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Plan B OTC Application
- Executive Director Belle Taylor-McGhee Says Plan B OTC Access is Long-Overdue Victory (PDF-96K) (August 24, 2006)
- FDA Approves Plan B for Non-Prescription Sale for Women 18 and Older (August 24, 2006)
- After Meeting with FDA, Barr Labs to Resubmit Plan B OTC Application (August 9, 2006)
- Pharmacy Access Partnership Executive Director Belle Taylor-McGhee Says Von Eschenbach Failed to Boost Confidence in FDA During Senate Hearing (August 1, 2006)
- FDA Announces Framework to Bring Plan B OTC Within Weeks (July 31, 2006)
- FDA Sends Letter to Duramed Requesting Meeting to Discuss Bringing Plan B OTC (July 31, 2006)
- Amidst Murray/Clinton Hold, Senate Committee on Health, Education, Labor and Pensions to Hold von Eschenbach Confirmation Hearing on Aug 1 (PDF-12K) (July 25, 2006)
- Legal depositions reveal that Crawford acted did not consult FDA leadership in Plan B delay (May 24, 2006)
- McClellan Discussed Plan B With White House Official, CRR Attorney Says (May 15, 2006)
- Bush Nominates Von Eschenbach to Head FDA; Clinton, Murray Place Hold on Confirmation Vote (March 16, 2006)
- Pharmacy Access Partnership and Dr. Susan Wood meet with San Francisco Chronicle editorial board on FDA, Plan B. Read editorial. (December 12, 2005)
- Dr. Susan Wood Addresses Pharmacy Access Partnership Gala Event. Read more. (November 29, 2005)
- Pharmacy Access Partnership demands accountability, action from FDA (PDF-40K) (November 15, 2005)
- Former Director of the FDA Office on Women’s Health Dr. Susan Wood releases statement on GAO report (PDF-12K) (November 14, 2005)
- GAO Releases Report Calling FDA Decision Delay “Unusual” (PDF-1MB) (November 2005)
- House of Representatives Sends Letter Urging HHS Sec. Leavitt to “Renounce the Manipulation of Science” (PDF-356K) (November 14, 2005)
- Barr Proposes Dual Marketing Status (DOC-28K) (July 22, 2004)
- FDA Issues Not Approvable Letter to Barr (May 7, 2004)
- FDA’s Decision: Questions and Answers (May 7, 2004)
- Plan B OTC Application Timeline (PDF-24K) (April 2003-April 2006)
- Options
For Getting Involved in EC OTC Initiative
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On August 24, 2006, the FDA decided to make Plan B EC available without a prescription for consumers 18 and older. Following this decision, all women, including teens and women without proof of age, will still be able to obtain EC directly from specially trained pharmacists (in the states that allow pharmacy access to EC). Click here for more information on the FDA decision.
On August 1, 2006, Acting FDA Commissioner Andrew von Eschenbach, who was nominated by President Bush in March 2006 to permanently head the agency, discussed the Plan B application during his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions. Shortly after the nomination was announced in March, Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) announced that they would place a hold on his confirmation vote in the Senate because of the delay on the Plan B decision. Following the Plan B decision, Clinton and Murray lifted the hold. Dr. von Eschenbach’s confirmation is still pending in the Senate.
In the case brought against FDA in 2001 and argued by the Center for Reproductive Rights, CRR attorneys in April 2006 deposed FDA Deputy Commissioner Dr. Janet Woodcock and the Director of the FDA’s Center for Drug Evaluation and Research, Dr. Steven Galson, who stated that Crawford did not consult them in his decision to delay the Plan B decision. Galson testified that Crawford "told me that he was concerned about where we were heading because he knew that I was heading towards” recommending over-the-counter status for Plan B for use among girls 17 and up, “and he told me that he was going to make the decision on what to do with the application.” Attorneys in the CRR case also reported that Center for Medicaid and Medicare Services Administrator Mark McClellan, while head of FDA, discussed the Plan B application with a White House official while the Barr application for nonprescription status was pending.
