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