Barr Laboratories, Inc.

1
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

2
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

3
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 FDAs drug advisory
  committee votes 23-4 to recommend OTC sale
• May 2004 FDA rejects Barrs initial
  application
• 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 FDAs
  Office of Womens Health quits
• Sept. 28, 2005 Lester Crawford, FDA
  Commissioner resigns

4
STRATEGY

• Coalition Building
• Diversify Political Support
• Advocate Policy Alternatives
• Trump Opposition

5
COALITION BUILDING

• Advocacy Groups
• ? American Civil Liberties Union (ACLU)
• ? Feminist Majority Foundation
• ? Society for Womens Health Research
• ? Morning-After Pill Conspiracy (MAP)
• Associations
• ? American College of Obstetricians and
  Gynecologists
• ? American Medical Association
• ? American Medical Womens Association
• ? American Society for Emergency Contraception
• ? Association of Reproductive Health
  Professionals (ARHP)
• ? National Family Planning and Reproductive
  Health Association
• ? Pharmaceutical Manufactures Association
• NGOs
• ? National Organization for Women (NOW)
• ? NARAL
• ? National Womens Health Network
• ? National Womens Law Center
• ? Planned Parenthood Federation of America

6
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 Senators
  campaign
• re-election.

7
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 FDAs handling of Plan B

8
TRUMP OPPOSITION

• Leading opposition groups to Plan Bs 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 drug
• 2) Believe it encourages promiscuity
• 3) Causes abortions
• 4) Think it is not safe
• Implement a mass media campaign to debunk myths
  regarding Plan B
• Target Senators from states where Plan B is given
  OTC
• Build on the volume of Opinion/Editorials that
  have been written in support of Plan B
• Advertising, media releases, coalition building

9
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 Building
• Political Support
• Policy Alternatives
• A Refute Against Opposing Arguments