A bipartisan group introduced a bill (HR 4229) on November 4, 2005, that, if passed, would make Plan B (the dedicated product for EC) available nationwide without a prescription, for women 17 years and older. The move comes in response to the FDA’s delay in making a decision whether to grant Plan B over-the-counter (OTC) status. The measure would require the FDA to make a decision within 30 days of the bill’s passage, after which time Plan B would automatically be approved for OTC sales. If Plan B is granted OTC status through this legislation, the FDA would still have the power to override the approval at a later date. For comments from Rep. Joseph Crowley, click here.
This move comes only days after the deadline for submission for public comment on the issue to the FDA. November 1, 2005, ended the 60-day period to submit comments regarding the pending application to make EC available OTC. The request for public comment came on the heels of the FDA’s most recent delay to grant EC non-prescription status, despite Barr Pharmaceuticals’ efforts to allay the agency’s concerns about teen use, in addition to a wealth of scientific evidence showing that the regimen is safe and effective for women of all ages. According to a senior FDA official who spoke to the Washington Post, as of the November 1 deadline the agency had already recorded receipt of 2,300 comments and was expecting upwards of 10,000 after the final tallies were in. See comments supporting OTC status for EC submitted by Pharmacy Access Partnership (PDF-508), the Reproductive Health Technologies Project and Senators Hillary Clinton (D-NY) and Patty Murray (D-WA), which included 10,000 signatures from advocates nationwide.
The FDA was expected to issue a decision on an application to switch Plan B, the product currently available by prescription, to OTC status on September 1, 2005. On July 22, 2004, Barr Pharmaceuticals submitted a formal response (DOC-28K) to the FDA in support of its application for dual access to Plan B: non-prescription for women 16 years and older and prescription-only for women under 16. Click here for a recent Alan Guttmacher Institute review of the proposed age restriction for Plan B.
However, days before the expected decision, on August 26, 2005, the FDA issued a surprise notice that a decision regarding the application would be delayed. Instead, the FDA said it would begin another regulatory process, thereby delaying the decision indefinitely. The FDA plans to hold a new 60-day public comment period with no explicit timetable for a final decision. Click here to read the statement issued by the FDA (DOC-40K). Barr Pharmaceuticals issued a press release (DOC-32K) in response to the FDA’s announcement. As a direct result of the recent delay on a decision, Susan Wood resigned from her post as assistant FDA commissioner for women’s health and director of the Office of Women’s Health. Click here to read Ms. Wood’s correspondence sent to colleagues and women’s health advocates (PDF-28K). On September 6, the Government Accountability Office (GAO) said that in October, it will release findings from its investigation into why FDA last year rejected an application to switch the emergency contraceptive Plan B from prescription to OTC status.
Then, on September 23, 2005, Lester Crawford resigned from his position as Commissioner of the Food and Drug Administration (FDA). Click here to read the statement issued by Lester Crawford (PDF-28K).
On June 15, 2005, the Senate Health, Education, Labor & Pensions Committee approved the nomination of acting FDA Commissioner Lester Crawford to lead the agency. Following the vote, Senators Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) moved to block a full Senate vote on Crawford’s nomination due to the delay in issuing a decision on the Plan B application. Later, Senator Tom Coburn (R-Okla.) noted that he would place a hold on Crawford’s nomination until the FDA required that condom labels clarify the effectiveness in preventing pregnancy and sexually transmitted infections. Senators Clinton and Murray lifted their hold in mid-July after Secretary of Health and Human Services Michael Leavitt indicated that a decision on Plan B's OTC application would be made. Crawford was confirmed soon after.
A decision on dual access was expected in January 2005, however the FDA informed Barr that it was unable to complete its review of the application. View response
(PDF-20K) from Pharmacy Access Partnership. Barr had received
a Not-Approvable letter on May 6, 2004 for its application for OTC
access for women of all ages.
For more information about the FDA’s decision
in May, view the letter from
the FDA (PDF-171K), Barr
Laboratories press release (DOC-29K), an AP
news story (DOC-21K), and Pharmacy
Access Partnership's press release (DOC-90K). Releases were
also distributed by the Republican
Majority for Choice and the WISH
List Women In the Senate and House (PDF-436K).
