Over-the-counter answer when what seemed so right meets the morning after

Tuesday, Aug. 15, 2006 | 7 a.m.

It could become a familiar ritual, here in Sin City, or maybe just a bad television commercial.

An attractive young woman awakes in a hotel room, a view of the Strip outside her window. She glances to the floor and notices an unfamiliar pair of jeans. Perplexed expression on her face, she turns to see a man she barely recognizes asleep next to her.

She buries her head in her hands as a fuzzy recollection of the previous night slowly returns.

Suddenly she removes her hands, an enlightened grin spreading across her face as she says, "Time for Plan B."

She goes to a nearby pharmacy, shows her driver's license and leaves with two pills and a smile on her face.

If, as expected, the Food and Drug Administration approves over-the-counter sales of the Plan B or "morning after" pill in the next few weeks, it could give a whole new meaning to the slogan "What happens here, stays here."

Plan B (levonorgestrel) is the emergency contraception pill that greatly reduces the chance for pregnancy. Unlike RU-486, the so-called abortion pill, Plan B does not affect an existing pregnancy but can prevent a pregnancy from occurring if taken within 72 hours.

The pill is marketed to be used "when things don't go as planned." That might mean unprotected sex, or maybe the failure of a contraceptive device, such as a condom.

Whatever the reason, a pill that can stop an unwanted pregnancy figures to be a big hit in a town that promotes sex almost as much as slots.

The pill has been available by prescription since 1999.

Dr. Cary Logan of Inn-House Doctor, a concierge physician service for local hotel guests, insists on examining a patient before he will prescribe the medication, however. Logan will occasionally prescribe a few blood pressure pills by phone for a patient that has forgotten the medication, but not the Plan B pill.

"I want to make sure the person I am prescribing it for is the person who takes it," he explained.

FDA officials acknowledge that this has been a key stumbling block to approving Plan B for over-the-counter use.

Duramed Research Inc., a subsidiary of Barr Pharmaceuticals, first requested permission to sell the drug without a prescription in April 2003, and an FDA panel recommended approval later that year. The agency later ruled, however, that the pill was "not approvable" for over-the-counter sale because of concerns over its accessibility to teens.

It has been a political hot potato since, with Democratic Sens. Hillary Clinton of New York and Patty Murray of Washington twice vowing to block the appointment of an FDA commissioner if the agency did not approve over-the-counter sales.

In 2005 the two senators lifted a hold on Lester Crawford's FDA nomination after Health and Human Services Secretary Michael Leavitt promised to make a decision on the drug. Crawford was later confirmed by the Senate, but the FDA refused to approve the pill for over-the-counter sales, citing concerns over enforcement of age restrictions.

Crawford resigned last year, and Clinton and Murray placed a similar block on Andrew von Eschenbach, the current nominee , in March.

Just when it appeared the issue was at an impasse, the FDA said the enforcement rules weren't necessary and last month invited Barr Pharmaceuticals to resubmit its application.

The FDA expressed confidence the two sides could work out an acceptable framework for nonprescription sales in a matter of weeks.

That, however, doesn't mean the pills will be available in the hotel gift shop .

To allay its worries, the FDA has asked that the amended application restrict sales to women over 18 and that the pill be sold only in pharmacies and kept behind the counter.

"We have concerns that women of all ages understand how to use this drug and that the directions are followed," said Susan Bro, a spokeswoman for the FDA. "That includes directions on how and when to consult a physician."

Loretta Holt, president of the Sin City Chamber of Commerce, a Las Vegas organization that claims on its Web site to promote "businesses that make Las Vegas the most exciting city in the world," expressed support for widespread sale of the pill, but she questioned whether its impact would be greater here than elsewhere.

"Women should be left to their own discretion whether this is necessary. It will probably be used by a cross section of women across the country. That scene goes on all over."

Tiffani Bruce, spokeswoman for Walgreens Pharmacy, admitted that some markets are riper for sales of the pill than others.

"We have places where we have never sold a single (Plan B) pill."

She laughingly acknowledged, however, that Las Vegas was definitely not one of those places.

For its part, manufacturer Barr is playing it close to the vest when it comes to marketing strategy .

No doubt. The company does not want to do anything to derail the drug's long-awaited over-the-counter approval.

Here's hoping that whatever its plans, Barr doesn't have Maureen McGovern singing "There's Got to Be a Morning After" at the end of its commercials.