Antiabortion Groups Oppose FDA Nomination
Groups that oppose abortion rights are calling on President Bush to withdraw the nomination of acting FDA Commissioner Andrew von Eschenbach to permanently head the agency because FDA might approve Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B for women ages 18 and older, the AP/Houston Chronicle reports (Bridges, AP/Houston Chronicle, 8/17).
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
(California Healthline, 8/2).
"FDA is contacting both the antiabortion groups and their main opponent, Planned Parenthood, to hear their last-minute arguments over the fate" of the Plan B application, the AP/Chronicle reports.
FDA spokesperson Susan Bro said the agency "always reach[es] out to third-party groups with virtually every decision, ... especially with decisions that have been difficult and complex and not always a clear consensus."
Wendy Wright -- president of Concerned Women for America, which has led the opposition to nonprescription sales of Plan B -- said FDA ignored her input during the public comment period on the drug.
Paul Chaim Schenck, director of the National Pro-Life Action Center, said, "If the president pushes for this nominee, he is only going to undercut the support and his own party needs in the elections."
According to the AP/Chronicle, von Eschenbach "already is facing a roadblock from the other side" because "Democrats are upset that FDA has long delayed settling the three-year debate over whether at least some women could buy" Plan B without a prescription (AP/Houston Chronicle, 8/17).
After President Bush nominated von Eschenbach, Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) announced in a statement that they planned to place a hold on his confirmation vote in the Senate until FDA made a decision on the application (American Health Line, 7/26).
White House spokesperson Tony Snow said the president "continues to strongly support Dr. von Eschenbach's nomination" (AP/Houston Chronicle, 8/17).