The application to change Plan B to OTC status
was first submitted in April 2003 and the FDA officially filed the
application on June 20, 2003.
On December 16, 2003 a joint meeting of the FDA Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs voted 23-4 to recommend that Plan B be available OTC. Click here
(PDF-440K) for the meeting agenda. For an account of the meeting, view reports prepared by the FDA Advisory Committee, Pharmacy
Access Partnership (PDF-48K), Physicians
for Reproductive Choice (PDF-292K), and American
Pharmacists Association (DOC-32K). Barr Laboratories, maker
of Plan B, and experts with relevant experience testified and the
general public also submitted written and oral comments. The committees’
recommendation is non-binding to the FDA staff. View
Archive of Hearing Via Webcast.
The FDA was expected to announce its decision
on the OTC request on February 20, 2004, but on February 13, 2004
announced it would extend its deadline until May 21, 2004 to permit
review of additional data on adolescent use that was submitted by
Barr Pharmaceuticals, Inc and Women's Capital Corporation in support
of the application.
Because of EC’s proven safety, and its public health importance, many organizations have endorsed OTC availability of emergency contraceptives, including the American
College of Obstetricians and Gynecologists (PDF-448K), the American Medical Association, and the American Public Health Association. Providers are assessing the impact of EC going OTC. Click to read observations from the American
Medical Association and the New
England Journal of Medicine.
49 House Republicans, led by David Weldon, R-Fla., have written President Bush to urge that the FDA reject its advisory committee's recommendation to make Plan B available OTC. However, the American
College of Obstetricians and Gynecologists as well as several
Congressional
Democrats responded with letters of support for the switch.
The events and debate have raised considerable media
coverage.
How does improving access at the state level fit in with national efforts to deregulate EC? ?State level changes that allow pharmacists to initiate emergency contraception are highly synergistic with national efforts to gain OTC status.? says Sharon Camp, PhD, founder of WCC, the company that initially made Plan B and applied for OTC status. ?Only the FDA can switch a drug status from prescription to OTC, but states have considerable authority. If enough states grant direct pharmacy access to EC, the OTC switch becomes inevitable. The effort to take Plan B OTC should also help support state-level initiatives by making deregulation an important national issue.?
Sharon Camp directed the development of the
FDA application an effort that spans 59 volumes and 15,000
pages. The application includes two key studies the label
comprehension study and the actual use study. The actual use study
appears in the July 2003 issue of Obstetrics & Gynecology.
The packaging for Plan B is highly regarded for its straight forward
and easy to understand information.
Since its introduction in 1999, Plan B has become the standard product initiated by pharmacists in states that allow direct pharmacy access. For more information on state-level pharmacy access, visit www.pharmacyaccess.org/ECOTCStatus.htm or read this recent Women’s enews story. Plan B is the only progestin-only emergency contraceptive approved by the FDA. Progestin-only EC produces significantly less nausea than other emergency contraceptives containing both progestin and estrogen. In California, study data shows that over 95% of the EC provided by pharmacists is Plan B.
In 2001, a separate nonprofit group, the
Center for Reproductive Rights, also petitioned the FDA to change
emergency contraception from prescription to over the counter. This
citizens petition generated considerable media
interest and support across the country.
Interestingly, in 1997, before a dedicated EC
product was ever brought to market, the FDA noted in the federal
register (DOC-82K) that EC was safe and effective and called
on drug manufacturers to apply to make it available.
2001 PETITIONERS
Advocates for Youth
The Alaska Emergency Contraceptive Project
American Association of University Women
American Academy of Pediatrics
American College of Nurse-Midwives
Americans for Democratic Action
American Medical Womens Association
The American Nurses Association
American Public Health Association
American Society for Emergency Contraception
American Society for Reproductive Medicine
Arizona Family Planning Council
Association of Reproductive Health Professionals
Beaverhead Family Planning Clinic
Center for Entrepreneurship in International Health and Development, School of Public Health, University of California, Berkeley
Center for Womens Policy Studies
Choice USA
The Compton Foundation
The Consortium for Emergency Contraception
Family Health Care, Inc.
