Teva treads lightly in morning-after controversy

The recent controversy surrounding the morning-after contraceptive pill called Plan B One-Step has been argued in political, regulatory, and legal circles. But Teva Pharmaceuticals Ltd., which makes the drug and has its Americas headquarters in Montgomery County, has largely succeeded in remaining a bit player in the swirling theatrics.

For several years, Teva's drug and generic versions of morning-after pills have been available to females 17 or older without a prescription.

On April 5, Brooklyn, N.Y., a federal judge, Edward Korman, ordered that contraceptives approved by the Food and Drug Administration for sale without a prescription be made available to women of any age. On Monday, the U.S. Court of Appeals for the Second Circuit in Manhattan extended a stay of Korman's order. A resolution is unlikely before June.

Some of Teva's quiet approach relates to the touchy subject. "As a publicly traded company, they have to take that into consideration," said St. Joseph's University pharmaceutical and health-care marketing professor George Sillup.

Some of the strategy appears related to a deal Teva managed to strike with the FDA on April 30 that would make Teva's contraceptive more accessible to consumers on drugstore shelves. Some of the strategy seems related to the financial relevance of Plan B One-Step.

IMS Health, a health-care technology and information company, said that Plan B One-Step had $82 million in sales in 2012. The product was not mentioned at all during the May 2 conference call between company officials and Wall Street analysts, where the billion-dollar multiple sclerosis drug Copaxone dominated discussion.

"Some business is just not worth the trouble," said Erik Gordon, a University of Michigan business professor who follows the pharmaceutical industry. "You make 5 cents and get a punch in the nose. Plan B isn't the only example."

In December 2011 - after more than a decade of urging by women's health groups hoping to reduce unwanted pregnancies - the FDA approved Teva's Plan B One-Step for women of all ages without a prescription. But Health and Human Services Secretary Kathleen Sebelius overruled, the first such decision of its kind in agency history. President Obama agreed with her decision.

The next event was Korman's April 5 ruling, though the Justice Department appealed the decision.

Then on April 30, the FDA approved only Teva's Plan B One-Step for women 15 or older without a prescription. The FDA made a point of saying it had nothing to do with Korman's earlier order and his scathing critique of Sebelius for intervening.

"We welcome the FDA's decision to provide extended and improved access to this important product, a significant milestone for women," Marty Berndt, a vice president with Teva Women's Health, said in a statement April 30.

If Teva once sided with Korman for unlimited access, it is not pressing the case now. As Korman noted in a filing last week, because of the "sweetheart" deal with the FDA announced April 30, only Teva's product will be on the shelves and available to females 15 and older for three years.