Jay Inslee: Washington's 1st Congressional District

Issues

Families

Support for Emergency Contraception in Advance of FDA Announcement

21 January 2005

Today the Food and Drug Administration (FDA) was expected to announce whether it would allow making the emergency contraception Plan B available over-the-counter for women ages 16 and older. In anticipation of the announcement, U.S. Rep. Jay Inslee and 54 Members of Congress sent a bipartisan letter to the FDA in support of making the emergency contraception Plan B available over-the-counter for women ages 16 and older. Unfortunately, the FDA instead announced that it would further delay its decision.

Said Inslee:

The FDA should have enough information to make a decision on Plan B and I fear that politics might have taken precedent over women's health in pushing back the FDA's decision. While the delay is disappointing, I am hopeful that the FDA will recognize the benefit to public health by making Plan B available over-the-counter to women.

Women seeking emergency contraception should not have to jump through hoops to prevent unintended pregnancies. Washington State has led the nation in showing that emergency contraception is safe, effective and well accepted in our communities. Increasing accessibility to emergency contraception will reduce the number of unintentional pregnancies and abortions in America. We hope the rest of the country can follow our state's leadership by making Plan B more readily available.

Experts estimate that the widespread use of emergency contraceptives (EC) could prevent as many as half of the nearly three million unintended pregnancies that occur in the United States each year, including as many as 700,000 unintended pregnancies that now result in abortion.

Background

Currently, Plan B has been approved by the FDA, but women may only access it with a prescription unless their state allows pharmacies to dispense it over-the-counter. Washington State is one of only five states that already allow pharmacies to directly distribute emergency contraception. Therefore, the FDA ruling would not change access to Plan B at participating pharmacies in Washington State, but would give non-participating pharmacies across the state and country the ability to dispense Plan B over-the-counter. Not all Washington State pharmacies currently participate in this program. Washington State law specifies that all family planning decisions be left up to the patient, regardless of age.

Plan B does not cause an abortion. Rather, Plan B is a concentrated form of the hormone progestin, which is found in daily birth control pills. If taken within seventy-two hours, emergency contraception can reduce pregnancy by eighty-nine percent. Plan B prevents ovulation and can prevent an egg from implanting into the uterus. Plan B does not stop a pregnancy that has already occurred. Last year, despite the overwhelming support of an independent expert advisory panel's 23-to-4 recommendation that Plan B be made accessible without a prescription, the FDA rejected Barr Laboratories' request to give the drug over-the-counter status.

The text of the letter from the Members of Congress to the FDA is as follows:

January 19, 2005

The Honorable Lester M. Crawford

Commissioner

U.S. Food and Drug Administration

5600 Fishers Lane

Rockville, Maryland 20857

Dear Dr. Crawford:

We would like to voice our support for Barr Laboratories' application to make the emergency contraceptive pill Plan B available over-the-counter (OTC) to women ages 16 and older. We recognize access to emergency contraception (EC) as having a critical role in the goal to prevent unintended pregnancies and reduce the need for abortion in the United States.

While we support unrestricted access to EC for all women, we believe that making Plan B available OTC to women 16 and older is a significant step in the right direction. Already, several states recognize the importance of timely access to Plan B by allowing pharmacists to directly dispense the contraceptive to women.

In December 2003, two independent expert FDA advisory panels overwhelmingly recommended making the emergency contraceptive, Plan B, available over-the-counter by a vote of 23 to 4. The switch to OTC status is scientifically and medically justified and meets the criteria for an OTC drug product: it is safe, effective, and easily self-administered.

