Teva Pharmaceutical Industries Ltd. failed to win U.S. clearance for the first over-the-counter emergency contraceptive after an Obama Cabinet member overruled the head of the Food and Drug Administration on the issue.
Secretary of Health and Human Services Kathleen Sebelius ordered Margaret Hamburg, the FDA chief, to reject the application by Petach Tikva, Israel-based Teva, citing potential sales to girls under age 17. Hamburg, in a statement, said she was ready to approve over-the-counter sales based on “well-supported” and “science-based evidence.” The FDA said it’s the first time the HHS has reversed one of its decisions.
The product, called Plan B One-Step, reduces pregnancy risk if taken within three days of sex. As a result of Sebelius’s order, it will continue to be kept behind pharmacy counters and sold without prescription only to women 17 and older. Younger girls may obtain the drug with a doctor’s order.
“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 a memo today.
Representative Michael Burgess, a Texas Republican who opposed approval of Plan B for over-the-counter use in women under 17, said he was pleased by the decision, and called it a political one by Democrats.
“It’s a presidential election year,” Burgess said in a telephone interview. “This is a striking departure from where congressional Democrats and the administration has been in the past. I think it’s the correct answer; it just wasn’t what I expected today.”
Erin Shields, a spokeswoman for HHS, declined to comment on whether the White House had a role in Sebelius’s ruling. Erica Jefferson, an FDA spokeswoman, confirmed in an e-mail that it was the first time the health department overruled the agency.
“Somebody should sue because this involvement is clearly not a scientific decision,” said Aaron Gal, a Sanford Bernstein analyst in New York with a “market perform” rating on Teva. “The administration is taking a paternalistic approach.”
Gal estimated Plan B sales at $60 million annually. Teva doesn’t specify revenue from the contraceptive, instead reporting 2010 sales of $374 million for all its women’s health products. Sales more than doubled when it became available without prescription for women 18 and older in 2006, the company has said.
The decision follows by two years a federal court ruling that age restrictions on the pill were arbitrary, based more on political pressure than safety. On Dec. 13, the FDA is scheduled to discuss its rulings involving emergency contraceptive products in the Eastern District of New York federal court. The civil case started with a 2001 petition by the New York-based Center for Reproductive Rights.
“Now there is a renewed opening for the court to evaluate whether what the FDA did was right,” said Amy Allina, a program director at the National Women’s Health Network in Washington, in an interview. “Right now we’re trying to make sure everybody gets the word that the FDA scientists disagreed with this decision.”
Teenage Pregnancy Costs
Teenage pregnancy and childbearing cost U.S. taxpayers an estimated $10.9 billion in 2008, according to report released in June by the National Campaign to Prevent Teen and Unplanned Pregnancy, a nonprofit advocacy group based in Washington and chaired by former New Jersey Republican Governor Thomas Kean. The report’s estimate includes the cost of U.S. and state health and welfare programs, incarceration and lost tax revenue from decreased spending and earnings, the group said in a statement.
Teva said in a statement it will determine its next steps when it receives official notification of the decision.
“We commend the FDA for making the recommendation to approve providing women with increased over-the-counter access,” the company said in the statement. “We are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion.”
Plan B One-Step is made with levongestrel, an ingredient found in birth control pills, and is linked with side effects that can include nausea, dizziness, changes in menstrual periods and fatigue. Competing products include generic brands and Watson Pharmaceutical Inc.’s Ella.
Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists, based in Holland, Michigan, said easing the rule would have denied teenagers access to proper counseling or testing for sexually transmitted diseases.
In 2009, when the FDA lowered the age for over-the-counter use to 17 from 18, Republican senators wrote the agency asking for data underlying the decision. The letter also suggested that access to the drug at a young age could end up covering up sexual abuse.
“This is not a health product,” Harrison said.
Nancy Stanwood, a gynecologist at the Yale School of Medicine in New Haven, Connecticut, said the ruling was “really unfortunate.
‘‘Younger women need emergency access because younger women aren’t as effective at Plan A,’’ Stanwood said in a telephone interview. ‘‘They might have a condom accident or forget to use one.’’
The case is Tummino v. Torti, 05-CV-366, U.S. District Court, Eastern District of New York (Brooklyn).