Despite New Legislation, Plan B Still Isn’t on the Shelves
Last week, the U.S. Food and Drug Administration (FDA) announced that Plan B, a morning-after pill, will now be available to all women over the age of 15. The drug will even be moved from behind the pharmacy counter and onto drugstore shelves next to the condoms and tampons, adding to ease of access. But if you head to any drug store, you won’t find Plan B on the shelves just yet. In fact, the $50 Plan B One-Step product, which is a hormone pill that prevents pregnancy if taken within three days of unprotected sex, is still behind the pharmacy counter today, accompanied by two generic versions of the same medication. Pharmacists can still only dispense the pills to customers who are 17 or older.
So, FDA, what gives?
According to The Globe:
Teva Pharmaceuticals, manufacturer of Plan B, must ship the one pill products with new packaging and labels before pharmacies can put the product out in the open on shelves, according to the FDA.
“We have not yet had [newly packaged] product shipped to stores and don’t anticipate they will be for another month or so,” Teva vice president Denise Bradley told me via email.
In order to completely lift the age restrictions on the product, the company must resubmit an old application to the FDA that shows the product is safe for girls of all ages to take. The FDA rejected that application before and encouraged Teva to ask for an age lowering to 15 instead.
Bradley said Teva is also working “with due speed to resubmit our application as soon as possible.”
To complicate things even further, Teva has been granted exclusivity rights by the FDA for the next three years. Yep, that’s right — they better get their act together and get that application in, because for the next three years, they’ll be the only ones allowed to sell Plan B without restrictions to women over the age of 15. Boston.com also reported that cheap, two-pill generic versions of Plan B will likely never make it onto the shelves without restrictions, at least not in the foreseeable future. The FDA requires another application for two-pill versions of the drug, and no generic pill manufacturer has stepped up so far.
What does this all mean? Basically, after millions of dollars and decades of lawsuits, it seems like the FDA is taking it’s sweet time about making emergency contraception readily available. Plus, reproductive activists may not have gained all that much ground in providing emergency contraception for younger women and low income women. Although the one pill version of the drug will hopefully appear on the shelves sometime in the near future (fingers crossed), the only option available will likely be the most expensive option— the $50, non-generic option— as Teva has a complete monopoly on the market.
And although US District Court Judge Edward Korman has been vocal about reversing the monopoly that Teva has on the market right now, it looks like the emergency contraception drama will continue. Here’s to hoping that we’ll see at least one version of the drug on the shelves in the next few weeks.