily Women's Health Policy Report, 8/9). Downey on Wednesday said the company had not yet made a decision on whether to amend its application to reflect FDA's proposal to raise the age restriction for nonprescription sales to 18. "Access [to Plan B] is the main consideration" in deciding whether to raise the age restriction, Downey said, adding that a higher age restriction might make it more difficult for teens to obtain Plan B quickly (Bloomberg/Boston Globe, 8/10). He said, "If you're 17 and need [Plan B], you need it just as quickly as someone who is 31 and needs it." Downey on Wednesday also responded to the letter's questions on how the company would hold pharmacists who do not follow the restrictions accountable, saying, "Ultimately, we can't prohibit a pharmacist from not living up to his ... or her obligations" of following the restrictions related to Plan B sales. He added, "I am confident most pharmacists are responsible people, and they will abide by the law." Downey also said that if Plan B were approved for nonprescription sales, it would be available in a few months to allow the company time to change the packaging for the nonprescription version (Reuters, 8/9).

Sen. Murray 'Cautiously Optimistic' About Plan B Decision
In related news, Sen. Patty Murray (D-Wash.) said she is "cautiously optimistic" that Tuesday's meeting between FDA and Barr will lead to a decision on the application for nonprescription sales of Plan B, Murray spokesperson Alex Glass said Wednesday, CQ HealthBeat reports. Glass added, "We still have questions and concerns, but we think the meeting is a step forward." Glass said that one concern is determining whether FDA is "following the science" in its decision to restrict sales of Plan B to women ages 18 and older or if its actions are based on political pressure from social conservatives (Reichard, CQ HealthBeat, 8/9). Murray and Sen. Hillary Rodham Clinton (D-N.Y.) have said they will continue to block von Eschenbach's confirmation to permanently head FDA until the agency announces whether it will approve or reject nonprescription sales of Plan B (Kaiser Daily Women's Health Policy Report, 8/9). According to Glass, the hold is contingent on FDA making a final decision but not on the outcome of the decision. "We've asked for a 'yes' or 'no' decision," she said (Reichard, CQ HealthBeat, 8/9).

Related Editorials

• Lincoln Journal Star: "The shameful political games over" Plan B have continued for three years, and despite some predictions that the debate soon might end, "it would be folly ... to assume we've reached the endgame," a Star editorial says. Even though Plan B "should be available without a prescription," there still are "many possibilities that approval could stall," the editorial says, explaining, "FDA could find fault with Barr's plans, and we'd be back at square one"; von Eschenbach's confirmation might be put on hold by Senate Democrats; or "President Bush could push von Eschenbach through via another one of his recess appointments" (Lincoln Journal Star, 8/7).
  


• Philadelphia Inquirer: FDA should approve nonprescription sales of Plan B and "get back to business" because the "divisive ... debate has paralyzed the agency long enough," an Inquirer editorial says. "[P]olitical interference ... needs to stop," and the agency "must act independently to maintain its standard of excellence and retain public confidence," according to the editorial. "Research supports FDA approval of emergency contraception," the editorial says, concluding, "The Senate should confirm von Eschenbach, so FDA can get back to science and safety and out of politics" (Philadelphia Inquirer, 8/8).