Emergency Contraception Over-The-Counter

Despite a 23-4 recommendation by its own Advisory Committee, and despite recommendations from numerous health organizations including the American College of Obstetricians and Gynecologists (ACOG) and the American Public Health Association, the FDA rejected making Plan B® Emergency Contraception (EC) available over-the-counter on May 6, 2004.  After delaying its decision for several months, the FDA issued a Not Approvable Letter [.pdf] to Barr Pharmaceuticals citing insufficient data regarding safety in girls under age 16.

Barr subsequently submitted a revised application which would allow EC to be sold without a prescription to women aged 16 and over, but would require a prescription for women under 16 (Barr News Release, 7/22/04).  After the FDA delayed ruling on Barr's resubmission in January 2005 (Barr News Release, 1/21/05), Senators Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) blocked a full Senate vote on Lester Crawford's nomination to serve as the FDA commissioner until the FDA made a decision on EC (The Washington Post, 4/7/05).  On July 15, 2005, Department of Health and Human Services Secretary Mike Leavitt said the FDA would make a decision on Barr's application by September 1, 2005 (The New York Times, 7/16/05).  This announcement prompted Senators Clinton and Murray to lift their hold on Crawford's nomination (AP/Las Vegas Sun, 7/15/05) and Crawford was confirmed for the post on July 18, 2005 (AP/USA Today, 7/18/05).

The FDA Postpones Decision
On August 26, 2005, the FDA postponed making a decision on the status of Plan B®, instead requesting public comment for 60 days on three main issues:

1) Should the FDA clarify its rules (specifically section 503(b) of the Federal Food, Drug, and Cosmetic Act) regarding when an active ingredient can be sold both as a prescription drug and over-the-counter?

2) Would the FDA be able to enforce the sale of Plan B as OTC to a certain group and as a prescription drug to another? And would it be practical to do so?

3) Is it legal to sell both the OTC and the prescription drug in the same package?

Please see the FDA's website for more information on this decision, its letter to Barr Laboratories, and the comment submission procedure.

Resignations Ensue
On August 31, the director of the FDA's Office of Women's Health, Dr. Susan F. Wood, resigned in protest of the agency's handling of Plan B, saying that she can no longer serve at the FDA "when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled" (AP/CNN, 8/31/05).  On September 1, the American Academy of Pediatrics issued a detailed policy statement in support of over-the-counter status.  In an unexpected move, FDA Commissioner Lester Crawford resigned on September 23 (AP/CNN, 9/23/05).  Several Congressmen, including Senators Michael Enzi (R-WY) and Edward Kennedy (D-MA), called for a federal investigation into Crawford's sudden departure citing concerns over potential conflicts of interest regarding pharmaceutical company stock holdings (The Boston Globe, 9/29/05).

In early October, Frank Davidoff, MD, also resigned his post as a consultant to the FDA in light of the recent Plan B announcement.  Dr. Davidoff was a member of the FDA's Nonprescription Drugs Advisory Committee when it voted to approve Plan B for over-the-counter sales.  His sentiments upon departure were similar to Dr. Wood's, saying "There wasn't any observable scientific or procedural reason for them to first decline and then further delay the decision.  I had to make the inference this was a decision that was made on the basis of political pressure, and it seemed to me that was unacceptable" (AP/Hartford Courant, 10/6/05). 

The GAO Investigates
In November, the U.S. Government Accountability Office (GAO)--an independent, nonpartisan agency that works for Congress--issued a report investigating the FDA's first Plan B rejection.  This study, titled "Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual" [.pdf], found four atypical aspects of the May 6, 2004 decision:

  1. The directors of the offices that reviewed the application--inlcuding the Director of the Office of New Drugs--who would normally sign a not-approvable letter, did not sign the Plan B letter because they disagreed with the decision.
  2. The FDA's high-level management was more involved in this decision than in those of other OTC switch applications.
  3. There is conflict over whether the decision was made before the reviews were completed.
  4. The decision's rationale was novel:  "FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency previously has considered it scientifically appropriate to extrapolate data from older to younger adolescents."

The Plan B application was the only one of 67 proposed prescription-to-OTC switch applications from 1994-2004 that was not approved after the advisory committees recommended approval.

Following this GAO Report, Representative Henry Waxman (D-CA) requested a House Committee on Government Reform hearing on the FDA's Plan B decisions and "the influence of political and ideological considerations on the FDA's actions."  In his 11/15/05 letter [.pdf], Rep. Waxman cited the Plan B decision as "one particularly egregious example of the politicization of science."

ACOG Takes Action
On May 8, 2006, ACOG launched its "Ask Me" campaign aimed at encouraging women to request an advance EC prescription from their ob/gyn.  Since the FDA had still not ruled on the Plan B decision, ACOG was attempting to eliminate the political barriers to obtaining EC and bring the discussion back to the doctor's office.  According to ACOG President Dr. Michael Mennuti, "We want women to be prepared, well before a contraceptive failure or unprotected sex occurs. Afterward may be too late" (AP/The Washington Post, 5/8/06).

The FDA Makes A Move
On July 31, 2006, the FDA announced that it would open discussions with Duramed, a subsidiary of Barr Pharmaceuticals Inc., to move Plan B over-the-counter for women aged 18 and over.  This announcement came a day prior to a Senate committee hearing for the nomination of Dr. Andrew von Eschenbach to head the FDA.  Senators Clinton and Murray questioned the motives of the FDA announcement and pledged to maintain blocking Dr. von Eschenbach's confirmation until a decision regarding Plan B was made (AP/San Francisco Chronicle, 8/31/06).

On August 24, 2006, the FDA announced its decision to make Plan B available over-the-counter for women aged 18 and over.  (Plan B will remain a prescription drug for women aged 17 and under.)  Please see the FDA Drug Information webpage for more information about Plan B and this decision.


Bixby Center on EC:

EC Facts:

EC Info:

EC Studies:

EC Meetings:

  • "EC Knowledge among California Women" (UCSF, May 2005). Center researchers held a meeting to share recent data on women’s knowledge of EC in California. According to analysis from the California Women’s Health Survey (CWHS), there has been steady overall improvement in knowledge of EC since 1999 among California women of reproductive age. However, data demonstrate persistent disparities in knowledge of EC by race/ethnicity, socioeconomic status, and educational attainment.

Coming Soon: Controversies about Emergency Contraception (EC): The Scientific Evidence

The Bixby Center for Global Reproductive Health is completing a series of seven "briefs" that provide evidence-based responses to common myths and misinformation about EC. Topics include efficacy, safety, sexual risk behaviors, adolescent use, mechanism of action, over-the-counter availability, and cost-effectiveness. The briefs are intended for diverse audiences and summarize the scientific literature in user-friendly language.