“The FDA advisory committee has recommended approval of Plan B based on safety and effectiveness, but the FDA continues to drag its feet,” Senator Murray said. “I have always supported a strong and independent FDA, but by ignoring sound science, they have jeopardized public confidence and the health of American women. This is too important a decision to be endlessly delayed for ideological reasons.”
“We appreciate Dr. Crawford coming in to meet with us today, but the bottom line is that the FDA has had the Plan B application for years and the American people simply need an answer yes or no. Science should never take a back seat to politics and ideology,” Senator Clinton said.
At a Health Education Labor and Pensions (HELP) Committee hearing last month, Murray pressed Crawford to answer questions about a long-pending application for nationwide over-the-counter approval of Plan B emergency contraceptives. Unsatisfied with Crawford’s lack of answers, Murray asserted the need for a specific briefing on the status of Plan B prior to a vote on Crawford’s nomination.
Crawford today briefed Senators Murray, Clinton, and Ted Kennedy (D-MA) in Murray’s Washington, D.C. office but failed to provide answers as to when a decision on Plan B could be expected, despite having already missed the Prescription Drug User Fee Act deadline in January 2005.
Murray and Clinton intend to place a hold on Crawford’s nomination following his HELP Committee confirmation hearing on April 13, preventing a vote before the full Senate. They will continue the hold until FDA makes a decision on Plan B’s over-the-counter status.
“The approval of Plan B should be made based on the public health needs of women across the country, not concerns over ‘behavior’ or philosophical beliefs,” Murray said. “American consumers demand an independent FDA, and American women deserve direct access to safe and effective treatments. Senator Clinton and I will hold FDA to that standard.”
Timeline of FDA’s Approval Process for Plan B:
- July 1999 - The FDA approved "on label" use of Plan B as an emergency contraceptive available by prescription.
- April 2003 - The manufacturer submitted an application to the FDA requesting that Plan B be approved for over-the-counter (OTC) use.
- 8 months pass
- December 2003 - The FDA Advisory Committee overwhelmingly recommends the OTC approval (24-3)
- February 2004 - The FDA postpones its decision on the Plan B for 90 days.
- 3 months pass
- May 2004 - FDA rejects the application, stating concerns about the safe use of the drug by women under age 16.
- July 2004 - The manufacturer submits a response to FDA asking for OTC with age restrictions.
- 6 months pass
- January 2005 - The FDA delays its decision on Plan B again, indicating to the manufacturer that it will complete its review of the application in the near future.
- 2 months pass
- March 17, 2005 - At a HELP Committee hearing on the confirmation of FDA Nominee Lester Crawford, Senator Murray pressed Crawford to explain the delays in approving Plan B for over-the-counter use. Crawford agreed to brief Murray and other HELP Committee before his confirmation hearing.
- April 6, 2005 - Nominee Crawford meets with Senator Murray and other HELP Committee members in Murray's Washington, D.C. office.