Teva gets exclusive rights for OTC morning-after pill

Teva gets exclusive rights for OTC morning-after pill

PHILADELPHIA, July 26, 2013 (PHILADELPHIA INQUIRER)--The morning-after pill debate began anew this week when the U.S. Food and Drug Administration quietly said that Teva Pharmaceutical Industries Ltd. would have three years of exclusive rights to sell Plan B One-Step oral contraceptives to anyone of any age as an over-the-counter product.

Teva is based in Israel, but its Americas headquarters is in North Wales, Montgomery County.

For more than a decade, women's health groups have pushed the FDA and two presidential administrations to make such contraceptives available to women of all ages without a prescription. The contraceptive, with levonorgestrel the active ingredient, is designed to work within 72 hours of sexual intercourse.

On April 5, federal Judge Edward Korman in Brooklyn, N.Y., ordered the FDA to make levonorgestrel-based emergency contraceptives available without a prescription and without age or point-of-sale restrictions.

Korman said the FDA could decide which versions of the drug were safe for over-the-counter use.

The FDA granted exclusivity to Teva's Plan B One-Step (PBOS) because Teva revised the labeling and submitted study data showing that directions for taking its single-pill treatment were easier for adolescents to follow than a two-pill regimen.

Exclusivity is an incentive to manufacturers to research and produce new medicine. Teva's Plan B One-Step will be the only version available on store shelves to all women, which can give Teva an edge on competitors. A PBOS can cost $50, while some generic products have cost as little as $10 or $20.

Teva also made the original Plan B, which has two pills, but stopped making that product after generic competitors entered the market.

Two-pill generic versions will still be available without a prescription for women 17 and older, but at the pharmacy counter. Women younger than 17 will still need a prescription for the two-pill version.

Teva spokeswoman Denise Bradley declined comment.

Women's health groups were not happy with the FDA's granting exclusivity to Teva, because the likely higher price will impede low-income women from buying the medicine.

There is strong evidence that generic versions are safe for over-the-counter use by women of all ages, Jessica Arons, chief executive officer of Reproductive Health Technologies Project, said in a statement. Of the FDA move, Arons said, "Basically, it is yet one more missed opportunity for the administration to get it right on emergency contraception."

Contact David Sell at 215-854-4506 or dsell@phillynews.com, or follow on Twitter @phillypharma. Read his blog at www.inquirer.com/phillypharma.

NewsEdge
 

Posted: July 2013


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