As you know, approved for use by the FDA, EC is a concentrated form of the same hormones in daily birth control pills that prevents unintended pregnancy when taken after unprotected sex or contraceptive failure. If taken within 72 hours, EC can reduce the risk of pregnancy by 89 percent. Whether "pro-life" or "pro-choice" we all recognize the need to reduce unintended pregnancy. Experts estimate that widespread use of emergency contraception could prevent as many as half of the nearly 3 million unintended pregnancies that occur in the U.S. each year, including as many as 700,000 pregnancies that now result in abortion. (Trussell J, et al. Emergency contraceptive pills: a simple proposal to reduce unintended pregnancies. Family Planning Perspectives 1992; 24: 269-273.) (Note: Trussell et al based their calculations on higher rates of unintended pregnancy and abortion than current rates. The specific numbers of unintended pregnancies and abortions that could be averted by widespread knowledge and use of emergency contraception are based on more recent data, found in Henshaw SK. Unintended pregnancy in the United States, Family Planning Perspectives, 1998, 30(1):24-29 & 46).

Furthermore, in order to be effective, a woman must take emergency contraception within days of unprotected sex - and the sooner, the better. Because of this narrow window of effectiveness, timely over the counter access to emergency contraception is a critical aspect in preventing pregnancy and reducing the need for abortion. (Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. The Lancet. 1998; 352: 428-433. See also Ellertson C et al. Extending the time limit for starting the Yuzpe regimen of emergency contraception to 120 hours. Obstet Gynecol 2003; 101: 1168-1171. See also Von Hertzen, H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. The Lancet 2002; 360: 1803-1810. See also Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraceptive pills between 72 and 120 hours after unprotected intercourse. Am J Obstet Gynecol 2001;184(4): 531-537.)

It is also important that we draw your attention to a study published in the Journal of the American Medical Association published January 5, 2005, which indicates that ready access to emergency contraception increases its use, but does not make women more likely to engage in sexual risk taking behaviors or acquire sexually transmitted diseases. These findings undermine claims that making emergency contraception more available to teens and adult women will increase risk-taking behaviors such as unprotected sex. (Raine T. et al, Increased Access to Emergency Contraception and Impact on Pregnancy and STIs: A Randomized Controlled Trial, Journal of the American Medical Association, 2005;293:54-62.)

As you review the data on Plan B, we urge you to consider that a woman's access to EC plays a critical role in preventing unintended pregnancy and reducing the need for abortion. We support the approval of Barr Laboratories' application. Thank you for your consideration of this request.

Sincerely,

JAY INSLEE (D-WA)

DIANA DEGETTE (D-CO)

LOUSIE SLAUGHTER (D-NY)

CHRISTOPHER SHAYS (R-CT)

Rob SIMMONS (R-CT)

TAMMY BALDWIN

JOHN CONYERS, JR.

CHRIS VAN HOLLEN

ANNA G. ESHOO

JAMES P. MORAN

SHEILA JACKSON-LEE

JANE HARMAN

PETER A. DEFAZIO

ADAM SMITH

CAROLYN B. MALONEY

JIM MCDERMOTT

CAROLYN MCCARTHY

HILDA L. SOLIS

PATRICK J. KENNEDY

DENNIS J. KUCINICH

SHERROD BROWN

ANTHONY D. WEINER

JUANITA MILLENDER-MCDONALD

STEVE ISRAEL

TIMOTHY H. BISHOP

RAUL M. GRIJALVA

LLOYD DOGGETT

HOWARD L. BERMAN

JOHN W. OLVER

SAM FARR

ROSA L. DELAURO

HENRY A. WAXMAN

STEVEN R. ROTHMAN

DANNY K. DAVIS

NANCY L. JOHNSON

JOHN F. TIERNEY

BRIAN BAIRD

RUSS CARNAHAN

RUSH D. HOLT

JAMES P. MCGOVERN

WILLIAM LACY CLAY

SUSAN A. DAVIS

JOSEPH CROWLEY

LOIS CAPPS

PETE FORTNEY STARK

NEIL ABERCROMBIE

GARY L. ACKERMAN

JANICE D. SCHAKOWSKY

NYDIA M. VELÁZQUEZ

JULIA CARSON

SHELLEY BERKLEY

GEORGE MILLER

NITA M. LOWEY

TOM ALLEN