Teva gets three years of exclusivity for morning-after contraceptive Plan B One-Step

Teva's Plan B' One-Step, a one-pill emergency contraceptive, sometimes referred to as a morning-after pill is finally going over-the-counter. The Food and Drug Administration on Thursday, June 20, 2013, approved unrestricted sales of Plan B One-Step, lifting all age limits on the emergency contraceptive. (AP Photo/Barr Pharmaceuticals Inc., File)

The morning-after contraceptive pill debate began anew this week when the FDA late on Monday evening quietly said that Teva Pharmaceutical Industries, Ltd., would have three years of exclusive rights to sell Plan B One-Step oral contraceptives to anyone of any age as an over-the-counter product.

For more than a decade, women's health groups have pushed the FDA to make such contraceptives more available to women of all ages without a prescription. The contraceptive is designed to work within 72 hours of sexual intercourse.

Women's groups have argued that women should have choice about pregnancy and that unwanted pregnancies are costly and bad for society, the mothers and the children brought into the world under those terms. The concerns of the women's groups often involved barriers to acquiring the medicine, including having a prescription, the need to ask a pharmacist, limited hours of pharmacies even if the drug store is open, lack of identification and price.

Presidents Bush and Obama were less keen on the whole idea and the fight has been waged in U.S. Federal Court in Brooklyn for several years. Judge Edward Korman was very critical of the Health and Human Services Secretary Kathleen Sebelius when she overruled FDA officials, who said the drug was safe and effective, thereby keeping it restricted behind the pharmacy counter.

As much as they didn't like Korman's decisions and criticism, the White House, Sebelius and the FDA, which is part of HHS, did not want the case to move from Korman's court to the U.S. Court of Appeals for the Second Circuit. To try to meet Korman's orders, the FDA approved Teva's revised application with new labeling that removes the age restrictions from Plan B One-Step.

But Teva - as would any other company trying to profit from the sale of a product - hoped to get three years of market exclusivity, an allowance that is part of the U.S. pharmaceutical laws because it serves as an incentive to manufacturers to research and produce new medicine. However, that exclusivity will allow Teva to raise the price and reduce the competitors in that market. Because of the new labeling, Teva's Plan B One-Step will be the only one-pill version available on store shelves.

Teva's Plan B One-Step can run $50, while some generic products have cost as little as $10 or $20.

Teva also made the original two-pill Plan B, but no longer does because there was insufficient profit after generic competitors entered the market. Two-pill, generic versions have been on the market, albeit behind pharmacy counters and requiring a prescription for women under 17.

The FDA posted the first notice of its decision on its Orange Book web site, which is a spot for listings of drugs and their status. A link to the Orange Book listing is here. Levonorgestrel is the chemical name of the the active ingredient in Plan B One-Step. On second reference, the FDA and others refer to Plan B One-Step as PBOS.

FDA spokeswoman Stephanie Yao said via email, "This decision only applies to PBOS and affects its generics (one pill). Plan B and its generics (two pills) are not involved. The Court’s order said that the FDA could make only PBOS available OTC without age restriction if the agency believes there is a significant difference between Plan B (and Next Choice, a generic of Plan B) and PBOS. FDA has determined that PBOS and Plan B are different. The PBOS application contained actual use data specifically addressing the ability of adolescents, including younger adolescents, to understand and follow the directions for safe and effective use as a nonprescription product. There are fewer data on actual use of Plan B by younger adolescents without a prescription. Plan B and its generics (two pills) remain available OTC for women older than 17. Women 17 and younger will need a prescription."

Teva spokeswoman Denise Bradley declined comment.

Women's health groups were not happy with the FDA granting exclusivity to Teva.

“We are disappointed by FDA’s most recent decision to maintain age restrictions on generic brands of emergency contraception, which will leave more affordable alternatives of safe and simple emergency contraception products out of reach for many women," Jessica Arons, president and chief CEO of Reproductive Health Technologies Project, said in a statement. "This decision is not supported by the evidence presented to the Administration, will only lead to more confusion on the part of consumers and pharmacies, and will continue to unnecessarily feed the false assertions by some that emergency contraception is unsafe or risky.

“Basically, it is yet one more missed opportunity for the Administration to get it right on emergency contraception. In justifying this move, FDA continues to contradict the recommendations of its own experts by arguing that insufficient data exist to approve over-the-counter status for generic brands. Yet over a decade ago, FDA scientists determined that levonorgestrel-based emergency contraception was safe and effective for over-the-counter use by women of all ages and no further information was needed to make that determination. Thus, based on FDA’s own conclusions and recommendations, all products - including the one-pill generic versions of emergency contraception - should be made available to women and couples now without unnecessary restrictions.”