Newsletter: Summer 2004: Time for Plan C?

The spring was a tumultuous time for New York City activists working to make Plan B (a brand of emergency contraception) readily available to all women who need it.

First, in late April, the New York City Council released a report that found that nearly one quarter of New York City Hospitals fail to offer emergency contraception to survivors of sexual assault.  

Almost simultaneously, the Food and Drug Administration (FDA) rejected over-the-counter sales of the emergency contraceptive Plan B, saying the distributor had not proved that young teenagers can take the drug safely without a doctor's guidance.  This was an unusual but unsurprising move.  In denying over-the-counter approval to Plan B, the FDA went against the decision of two of its own expert advisory panels both of which voted overwhelmingly that Plan B could be safely sold as an over-the-counter medication.

Plan B is produced by Barr Laboratories.  In rigorous clinical trials, Plan B has been proven to be a safe, effective, and easy to tolerate medication.  It is currently available over-the-counter in 33 countries.   If taken within 72 hours after having sex, Plan B dramatically reduces the chance that a woman will become pregnant.  A study by the World Health Organization study demonstrated that after a single act of unprotected sex, Plan B prevented 89% of expected pregnancies if taken within 72 hours. When used within 24 hours Plan B prevented 95% of expected pregnancies. In short, the sooner the pills are taken, the greater their efficacy.

For rape survivors, the Council’s findings and the FDA’s decision amount to injury on top of insult. In situations of rape, the process of finding a doctor and reporting the assault poses a huge barrier.  Not having ready access without a doctors’ prescription means many women cannot access the medication within 72 hours of their assault. Moreover, the Council’s report makes it clear that even if survivors do report in NYC emergency rooms, they might not receive Plan B:  seven New York City hospitals told City Council investigators that emergency contraception could not be provided in the emergency department, and six said that “they did not know” if their hospital provided emergency contraception to rape survivors.

The City Council report was released by City Council Speaker Gifford Miller, Council Member Christine Quinn, Chair of the Health Committee, Council Member Gioia, Chair of the Oversight and Investigations Committee and Council Member Eva Moskowitz.  In the wake of these findings, the report recommended that the FDA should approve Plan B for over-the-counter sale and that the NYS Senate pass its bill to allow nurses and pharmacists to dispense Emergency Contraception.

The FDA cited limited data on Plan B’s use by women ages 16 and under as its premise for denying approval for over-the-counter sales . The data is in fact limited because up until now, very few women from this age group have used Plan B.  However, more than 70 public health, medical, and women’s organizations have pointed out that the FDA’s mandate is to make risk-benefit decisions about the public’s health.  Even in light of limited data on women 16 and under, these allied organizations agree that it is clear that the public’s health is best served by over-the-counter access to emergency contraception.

Many opponents of the FDA’s decision not to allow over-the-counter sale of Plan B blame the decision on Dr. David Hager, chair of the FDA’s Reproductive Health Drugs Advisory Committee.  Following testimony about Plan B’s efficacy and safety before the FDA committees, Dr. Hager remarked, “What we heard today was frequently about individuals who did not want to take responsibility for their actions and wanted a medication to relieve those consequences.”  In fact, studies show that women use emergency contraception responsibly, and that they do not rely on it as a regular method of contraception.   

Planned Parenthood Federation of America, Inc. (PPFA) has denounced the decision as bad science, and criticized President Bush’s re-appointment of Dr. Hagar to the FDA committee.  PPFA National Medical Committee Chairman and University of Wisconsin-Madison Associate Professor of Pediatrics Dr. Scott Spear said: “Dr. Hager's ideological agenda compromises the scientific integrity of the FDA.”   He advised that “Americans rely on the FDA as a trusted and objective safeguard. President Bush has betrayed the public trust by installing a biased ideologue in a key scientific role. When science comes second, public health suffers.”

Barr Laboratories is currently pursuing two alternative approaches to over-the-counter approval as laid out by the FDA.  Those approaches include 1) providing additional data demonstrating that women 16 and under can use Plan B safely and 2) supplying information on how Plan B could be made available over-the-counter to women 16 years and older, by prescription only to women under 16. In speaking to the Washington Post, Barr CEO Bruce L. Downey, said he thought it would take "months rather than years" to come up with a new plan to gain FDA approval, making Plan B available over-the-counter.

Ms. Pollak is the Forensic Healthcare Program Director at the New York City Alliance Against Sexual Assault. [more]

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