Teva Pharmaceutical Industries Ltd. (TEVA)’s emergency contraceptive may be the first approved for over-the- counter use by females of any age under a decision being considered by U.S. regulators.
In 2009, a federal court said restrictions on the drug, which reduces pregnancy risk if taken within three days of sex, were arbitrary, based more on political pressure than safety. Teva in February asked that the Food and Drug Administration review rules that the drug be kept behind pharmacy counters and sold without a prescription only to women older than age 17.
The FDA action has drawn mixed reviews. Supporters say a change will allow for quicker access when it’s most needed, and an industry analyst said it may be a catalyst for Teva’s fading stock. Foes say that allowing younger girls unrestricted access means they may not get 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.”
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 consider that 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.”
Sales of Plan B increased 120 percent when it became available without prescription for women 18 and older in 2006, Petach Tikva, Israel-based Teva said. If the FDA approves Plan B for over-the-counter use by all ages, competing products, including generic brands and Watson Pharmaceutical (WPI) 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 “We’ve been seeing a mostly negative story.” He said the decision could boost the company’s shares.
The company’s American depositary receipts gained less than 1 percent to $40.05 at the close in New York. Each receipt is equal to one ordinary share. The receipts have declined 23 percent this year.
Marion Glick, a Teva spokeswoman, didn’t immediately respond to requests for an interview on the FDA’s pending decision.
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