Teva Pharmaceutical Industries Ltd.’s emergency contraceptive may be the first approved for over-the-counter use by females of all ages if U.S. regulators today lift restrictions.
Teva in February asked the Food and Drug Administration to review rules that require the product, called Plan B One-Step, be kept behind pharmacy counters and sold with a prescription to girls younger than 17 years old. The so-called morning-after pill reduces pregnancy risk if taken within three days of sex.
Supporters say putting the product on stores shelves, and providing access without a doctor’s prescription to those younger than 17, will allow women to get the pill when it’s most needed. Foes say easing the rules may mean younger teenagers may not receive needed counseling or testing for sexually transmitted diseases.
“This means that all women will have timely access to this safe backup method of contraception if they need it,” said Amy Allina, a program director at the National Women’s Health Network in Washington. “We are extremely optimistic.”
If Teva gets approval, the company will start a marketing campaign focused on the drug’s availability, said Amy Niemann, vice president of Teva’s women’s health division. The ads will tell people Plan B One-Step is not an abortion pill and is only for use in emergencies, if a condom breaks, for example.
‘Not a Health Product’
Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists, based in Holland, Michigan, said that along with concerns about testing and counseling, U.S. officials should weigh whether predatory males may force minors to use the product.
“This is not a health product,” Harrison said. “We are isolating the women who need to see doctors most.”
Plan B One-Step is made with levongestrel, an ingredient found in birth control pills. Side effects can include nausea, dizziness, changes in menstrual periods and fatigue.
Sales of Plan B more than doubled when it became available without prescription for women 18 and older in 2006, Petach Tikva, Israel-based Teva said. If the FDA approves over-the-counter use by all ages, competing products, including generic brands and Watson Pharmaceutical Inc.’s Ella, will remain behind the pharmacy counter.
Teva investors have been “starved for good news recently,” said Judson Clark, an analyst with Edward Jones & Co. in Des Peres, Missouri. An FDA decision in favor of wider over-the-counter access may boost Teva’s shares, he said.
The company’s American depositary receipts were little changed at $40.02 at 10:51 a.m. in New York. Each receipt is equal to one ordinary share. The receipts have declined 23 percent this year before today.