Plan B pill approved at age 17 and up

saathi · Apr 24th, 2009, 01:37 pm

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WASHINGTON -- The Food and Drug Administration announced Wednesday that it would allow 17-year-olds to buy the emergency contraceptive pill Plan B without a prescription, signaling a major shift in the agency's approach to what has been a polarizing debate on reproductive rights.

The decision follows a ruling last month from a federal judge who rejected a Bush administration policy that allowed non-prescription sales of the pill only to people 18 or older, requiring younger girls to consult a doctor before they could get it.

The FDA said in a statement Wednesday that it would not appeal the judge's decision and would support expanded marketing of Plan B to 17 year olds upon receipt of a request from the drug's manufacturer. Men 17 an older could also buy the drug for their partners.

With its decision not to appeal, the FDA also implicitly agreed to follow the judge's order that it review whether to remove all restrictions on age and where the drug could be sold.

In nine states, specially trained pharmacists are already allowed to provide the drug to women under the age of 18 without a prescription. Previous studies have found that only about 25 percent of pharmacies in the state provide such a service.

The FDA's announcement was another example of the new priorities of the Obama administration, which in the last three months has moved to reverse several controversial Bush-era restrictions on family planning services.

Obama overturned a ban on U.S. support to international aid groups that provide abortion services and threw out a rule allowing health-care workers to deny services that violated their moral beliefs.

Both changes were top priorities of family planning advocates and women's groups, who had charged the Bush administration of politicizing the practice of medicine.

The groups also accused the FDA of letting politics dictate scientific policy in restricting use of the Plan B pill.

On Wednesday, Nancy Northrup, president of the Center for Reproductive Rights praised the agency's apparent change of heart.

"We commend the FDA for taking swift action to ensure that its decisions on Plan B are based solely on the drug's safety and efficacy," said Northup, whose group had brought the suit against the FDA. "It is a key step for the agency as it seeks to restore confidence in its ability to safeguard public health and leave politics at the lab door."

But conservative groups, concerned that the pill would only encourage promiscuity and more abortions, warned of abuses by teenage girls.

"Some minor girls will be able to obtain this drug without any guidance from a doctor or without any parental supervision," said Chris Gacek, Senior Fellow for Regulatory Affairs at the Family Research Council.

Dr. Charmaine Yoest, president and chief executive of Americans United for Life, said the FDA had "abdicated its responsibility" by failing to appeal the ruling.

Plan B, which is popularly known as the "morning after pill," is a concentrated dose of regular birth control pills. It does not end an established pregnancy like the controversial drug mifepristone, or RU-486.

The drug, which consists of two pills taken 12 hours apart, works largely by preventing ovulation. It may also make it harder for sperm to fertilize any egg by thickening mucus secretions, and it may inhibit implantation by affecting the uterine lining. One treatment costs between $20 to $50.

Studies show as many as 89 percent of pregnancies can be averted if Plan B is taken within three days of intercourse.

Family planning advocates have long endorsed the pill's use, arguing that it could reduce unplanned pregnancies and abortions.

But the pill's fate became one of the most politically charged scientific debates of the last administration.

The manufacturer of Plan B, Barr Pharmaceuticals Inc., originally petitioned the FDA for approval to sell it over the counter in 2003.

And ultimately, two independent scientific advisory committees that reviewed the issue for the FDA concluded the pill was safe for use by patients.

But amid stiff opposition from social conservative interest groups and members of Congress, the FDA did not approve Barr's request until 2006.

At that time, the agency said there was too little data to support over-the-counter sale of the pill to teenagers under 18.

The Center for Reproductive Rights had earlier filed suit in federal court, alleging that the agency was not abiding by its own regulations.

Last month, U.S. District Judge Edward Korman issued his ruling: a blistering 52-page broadside directed at the agency.

Korman accused the FDA of "political considerations, delays, and implausible justifications for decision-making." And he charged that the agency's decision to put an age limitation on the marketing of the pill "lacks all credibility."

"No useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription," he concluded. "Indeed, the record shows that FDA officials and staff both agreed that 17-year-olds can use Plan B safely without a prescription."

http://www.chron.com/disp/story.mpl/...e/6387744.html

do u think this will lead to more underage sex ? obama reversed bush's 8 year policy of plan b pills for 18 and older .

sara · Apr 24th, 2009, 01:44 pm

Where the world is coming to !

Quote:

The Food and Drug Administration announced Wednesday that it would allow 17-year-olds to buy the emergency contraceptive pill Plan B without a prescription, signaling a major shift in the agency's approach to what has been a polarizing debate on reproductive rights.