Murray, Clinton Place “Hold” on Nomination of FDA Head

Jun 15 2005

Senators unsatisfied with lack of answers, continued delays on approval of Plan B for over-the-counter use

(WASHINGTON, D.C.) – U.S. Senators Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-NY), members of the Senate Health Education and Labor Committee (HELP), today voted against the nomination of Dr. Lester Crawford to head the Food and Drug Administration (FDA) and placed a hold on his nomination, delaying consideration by the full Senate.

The Senators’ hold will remain in effect until FDA issues a yes or no decision on the over-the-counter application of Plan B emergency contraceptives.

“We are asking FDA to explain why they are delaying an over-the-counter application for Plan B that even their own Advisory Panel overwhelmingly recommended for approval. We are not asking for a specific outcome, but for some final outcome,” Senator Murray said. “American consumers demand an independent FDA and American women deserve direct access to safe and effective treatments. I fear that the case of Plan B highlights a leadership problem at FDA – a leadership that can be biased or open to undue influence.”

“Our request is simple and straightforward. We want the FDA to make a decision – yes or no. After almost two years of waiting, the American people have the right to an answer,” said Senator Clinton. “At a time when the FDA needs a strong leader to restore its reputation, I fear that Dr. Crawford’s record demonstrates a lack of vision and drive to ensure that the FDA upholds its gold standard of drug regulation. He has failed to address the concerns raised by his own employees about the needs of the agency. And he cannot provide assurances that the FDA will make science, not ideology or other interests, the cornerstone of its decision making.”

At a HELP Committee hearing in March, the Senators pressed Crawford to answer questions about a long-pending application for nationwide over-the-counter approval of Plan B contraceptives. The FDA Advisory Committee overwhelmingly recommended over-the-counter approval in December of 2003, but a decision has still not been made.

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 briefed Senators Murray, Clinton and Ted Kennedy (D-MA) on April 6th, but failed to provide an answer 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.

Two months have passed since the Senators met with Crawford and FDA has still not moved forward with a decision on Plan B.

“All we are asking for today is that FDA follows procedures set out in law for drug approval. American patients deserve access to safe and effective treatments in a timely manner,” Murray said. “We are placing a hold on Dr. Crawford because it is time to return credibility to FDA.”

“The law that governs the timing of FDA decisions – the Prescription Drug User Fee Act (PDFA) – demands that the FDA make decisions on applications within ten months of the original application’s submission and within six months of an amended application. In the case of Plan B, the deadline was January 21, 2005. It has been almost five months since that date. PDFUA has clearly been violated,” Clinton said. “I am calling upon the GAO today to expedite their review so that the Senate is able to have the best information at its disposal.”

A timeline of FDA’s approval process for Plan B follows.


TIMELINE: FDA Approval Process for Plan B Emergency Contraceptive

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, Senators Murray and Clinton pressed Crawford to explain the delays in approving Plan B for over-the-counter use. Crawford agreed to brief HELP Committee members before his confirmation hearing.

April 6, 2005 - Nominee Crawford meets with Senators Murray, Clinton and Kennedy in Murray's Washington, D.C. office.

1 month passes...

May 12, 2005 - Senators Murray and Clinton urge Secretary of Health and Human Services Michael Leavitt to launch an investigation into a memo sent by Dr. David Hager to Acting Commissioner Lester Crawford on Plan B.

1 month passes...

June 15, 2005 - HELP Committee votes on nomination of Crawford.