Barr Laboratories, Inc.

‘PLAN B’ AND THE POLITICS OF THE FDA:Influencing the decision to allow emergency contraception to be sold over-the-counter for women

What is Plan B? A form of emergency contraception

-Blocks the hormone progesterone, which helps maintain pregnancies

-Contains a higher dose of regular hormonal birth control pills

that prevent pregnancy

Currently available to ALL women as a prescription drug

When taken within 72 hours of unprotected intercourse, can reduce the risk of pregnancy by 89%

Available over-the-counter (OTC) in seven states

102 countries have it available OTC, 34 of which do not require prescription

NOT the same as RU-486

Plan B and the FDA

1999: FDA approves Plan B as a prescription medication

April 2003: Barr submits application to FDA requesting that Plan B be made available without a prescription for women

Dec. 2003: FDA’s drug advisory committee votes 23-4 to recommend OTC sale

May 2004: FDA rejects Barr’s initial application

o July 2004: Barr submits second application proposing market of Plan B as prescription-only to girls under 16 and OTC status to older users

July 18, 2005: Lester Crawford confirmed as FDA Commissioner

Aug. 26, 2005: Crawford asks for 60-day comment period from public

Aug. 31, 2005: Susan Wood, director of FDA’s Office of Women’s Health quits

Sept. 28, 2005: Lester Crawford, FDA Commissioner resigns

STRATEGY

Coalition Building

Diversify Political Support

Advocate Policy Alternatives

Trump Opposition

COALITION BUILDING Advocacy Groups ▪ American Civil Liberties Union (ACLU) ▪ Feminist Majority Foundation ▪ Society for Women’s Health Research ▪ Morning-After Pill Conspiracy (MAP) Associations ▪ American College of Obstetricians and Gynecologists ▪ American Medical Association ▪ American Medical Women’s Association ▪ American Society for Emergency Contraception ▪ Association of Reproductive Health Professionals (ARHP) ▪ National Family Planning and Reproductive Health Association ▪ Pharmaceutical Manufactures Association NGO’s ▪ National Organization for Women (NOW) ▪ NARAL ▪ National Women’s Health Network ▪ National Women’s Law Center ▪ Planned Parenthood Federation of America ▪ Pro-Choice America Research ▪ The Reproductive Health Technologies Project (RHTP) ▪ Family Health Research ▪ Women’s Information Network

DIVERSIFY POLITICAL SUPPORT

Senator Patty Murray (D- Washington) Senator Barbara Mikulski (D- Maryland) Senator Hillary Clinton (D- New York) Senator Carolyn Maloney (D- New York) Senator Edward Kennedy (D- Massachusetts) Senate Committee on Health, Education, Labor, and Pension (HELP)

-Chairman: Michael Enzi (R- Wyoming)

Senators Ted Stevens & Lisa Murkowski (R- Alaska) Senators Barbara Boxer & Dianne Feinstein (D- California) Senators Daniel Akaka & Daniel Inouve (D- Hawaii) Senators Susan Collins & Olympia Snowe (R- Maine) Senators Jeff Bingaman & Pete Domenici (D,R- New Mexico) Senators Judd Gregg & John Sununu (R- New Hampshire) Senators Maria Cantwell & Patty Murray (D- Washington)

If members are willing to support Barr, the firm can allocate funds towards each Senator’s campaignre-election.

POLICY ALTERNATIVES

Promote a non-political appointment for head of the FDA

Before receiving Senate confirmation, the nominee for FDA commissioner must explain his/her values affecting their decision regarding approval of Plan B

Pressure the Bush Administration to submit a nominee before the end of the year that supports the belief that the FDA remains a science-based organization

Compel the Government Accountability Office to investigate the FDA’s handling of Plan B

TRUMP OPPOSITION Leading opposition groups to Plan B’s approval include:

American Life League Concerned Women for America Catholic Medical Association American Association of Pro-Life Obstetricians and Gynecologists

Opponents argue against over-the-counter approval of the emergency contraceptive because:1) Want to restrict access to the drug2) Believe it encourages promiscuity 3) Causes abortions4) Think it is not safe

o Implement a mass media campaign to debunk myths regarding Plan B

o Target Senators from states where Plan B is given OTCo Build on the volume of Opinion/Editorials that have been written in

support of Plan Bo Advertising, media releases, coalition building

C O N C L U S I O N

Plan B is a consumer pharmaceutical product that needs to be marketed as an OTC drug

Barr should implement a nonmarket strategy that entails:Coalition BuildingPolitical SupportPolicy AlternativesA Refute Against Opposing Arguments