Brief Description: Asking for over-the-counter access status to "Plan B."

Sponsors: Senators Keiser, Franklin, Kohl-Welles, Thibaudeau, Kline and McAuliffe.

Brief History:

Committee Activity: Health & Long-Term Care: 2/1/06, 2/2/06 [DPS, DNP, w/oRec].

SENATE COMMITTEE ON HEALTH & LONG-TERM CARE

Majority Report: That Substitute Senate Joint Memorial No. 8032 be substituted therefor, and the substitute joint memorial do pass.Signed by Senators Keiser, Chair; Thibaudeau, Vice Chair; Franklin, Kastama, Kline and Poulsen.

Minority Report: Do not pass.Signed by Senators Benson and Johnson.

Minority Report: That it be referred without recommendation.Signed by Senators Brandland and Parlette.

Staff: Edith Rice (786-7444)

Background: Plan B is emergency contraception. It is in the form of two Levonorgestrel pills that are taken by mouth after unprotected sex. Levonorgestrel is a synthetic hormone used in birth control pills for over 35 years. Plan B prevents pregnancy primarily by stopping the release of an egg from the ovary. It may prevent fertilization, and if fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb. If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.

The Food and Drug Administration received an application to switch Plan B from prescription to nonprescription (over-the-counter) status. In December 2003, the members of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health met jointly to consider the safety and effectiveness data of nonprescription use of Plan B. The joint committee recommended to the FDA that this product be sold without a prescription. However, some members of the committee, including the chair, raised questions concerning the data presented.

After completing its review the FDA denied approval of nonprescription status for Plan B because (1) adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and (2) a request from the sponsor to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for full review.

Summary of Substitute Bill: The Senate and the House of Representatives of the state of Washington request that the President, Congress, and the Food and Drug Administration take necessary action to grant over- the-counter access status to Plan B.

Substitute Bill Compared to Original Bill: Language is substituted to clarify that Washington State has allowed specially trained pharmacists to prescribe and dispense emergency contraception since 1997, and this may have contributed to a decline in abortion rates.

Appropriation: None.

Fiscal Note: Not requested.

Committee/Commission/Task Force Created: No.

Testimony For: There is a lot of misinformation about Plan B. The public needs to be informed that it prevents ovulation and fertilization to begin with and does not harm an existing pregnancy. FDA scientific experts agree that Plan B is safe in a non-prescriptive setting.

Testimony Against: Plan B amounts to an overdose of birth control pills, and creates a heightened risk of ectopic pregnancy. Users should seek the advice of a physician.

Who Testified: PRO: Don Downing, University of Washington; Amy Luftig, Planned Parenthood.

CON: Matt Muckler, Washington State Catholic Conference.