Aug. 24 (Bloomberg) -- Barr Pharmaceuticals Inc. won U.S. approval to sell its ``morning after'' contraceptive pill without a prescription, capping a policy debate that has dogged the Bush administration for three years.

The Food and Drug Administration said today that customers must show that they are 18 or older to buy the pill, similar to the restriction for buying cigarettes. The drug, called Plan B, is designed to prevent pregnancy when taken within 72 hours after sex. Those younger than 18 still need a prescription.

The end of the battle removes an obstacle to the confirmation of Andrew von Eschenbach as FDA commissioner. Democratic Senators Hillary Clinton of New York and Patty Murray of Washington said that they will no longer block the appointment. Barr's application to sell Plan B without a prescription set off a debate between those who said access to the drug is important for health and social conservatives who argued it might increase teenage sexual promiscuity.

``We are very pleased about this decision,'' Clinton told reporters on a conference call. ``It is an important step forward, and it is about something more than just Plan B. The non-decision out of FDA was about the integrity of the agency as a whole.''

President George W. Bush ``agrees that minors should have a prescription,'' spokeswoman Dana Perino told reporters today. Bush understands that the FDA ``did an exhaustive review, that they recognized the critical distinction between minors and adults, and the risks this drug can impose.''

Availability

Shares of Woodcliff Lake, New Jersey-based Barr fell by 20 cents to $57.77 at 4:02 p.m. in New York Stock Exchange composite trading. The shares are up 28 percent since mid-July, buoyed by a jump in fiscal fourth-quarter earnings.

Barr aims to make the non-prescription pill available as early as Nov. 1, Chief Executive Officer Bruce Downey said today in an interview. It will only be sold in pharmacies or clinics. Customers will have to ask for the pills.

It will be up to Barr and drug stores to enforce the FDA age restriction, because the agency says it doesn't have legal authority to do so. Barr said it will send undercover shoppers to ensure pharmacies are checking for identification and report any violations to state pharmacy boards.

Walgreen Co., the biggest U.S. drugstore chain by revenue, said it will begin selling Plan B over the counter once Barr changes its packaging. Customers will have to show proof of age, spokeswoman Carol Hively said in an e-mailed statement.

Sales

Plan B sales may double from about $30 million last year, said Barr Chief Executive Officer Bruce Downey in an interview today. The over-the-counter version may cost slightly more than the prescription version, which sells for between $25 and $40.

``It accounts for 100 percent of our publicity, about 3 percent of sales,'' Downey said, adding that his company will continue to seek to end age restrictions.

The approval will have little impact on Barr's earnings, said Ken Cacciatore, an analyst at Cowen & Co. in New York, in an interview. The agreement ``has tons of political implications and less of an impact on Barr,'' he said.

Opponents of the compromise threatened to take legal action. Some advocates wanted no age limits, saying wider availability will prevent unintended pregnancies. On the other side were those who said any over-the-counter sale would increase promiscuity.

Elections

The Family Research Council, a group of social conservatives, said in its statement it would pursue legal and legislative options. The Morning-After Pill Conspiracy, which describes itself as a coalition of feminist groups, has also filed a lawsuit opposing the age restrictions.

People on both sides of the debate said that lawmakers' efforts to block von Eschenbach's nomination as permanent commissioner probably forced the agency to act.

``Von Eschenbach did this out of his desire to get confirmed,'' said Wendy Wright, whose Washington-based group, Concerned Women for America, has long opposed Plan B sales without a prescription. ``People should lose a lot of confidence in the FDA over this.''

The FDA's approval after three years of delays is likely to be an issue in this year's congressional election campaigns, said Carl Tobias, a law professor at the University of Richmond Law School who was a legal consultant to the FDA in the 1970s.

``There's been a lot of strong opposition,'' Tobias said. ``There are a lot of issues swirling around about whether decisions are being made for reasons of science or politics.''

End of an Era

The battle over Plan B subjected the FDA to widespread criticism. At least one high-level FDA official resigned in protest over the delays.

``The credibility of FDA has been at stake over this and it remains at risk,'' said Susan Wood, who resigned a year ago as FDA assistant commissioner of women's health. ``This is a move to help restore its credibility and restore the reputation it has long had of being a science-based agency.''

An agency advisory panel had recommended approval of Barr's application to sell the drug to all age groups without a prescription. The FDA rejected that approach, saying there wasn't enough evidence young teens could safely use Plan B without a doctor's supervision.

Barr then asked the agency for permission to sell Plan B to those 16 and older. Last August, the FDA said it thought sales should be limited to those 17 and older and delayed a decision indefinitely while it sought public comment.

Europe's Plan B

Levonelle, the European equivalent, is available without prescription in the United Kingdom to women 16 and older, said Astrid Kranz, a spokeswoman for Schering AG. The German company has a marketing agreement in several European Union countries with Gedeon Richter Nyrt, the Hungarian pharmaceutical company that makes Plan B for Barr.

Zsuzsa Beke, a spokeswoman for Richter, said the drug usually is available by prescription only.

Richter, eastern Europe's biggest drugmaker by stock market value, added 1.7 percent to close at 46,980 forint in Budapest.

Plan B contains high doses of an ingredient used in prescription birth control pills. The drug is effective if women take the first of two pills as soon as possible within 72 hours of sex. The second pill is taken 12 hours later.

To contact the reporters on this story: Justin Blum in Washington at jblum4@bloomberg.net; Shannon Pettypiece in Washington at (1) spettypiece@bloomberg.net

Last Updated: August 24, 2006 17:48 EDT