Kaiser Daily Women's Health Policy Report Summarizes Editorials On Approval Of Nonprescription Plan B Sales To Women Over Age 18

Some editorials and opinion pieces respond to FDA's decision on Thursday to approve Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B to women ages 18 and older. The approval came after the agency in May 2004 issued a "not approvable" letter in response to an application originally submitted by the 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 Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. 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. Barr earlier this month resubmitted its application. The approval requires Barr to "[m]onitor the effectiveness of the age restriction and the safe distribution of [nonprescription] Plan B to consumers [ages] 18 and above and prescription Plan B to women under [age] 18." Barr has agreed to send "anonymous shoppers" into pharmacies to test compliance with the age restriction, to distribute with the drug a booklet about its proper use and to exclude gas stations and convenience stores from selling the drug. Barr spokesperson Carol Cox said Plan B should be available for nonprescription sales this fall (Kaiser Daily Women's Health Policy Report, 8/25).

Editorials
Philadelphia Inquirer: FDA's decision to limit nonprescription sales of Plan B to women older than 18 is "about moral preference, not science; about preserving parents' control over minor children, not medical prudence," an Inquirer editorial says. Although the decision "won't please family planning groups that argued against" age restrictions or "those who consider Plan B a form of abortion," it is the "best decision the nation could expect of this administration," the editorial says (Philadelphia Inquirer, 8/25).

Seattle Post-Intelligencer: By approving nonprescription sales of Plan B to women ages 18 and older, FDA has "finally taken a big step to prevent pregnancies, protect health and reduce" the number of abortions, a Post-Intelligencer editorial says. However, the "decision included a compromise based on ideology" because it does not allow for nonprescription sales among girls ages 17 and younger, according to the editorial. "At the state and national levels, ideology has inserted itself into the discussions," the editorial says, concluding, "Science, the facts and the need to reduce the high U.S. teen birth rate ought to guide the decisions" (Seattle Post-Intelligencer, 8/25).

Opinion Pieces
Maureen Downey, Atlanta Journal-Constitution: The FDA approval "signals a rare victory for women's reproductive health, which has been a casualty of the Republican Party's courtship of far right extremists," Downey, a member of the Journal-Constitution's editorial board, writes in an opinion piece. However, the "18-and-older rule is a political mollification" that has "no scientific or health basis," Downey writes, adding that it also is "unfortunate because it's teenagers who engage in unprotected sex and have less access to birth control than their peers worldwide" (Downey, Atlanta Journal-Constitution, 8/25).

David Stevens, Atlanta Journal-Constitution: FDA's decision concerning Plan B was "influenced by political pressure," Stevens, executive director of the Christian Medical and Dental Associations, writes in a Journal-Constitution opinion piece. By "allowing both prescription" and nonprescription sales of Plan B, FDA "appears" to be creating an "entirely new type of approval that neither has been authorized by Congress nor subjected to a formal rulemaking process," Stevens writes, adding that it is questionable how FDA will be able to ensure that "this scheme is followed" (Stevens, Atlanta Journal-Constitution, 8/25).

Mary Worthington, Philadelphia Inquirer: While "we can make no simplistic post hoc correlations here between access to a drug and wholesale sexual behavior," two European studies have shown after Plan B became available without a prescription, sexually transmitted infection rates increased and abortion rates either increased or did not decrease, Worthington of Generation Life writes in an Inquirer opinion piece. FDA has "made a mistake in according" nonprescription "status to Plan B," Worthington writes, concluding, "Here's hoping the policy is revised or ended soon" (Worthington, Philadelphia Inquirer, 8/25).















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