FDA signals shift in birth-control debate

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 nonprescription 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. Males 17 and 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 California and eight other states, specially trained pharmacists are already allowed to provide the drug to females younger than 18 without a prescription. Previous studies have found that only about 25% 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 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 healthcare workers to deny services that violate their moral beliefs.

Both changes were top priorities of family-planning advocates and women’s groups, who had charged that the Bush administration was 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 Northup, 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.

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, 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 morning-after 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 $20 to $50.

Studies show that as many as 89% 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.

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 that the pill was safe.

But amid stiff opposition from socially 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 R. 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-years-olds can use Plan B safely without a prescription.”

--

noam.levey@latimes.com