The Food and Drug Administration said it has approved Teva's Plan B One-Step for all ages without a prescription, which represents another step in the decade long legal and regulatory debate over access to emergency oral contraception, often referred to as the morning-after pill.
New York Federal Judge Edward Korman - and briefly, so far, the U.S. Court of Appeals for the Second Circuit - has been officiating the legal arguments between the federal government and groups seeking greater access to the medicine for women of all ages and at the lowest possible price.
Teva Pharmaceutical Industries, Ltd., is based in Israel but has its Americas headquarters in Montgomery County, outside Philadelphia, makes Plan B One-Step.
Plan B One-Step is the one-pill version of the medicine, the active ingredient in which is levonorgestrel. Once the new labels are pasted to the packages and sent to stores, the product will be available on shelves....probably.
“Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
However, this does not end the fight.
The FDA statement did not indicate whether Teva will get three years of exclusivity for Plan B-One Step. If it did, Teva would have a monopoly and could charge a higher price.
There are two-pill versions made by several companies, but those still require a prescription for women under the age of 17. Since a prescription and proof of age is required, women would have to go to pharmacy counter, which also means the pharmacy has to be open. Many pharmacies within stores close before the rest of the store.
Women's health groups are fighting against the possibility of the exclusivity and fighting for greater access to the two-pill generic versions.
Teva has declined comment when asked if it would bother to sell Plan B One-Step without exclusivity.
An earlier PhillyPharma post on that is here.