By Lewis Krauskopf,The Record (Hackenack, N.J.)

HACKENACK, N.J. – The fate of Plan B, the emergency contraceptive, has been swamped in political controversy during the past 20 months.

Not that that’s necessarily all bad for its marketer, Barr Pharmaceuticals Inc. of Woodcliff Lake, N.J.

Prescriptions of Plan B have shot up the past two years, even though the Food and Drug Administration has dragged its feet on Barr’s latest application to move Plan B to over-the-counter status.

The controversy over the FDA’s inaction and the ensuing media coverage has fed awareness of emergency contraception, company officials and analysts say. As the federal government has stalled, many states this year have introduced – and some passed – measures to improve access to emergency contraception. And Barr has also been putting some promotional muscle behind the product.

Barr figures to get an answer on its over-the-counter application soon. Last month, the Bush administration said the FDA would act on the application by Sept. 1. To force the FDA to make a decision, U.S. Sens. Hillary Clinton, D-N.Y., and Patty Murray, D-Wash., had blocked a vote to confirm acting FDA Commissioner Lester Crawford as permanent chief. After the Sept. 1 deadline was announced, the senators removed their block and the Senate confirmed Crawford last month.

If its application is approved, Barr would sell Plan B as an over-the-counter product to females 16 and older. The prescription requirement would remain for younger girls. But as recent trends demonstrate, Plan B could be on the rise regardless.

“I think there will be gradual growth in this product, whether it is over the counter or not,” said Carole Ben-Maimon, president and chief operating officer of Duramed Research, the subsidiary overseeing Barr’s proprietary products.

Twenty-one states introduced legislation to expand access to emergency contraception this year, according to the Planned Parenthood Federation of America.

Often called the “morning-after pill,” Plan B is essentially a high dose of birth-control pills. Plan B has shown it can reduce the risk of pregnancy by 89 percent if taken within 72 hours after unprotected sex. It is more effective the sooner it is taken after sex, leading Barr and many women’s advocacy groups to press for it to be moved over-the-counter to improve access.

One possible way Plan B works is by preventing a fertilized egg from implanting in the womb – tantamount to an abortion in the eyes of some opponents. Gov. Mitt Romney of Massachusetts used such an argument when he vetoed a bill last week that seeks to ease access to emergency contraception.

Barr is one of the country’s largest producers of generic drugs, including 22 brands of birth-control pills, and is expanding into patent-protected products.

The company said that 700,000 prescriptions for emergency contraceptive products were dispensed during the 12 months that ended in June – nearly twice as many as the same period two years ago. The statistics exclude Plan B dispensed at family planning clinics, a substantial part of the market. Barr formerly manufactured the other emergency contraceptive, Preven, for another company. Since March, the number of prescriptions written for Plan B has been steadily increasing, according to quarterly data from IMS Health, a pharmaceutical information company.

Barr projected Plan B sales of $20 million to $25 million in its fiscal year, which ended in June, about triple the level of two years ago.

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Barr took over Plan B officially in February 2004, when it completed its $21 million purchase of Women’s Capital Corp., a small, privately held firm that was established to develop and market reproductive health products.

Ben-Maimon said Barr has promoted Plan B to physicians through its 226 sales representatives, who primarily focus on two larger-selling products: its Seasonale birth-control pill and Cenestin hormone-replacement therapy. Barr also has lobbied at the state level for bills to improve access to Plan B, she said.

Sharon Camp, who ran Women’s Capital, said she was disappointed there hadn’t been a broad consumer ad campaign for Plan B.

“This really is a consumer pharmaceutical product that’s been trapped in a prescription status and needs to be marketed as if it’s over-the-counter,” said Camp, now the CEO of the Alan Guttmacher Institute, a non-profit focused on reproductive rights and sexual health.

Ben-Maimon said it wouldn’t make financial sense for Barr to launch a large and expensive consumer ad campaign for Plan B, which represents only about 2 percent of the company’s $1 billion in annual revenue.

Still, she says, the product fills an unmet medical need and is a good strategic fit for Barr and its focus on women’s health products. She said Barr’s effort to back non-prescription Plan B has engendered goodwill with several top medical groups that endorsed the switch.

Along with Seasonale, Barr’s new birth-control pill, Plan B “sort of put us on the map in the female health-care area,” Ben-Maimon said.

If the FDA rejects Barr’s OTC application, the company will focus more on increasing access at the state level, Ben-Maimon said.

“We’re totally committed to the product and to growing it,” she said.

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(c) 2005, North Jersey Media Group Inc.

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Distributed by Knight Ridder/Tribune Information Services.

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GRAPHIC (from KRT Graphics, 202-383-6064): 20050727 WN Plan B

AP-NY-08-05-05 0618EDT

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