DEMAND FDA ACTION ON PLAN B

From: Public Policy Department, NFPRHA
Date: October 14, 2005

On August 26th the U.S. Food and Drug Administration (FDA) announced that it would not approve a revised application to make Plan B emergency contraception (EC) available over-the-counter (OTC). Claiming to need even more input before making a decision, the FDA initiated a 60-day public comment period which ends on November 1. There is absolutely no scientific justification for denying women over-the-counter access to this safe and effective method of contraception.

PLEASE TAKE ACTION TODAY:

There are two things you can do:
1) Sign the petition from Senators Hillary Clinton (NY) and Patty Murray (WA) demanding FDA action on Plan B. Senator Clinton's office will print out the letter with all of the signatures and submit them to the FDA. Sign up today at
http://clinton.senate.gov/issues/women/index.cfm?topic=planbpetition

2) Send an individual letter to the FDA urging that they heed science, promote public health and approve the application to make Plan B emergency contraception available over-the-counter!! You can send a letter directly from our website at www.nfprha.org

BACKGROUND

On August 26th the U.S. Food and Drug Administration (FDA) announced that it would not approve a revised application to make Plan B emergency contraception (EC) available over-the-counter (OTC). This marks the second time the FDA has ignored the overwhelming scientific evidence in favor of switching the status of Plan B from prescription to over-the-counter. The original application on Plan B was rejected in May 2004. In the latest announcement, the FDA sidestepped its obligation to act on the scientific evidence specific to the Plan B application and created a new roadblock in the Plan B application process. Claiming to need even more input before making a decision, the FDA initiated a 60-day public comment period which ends on November 1.
There is absolutely no scientific justification for denying women over-the-counter access to this safe and effective method of contraception. Further, from a public health perspective, the case for FDA approval is compelling. Emergency contraception holds great potential for helping to prevent unintended pregnancy and reduce the need for abortion. Widespread use could prevent as many as half of the three million unintended pregnancies in the U.S. each year, including as many as 700,000 that now end in abortion. The FDA's latest decision represents a lost opportunity for common sense and common ground.

The Case for Making Plan B Available OTC

Removing barriers to EC use enables more women and teens to prevent unintended pregnancy. Speed is critical to maximize the effectiveness of EC. Although recent studies confirm that EC can work up to 5 days after unprotected sex, if taken within 72 hours of intercourse, EC can reduce the risk of pregnancy by as much as 89 percent and efficacy is greatest if the drug is taken within 24 hours. But in most states, women need a doctor's prescription to buy EC. The ACOG noted that the need to obtain a prescription from a doctor is one of the biggest barriers to EC use.
EC use will reduce the number of abortions, it cannot cause them. Arguments that Plan B emergency contraception causes abortions are completely false. Emergency contraceptive pills are simply specific concentrated doses of ordinary birth control pills and work the same way - EC cannot interrupt or disrupt an established pregnancy and should not be confused with Mifeprex, the abortion pill.
Imposing an age restriction on OTC access is medically and scientifically unjustified. Studies confirm that OTC access for teens poses no health risk to young women and does not lead to more unprotected sex or an increased risk of sexually transmitted disease. Further, as medical professionals attested, the concerns about health risks associated with unintended pregnancy among young women far outweigh any perceived notion of risk association with EC use.