Morning-after pill, Sometime in the months ahead, women who want to buy the emergency birth-control pill known as Plan B One-Step are likely to be spared the embarrassing ritual of asking for it at the pharmacy counter. Anyone will be able to grab it off the shelf in the women’s health aisle.The change is a result of the decision on Monday by the Obama administration to end its objections to allowing adolescents to buy the pill without a prescription. The Justice Department said the Food and Drug Administration would make the pill available over the counter for all ages as a proposed solution to fulfilling a judge’s order.
But as significant as the decision was for advocates of women’s reproductive rights — and as touchy as the issue has been politically — it will most likely have little impact on the bottom line of Teva Pharmaceutical Industries, the company that makes the drug.
Plan B One-Step brought in over-the-counter sales of about $93 million from the middle of May in 2012 to the same period this year, according to IRI, a Chicago-based market research firm. That figure pales in comparison to the $4 billion in sales generated in 2012 by Teva’s top-selling drug, the multiple sclerosis treatment Copaxone. Indeed, the news barely budged Teva’s stock, which closed down 0.42 percent Tuesday, to $39.83.
Some industry analysts said the drug was simply not on their radar and was rarely discussed during earnings calls or in company presentations.
Still, the company said lifting the restrictions on the drug would amount to a significant victory for women of all ages who need it, not just those who are under 17. As Plan B One-Step is currently sold, girls under 17 need a prescription from the doctor.
But women of all ages must ask for the drug, as well as a generic version, Next Choice One Dose by the drug maker Actavis, at the pharmacy counter. The drug should be taken as soon after sexual intercourse as possible, but women sometimes have to wait until the next morning if the counter is closed when they arrive.
For that reason, “it’s not really about making it available to women under 17, it’s about making it available to all women,” said Denise Bradley, a spokeswoman for Teva.
Studies have shown that the number of women who have used emergency contraception is growing. Between 2006 and 2010, a survey from the Centers for Disease Control and Prevention showed that about 11 percent of sexually experienced women age 15 to 44 had used the pills, compared to 4.2 percent in 2002. Women age 20 to 24 were the most likely to have used the drug — about 23 percent had done so. By comparison, about 14 percent of sexually experienced women age 15 to 19 had used it.
In April, Teva received approval from the F.D.A. to begin selling Plan B One-Step over the counter to anyone who could show that they were 15 or older. Under the terms of that approval, the company could stock the product in the women’s health aisle of the drugstore, but it must be sold in tamper-proof, clamshell packaging — similar to the plastic packaging that encases razor blades or small electronics. Women also had to provide government-issued proof of their age. Ms. Bradley said the company would begin selling the product in drugstore aisles in about a month.
Now, it is likely that all age and sales restrictions will eventually be lifted, although neither the F.D.A. nor Teva would comment on when that would happen.
That development grew out of a battle that has lasted a dozen years. The most recent chapter began in December 2011, when Kathleen Sebelius, the secretary of health and human services, overruled a decision by the F.D.A. to lift all age restrictions on the drug and allow it to be sold over the counter.
In April, Judge Edward R. Korman of the United States District Court for the Eastern District of New York ordered the federal government to lift all age restrictions on the drug and to make it available without a prescription. The Justice Department’s proposal is still subject to Judge Korman’s approval. Still, plaintiffs who disagree with a provision of the plan that would maintain the previous restrictions for a two-dose version of the pill said on Tuesday they plan to challenge it. Although Teva and Actavis sell only a one-pill product, another company, Perrigo, sells an older version that requires taking two pills 12 hours apart.
If those hurdles are cleared, Teva will need to submit an application asking for the age and sales limits to be removed. Then, according to the Justice Department, the “F.D.A. will approve it without delay.”
0 comments:
Post a Comment