Family Health International
Family Planning Association of Northern Ohio, Inc.
Family Planning Council
Family Planning Councils of America
Family Planning Council of Iowa
Family Planning Association of Maine
Family Tree Clinic
Fargo Cass Public Health
Health Care of Southeast Massachusetts
Health Quarters
Ipas
Juneau Pro-Choice Coalition
Lake County Family Planning
Medical and Health Research Association of New York City, Inc
National Abortion Federation
National Abortion and Reproductive Rights Action League
California Abortion and Reproductive Rights Action League
Massachusetts Abortion and Reproductive Rights Action League
Minnesota Abortion and Reproductive Rights Action League
New York Abortion and Reproductive Rights Action League
National Asian Womens Health Organization
National Association of Nurse Practitioners in Womens Health
National Black Womens Health Project
National Coalition Against Domestic Violence
National Consumers League
National Family Planning and Reproductive Health Association
The National Organization for Women Legal Defense and Education Fund
The National Organization on Adolescent Pregnancy, Parenting & Prevention
National Partnership for Women and Families
National Women's Law Center
Okanogan Family Planning
Oops- Emergency Contraception Hotline
Oregon Medical Association
Pacific Institute for Womens Health
Pathfinder International
Physicians for Reproductive Choice and Health
Planned Parenthood Federation of America and all Planned Parenthood Affiliates Nationwide
Planned Parenthood of Central Washington
Planned Parenthood/ Chicago Area
Planned Parenthood of Connecticut
Planned Parenthood Heart of Illinois
Planned Parenthood of Houston and Southeast Texas, Inc
Planned Parenthood Association of Lubbock
Planned Parenthood of Nassau County
Planned Parenthood of the Saint Louis Region
Planned Parenthood of Southern Arizona
Planned Parenthood of Stark County
Planned Parenthood of the Texas Capital Region
Planned Parenthood of Western Washington
The Population Council
Population Services International, U.S. Programs
Pro Choice Resource Center
Program for Appropriate Technology in Health
Religious Coalition for Reproductive Choice
Robert Sterling Clark Foundation
The Reproductive Health Technologies Project
The Sexuality Information and Education Council of the United States
Society for Adolescent Medicine
Texas Family Planning Association
Tri City Health Center
Voters for Choice
Womens Health Center of West Virginia
Zero Population Growth, Inc.
OPTIONS FOR GETTING INVOLVED IN EC OTC INITIATIVE
Professional Education
- Initiate teleconference call to discuss EC
OTC with the leadership/advocacy network of organizations where
you are employed or with which you are otherwise affiliated. Identify
ways to educate these networks, the organizations constituency
on EC OTC, and additional ways to engage them.
- Develop policy position in support of EC OTC.
- Sponsor EC OTC resolution/policy during meetings of professional organizations.
Communications
- Post information about EC and OTC efforts
on website.
- Submit articles in support of EC OTC to Commentary,
Letters to the Editor, or policy update sections of
professional journals and newsletters.
- Suggest including educational information
and articles on EC OTC in the communications outlets of professional
organizations, businesses, and state and local government entities.
Venues for communicating this information include professional
journals, magazines, electronic or postal newsletters, discussion
boards, and conferences and upcoming meetings. Suggested topics
for articles include but are not limited to:
- FDA process for OTC applications
- Safety and efficacy profile of EC
- EC as a way to address the public health
problem of unintended pregnancy
- EC as the anti-abortion pill
- Awareness and use of EC (Kaiser Family
Foundation 2003 Survey)
- Pharmacy Access Programs
- Pharmacy protocols
- Federal and or state legislative efforts
around EC OTC
- Periodic updates on OTC application leading
up to FDA decision
Expand Network of EC OTC Supporters
- Contact colleagues in your organizations
national office to increase its involvement
- Contact colleagues in other states who may
also be interested in getting involved in efforts
- Advise on approach and contacts with their
national offices
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