Over the Counter Sales of Emergency Contraceptive Pills Allowed by FDA for 17 Year olds
Over the Counter Sales of Emergency Contraceptive Pills Allowed by FDA for 17 Ye

The Food and Drug Administration said Wednesday that the "morning-after pill" will be available without prescription to 17 year olds and older. Till now the FDA approved the sale of Plan B without a prescription to those 18 and older and the change is in response to a federal judge's directive.

The "morning after pill" is an emergency birth control pill that in 2006 the FDA had decided to limit over the counter sales of to women 18 or older. On March 23, U. S. District Judge Edward R. Korman ordered the agency to evaluate the lifting of age restrictions and ruled that 17 year olds be allowed to get the drug without a prescription.

The agency in a statement on its Web site they will not appeal that order. "On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription.

The government will not appeal this decision. In accordance with the court's order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

Korman said the FDA had deviated from their own procedures in regards to making a decision on the pills availability as an over the counter drug and said there was "unusual involvement of the White House in the Plan B decision-making process." "No useful purpose would be served by continuing to deprive 17-year-olds access to Plan B without a prescription," Korman wrote in his order. "Indeed, the record shows that FDA officials and staff both agreed that 17-year-olds can use Plan B safely without a prescription.

The FDA's justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility." Plan B which is essentially an extra high dose of birth control is used as an emergency contraceptive and needs to be taken within 72 hours of unprotected intercourse to be effective.

Although the drug prevents pregnancy by delaying ovulation, religious conservatives object to its usage saying its equivalent to an abortion pill and feel it could encourage premarital sex. Supporters say the pill is safe and effective in controlling unwanted pregnancy and reducing abortions.

They also believe that limiting the availability of the pill to those 18 and older was in deference to the conservative views of then-President George W. Bush and his administration. The FDA originally approved Plan B manufactured by Duramed Research Inc. of Bala Cynwyd, Pa. as a prescription drug in 1999. In August 2006, after three years of delay when the FDA announced the approval of over the counter sale of Plan B pill Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said, "Our assessment is that this younger age group would strongly benefit from consultation with a health-care provider before using the product.

The application did not contain enough information about this age group to make us comfortable to do the switch fully for those younger people." Planned Parenthood Federation of America President Cecile Richards called the FDA's announcement" a strong statement to American women that their health comes before politics. And that's the way it should be.

This decision is common-sense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women."

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