For Immediate Release:

Friday, March 18, 2005

(WASHINGTON, D.C.) – U.S. Senator Patty Murray, a member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today pressed acting FDA Commissioner Lester Crawford to answer questions about a long-pending application for nationwide over-the-counter approval of Plan B emergency contraceptives.

Plan B, also known as the “morning after pill,” prevents unintended pregnancies. It was approved for prescription use in 1999. While four states, including Washington, have agreements allowing non-prescription access, Plan B has not yet been approved for nationwide over-the-counter use. The original application for nationwide access was filed with FDA in the fall of 2003. Although FDA’s expert advisory committee voted overwhelmingly in favor of approval, FDA has not yet approved the application.

Unsatisfied with Crawford’s lack of answers, Murray asserted the need for a specific briefing on the hold-up of Plan B’s over-the-counter application prior to the Committee’s confirmation of him as FDA Commissioner. Murray’s questioning resulted in an agreement from Crawford and members of the HELP Committee to a briefing on the status of the Plan B application prior to that vote.

“I am glad we’ve been able to get a commitment from acting commissioner Crawford to meet and discuss the application for Plan B emergency contraceptives,” Murray said. “This is too important a decision to be endlessly delayed for political reasons. It is a decision that should be based on sound science and public health needs, not on politics.”

In March of last year, Senator Murray sent a letter to then-commissioner Mark McClellan requesting the expeditious approval of the over-the-counter application. Though incoming acting commissioner Crawford was also sent a copy of the letter at the time, no action has since been taken on the application.