Sebelius Says Teva Can Reapply to End Morning-After Pill Limits for Girls
Kathleen Sebelius, secretary of U.S. Health and Human Services, said her decision against removing age controls on Teva Pharmaceutical Industries Ltd. (TEVA)’s emergency contraceptive wasn’t political, and the company can reapply.
Teva can submit an application with more testing for label comprehension and use among the girls at younger reproductive ages, Sebelius said at a meeting on health-care jobs in New York. The comment came after Mayor Michael Bloomberg earlier today said he disagreed with Sebelius’s stand.
“There are always opportunities for the company to come back with additional data,” Sebelius told reporters after the meeting, held at LaGuardia Community College in Queens. “Subsequent discussions can take place.”
Sebelius overruled a recommendation by Food and Drug Administration Commissioner Margaret Hamburg on Dec. 7 to end the age restrictions on Teva’s Plan B One-Step contraceptive. It was the first time HHS reversed an agency approval.
“It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non- prescription availability of this product for all ages,” Sebelius wrote Hamburg in the Dec. 7 memo.
Hamburg had said she was ready to allow sales to girls younger than 17 based on “science-based evidence.”
Sebelius today said her decision wasn’t “about politics.”
President Barack Obama said he supported Sebelius’s decision the day after it occurred. Bloomberg, at today’s jobs meeting, split with the president, saying he agreed with the FDA chief.
“Why Sebelius decided to overrule her, I don’t know,” Bloomberg said at the jobs meeting. “We’ve had many, too many, unwed births in this country. It would be much better if these young girls didn’t get pregnant.”
Teva, based in Petach Tikva, Israel, said Dec. 7 it was “disappointed” with the HHS’s decision, and that it would determine its next steps after receiving official notification of the decision.
Denise Bradley, a spokeswoman for the company, declined to comment. The company’s American depositary receipts increased 1.1 percent to $40.66 at 4 p.m. in New York.
Teva’s product reduces pregnancy risk if taken within three days of sex. As a result of Sebelius’s order, the pill will continue to be kept behind pharmacy counters and sold without prescription only to women at least 17 years old. Younger girls may obtain the drug with a doctor’s order.
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