Emergency Contraception for all Ages without Prescription-Court ruling erupts controversy:

Jojy Cheriyan MD;MPH-April05,2013

A federal judge, of US District Court in Brooklyn New York, today (April05,2013) ordered the Food and Drug Administration(FDA) to make "morning-after" emergency contraception pills available without a prescription to all girls of reproductive age.

Currently, only women over 17 years age can buy emergency contraception pill without prescription from any pharmacies by presenting an identification proof to a pharmacist.

The ruling is a victory for reproductive rights groups who had been seeking removal of age restriction and all other restrictions on emergency contraception.

The Center for Reproductive Rights and other groups had petitioned the FDA to strike down age and access limits on all emergency contraceptives, saying there was no scientific proof that girls younger than 17 could not safely use the drug without supervision.

Teva Pharmaceuticals Ltd, which introduced emergency contraceptive pills for the first time in 1999, had also petitioned the government to allow sales of Plan B One-Step over the counter pill without restrictions. Plan B One Step (Levonorgestrel 1.5 mg, a synthetic hormone) is a single-pill version to be taken within 72 hours (3-days - 89% success rate) after sex and is marketed widely in US. It is most effective if taken within 24 hours (95%).

This pill works in 2 ways- (1) by delaying ovulation- so ovary will not release egg or (2) if fertilization occurs, this One-Step pill may prevent a fertilized egg from embedding in the uterus. But if the egg has already been implanted in the uterus, the morning-after pill will not work. It does not protect you against sexually transmitted diseases like HIV. It is not for routine use and that is why it is called Plan B. It does not stop development of a fetus once the fertilized egg implants in the uterus. So it will not work if you are already pregnant when you take it.

In 2011, the FDA said it had concluded Plan B One-Step could be safely used in girls of child-bearing age. But U.S. Department of Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled the FDA and said that there was insufficient evidence to support removing the restrictions. Therefore FDA also rejected the petitions to lower the restrictions.

The American College of Obstetricians and Gynecologists (ACOG) recommended last year that oral contraceptives be sold over the counter in an effort to reduce the number of unintended pregnancies in the United States. A 2012 study in the journal Pediatrics found that there is misinformation about emergency contraception, including about what age women can obtain it without a prescription, and who can take it in general.

In today's verdict the judge Edward Korman blasted FDA calling the agency's action as arbitrary, capricious and unreasonable.

But the Family Research Council expressed concerns about the order."There is a real danger that Plan B may be given to young girls, under coercion or without their consent. The involvement of parents and medical professionals act as a safeguard for these young girls. However, today's ruling removes these commonsense protections," Anna Higgins, director of the organization's Center for Human Dignity, said in a statement.

FDA said today that it couldn't comment as this is an ongoing legal issue and more statements and comments can be expected from prolife groups in the coming days.

For more breaking updates in health go to http://jpmnews.com/health.php

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