President Barack Obama today backed his health secretary’s decision to overrule U.S. drug regulators and deny Teva Pharmaceutical Industries Ltd.’s request to sell its emergency contraceptive pill Plan B over the counter.
Secretary of Health and Human Services Kathleen Sebelius ordered Margaret Hamburg, the Food and Drug Administration chief, to reject the application by Petach Tikva, Israel-based Teva, citing potential sales to girls younger than age 17. Hamburg said she was ready yesterday to approve sales of Plan B One-Step without a prescription to women of all ages based on “science-based evidence.” The FDA said it was the first time HHS has overruled an agency approval.
“When it comes to 12-year-olds or 13-year-olds, the question is: Can we have confidence that they would potentially use Plan B properly?” Obama said at a press conference, adding that he wasn’t involved in the process.
Obama said that, as the father of two young daughters, he supports Sebelius’s decision.
“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 yesterday.
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 17 and older. Younger girls may obtain the drug with a doctor’s order.
Teva doesn’t specify sales from the contraceptive, instead reporting 2010 revenue of $374 million for all its women’s health products. Aaron Gal, a Sanford Bernstein analyst in New York, estimated Plan B generates $60 million a year. Sales more than doubled when it became available without prescription for women 18 and older in 2006, the company has said.
Teva said in a statement it will determine its next steps when it receives official notification of the decision. The stock fell less than 1 percent to 150.20 shekels in Tel Aviv.
Nancy Northup, president of the Center for Reproductive Rights, compared the Obama administration to that of former President George W. Bush, saying both are guilty of “playing politics with women’s health.”
“It is unacceptable that the approval for drugs supporting women’s reproductive health is held to a completely different standard,” she said in a statement.
Susan Wood, who resigned as the FDA’s women’s health director in 2005 because of the delay in approving over-the-counter emergency contraception, said she was shocked and disturbed by the administration’s move.
“This question of blocking the whole thing, blocking even this one product from going over the counter, is just too reminiscent of what happened before,” she said in a telephone interview. Wood called on Obama to order Sebelius to let the FDA do its job.
“I was there when he signed a memo on scientific integrity,” she said. “The people who have adequate expertise as to whether there is sufficient data about this are the scientists at the FDA.”
Wood was referring to a memo Obama wrote in March 2009, two months after taking office. “Political officials should not suppress or alter scientific or technological findings and conclusions,” he wrote. “The public must be able to trust the science and scientific process informing public policy decisions.”
White House Role
“This is a very highly effective commissioner,” David Kessler, head of the FDA from 1990 to 1997, said in a telephone interview. “We’ll all be served by her staying. But these moments are no fun.”
Scott Gottlieb, former deputy commissioner for medical and scientific affairs at FDA from 2005-2007, said he’d be surprised if Hamburg stepped down over the difference with Sebelius.
“This is the secretary’s prerogative and, while unprecedented in many respects, it’s well within the boundaries of her authority,” Gottlieb, now a fellow with the Washington-based American Enterprise Institute, said in an e-mail. Erica Jefferson, a spokeswoman for the FDA, said it’s the first time the HHS has reversed an approval.
Representative Michael Burgess, a Texas Republican who opposed approval of Plan B for over-the-counter use in teenagers younger than 17, said he was pleased by the decision, though he 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.”
Hamburg, in a statement, said she was told of the decision by Sebelius in the memo yesterday and was directed to reject Teva’s request to expand Plan B’s over-the-counter availability to females of all ages.
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.
Teenage Pregnancy Costs
U.S. girls ages 15 to 19 gave birth to 39.1 babies per 1,000 females in 2009, an 8 percent decline from the previous year and the lowest rate ever, according to the Atlanta-based Centers for Disease Control and Prevention.
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 health and welfare programs, incarceration and lost tax revenue from decreased spending and earnings, the group said in a statement.
Plan B 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. Teva’s product competes with generic brands and Watson Pharmaceutical Inc.’s Ella.
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).