Generic EC: Sleeper Story of the Summer


Hat tip to EmpowHer: the FDA approved over-the counter use of a generic version of Plan B, called Next Choice, over the summer.

The FDA first approved Next Choice for prescription use in June, and in August, the drug’s manufacturer, Watson Pharmaceuticals, announced that it would be available over the counter. (You can read Next Choice’s drug facts here.)

News to me. I couldn’t find anything on Next Choice in the New York Times, the LA Times, the Washington Post, or the Boston Globe. Perhaps the media is experiencing EC fatigue after this spring’s ruckus (only the latest skirmish in a years-long fight)—or contraception advocates are keeping quiet so as not to attract the attention of the crazies.

But generic EC is an important development, as Nancy Ratzan, President of the National Council of Jewish Women reminds us (via the Feminist Majority Foundation):

"Despite recent efforts to increase access to emergency contraception, cost is still a barrier for many women…all women, regardless of age, income, religion, race or geographic location should have access to the full range of contraceptive options. The introduction of a generic for Plan B is an important step toward achieving that important goal."

EC is a vital component of reproductive health, the more pharma companies that get in on the act, the better. Our mothers probably never imagined the cornucopia of hormonal contraceptives we’d have to choose from—not only pills (over a hundred brands), but also patches and rings. Granted, the formula for EC is probably less variable than that of the daily pill. But competition is good for our health and our wallets. Next Choice is going to cost about 10 percent less than Plan B, which is a good start. And however contentious the EC debate remains, emergency contraception itself must not be ignored.

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  • crowepps

    From my somewhat cursory look on the web, a month’s supply of regular birth control pills is a maximum of $50 and a one-time use supply of Plan B is about $50. Is there any connection at ALL between what medication costs to produce and the price that is charged the customer? Considering that trying to get them promptly AFTER the need arises is being made as difficult as possible, everybody ought to have a pack of Plan B in the medicine chest for emergencies, but considering that they expire, at $50 or even $45 that’s not going to happen.

  • sschoice

    "Generic ec" is an interesting term.  If one means the prepackaged formulation called Next Choice, it may not have made much of a media splash because it really wasn’t a significant event. Antis were surely aware of it but weren’t making a big deal because while it’s a little bit of good news for prochoice folk it really isn’t much more than what we had before.

     

    If it’s being sold for about 10% less than Plan B of whatever formulation: One-Step, the older two-step formulation no longer distributed by Duramed, or the soon-to-be-released formulations Tango and Mosh Pit, Next Choice would only be a few dollars per prepackaged dose cheaper than Plan B, not really worth driving out of one’s way for (or adding an extra bus or train transfer), and maybe not even reasonably expecting some pharmacies to stock besides the much better known (and prescribed and asked for) Plan B.  Some pharmacies have had issues with Plan B sitting on the shelf and expiring (the shelf life cited for the one-step formulation changed to 36 months, though some online sources vary in that figure) and unfortunately it’s likely that a rural or suburban pharmacy that never sold much Plan B would sell even less Next Choice. 

     

    One might still say that a pharmacy has a moral obligation to stock Next Choice, maybe even in addition to Plan B One-Step, but it’s obvious too that if very little or none is sold they won’t likely have much motivation to do so. That was probably a bigger issue anyway than so-called "conscience" in pharmacies not stocking Plan B or the now-discontinued formulation PREVEN, as "conscience" rarely seems to get in the way of pharmacies stocking some varieties of bcps (birth control pills) which were known to sell well, and it’s really only obvious economic reasons why other pills which don’t sell well aren’t as likely to be stocked.

     

    Also, at 10 percent less than Plan B, Next Choice is still much more expensive than truly generic EC could be, which would be levonorgestrel birth control pills taken in sufficient dose to equal the one- or two-step EC doses which Plan B was able to successfully package and market.

     

    One would have to get a prescription for levo-only pills, like one would any other bcps to obtain them from a US pharmacy, and it would be "off label" (which mainly means that the doctor prescribing it really needs to know what they’re doing and engage the patient in fully informed consent if they decide to use said drug "off label" — which would be a good standard to set anyway even for prescribing something "on label"). 

     

    However, filling a prescription in the US for levo-only pills would seem to be a problem.  We’ve looked into this, and we haven’t found a US drug manufacturer who makes a progestin-only birth control pill for sale in the US with just levonorgesterel, so filling a prescription in the US for something that would be the chemical equivalent of Plan B may be impossible. It doesn’t appear that a levo-only formulation couldn’t be sold in the US, but if it is (or ever has been) we don’t know of it. 

     

    Levo-only pills are sold in other countries (like Norgeston in the UK) but not in a sufficient dose to be as practical as Plan B and related formulations to take for ec.  Norgeston has 30 micrograms levo, which would require 50 pills taken in two doses of 25 pills each to approximate the 750 micrograms x 2 dose of Plan B or Next Step, or 50 pills at once for the 1500 microgram dose of Plan B One-Step.  Obviously the 25 pills x 2 dose would be easier to take, and numerous guides online have said that would be effective to take for ec.

     

    If levo-only pills, especially in a very inexpensive generic form, were at least available in the US, that would be good to know, and maybe going out of one’s way for (or mail-ordering, with a prescription).  Two month’s supply of Norgeston or the generic equivalent might cost much less than Plan B, especially as — obtained by prescription — it could easily be covered by insurance which covers prescription drugs, including birth control pills.

     

    –southern students for choice, athens

  • sschoice

    The shelf life of Next Choice and Plan B One-Step are both 24 months, so if one bought a dose at $50 that’s $25/year for the protection it would offer. That shelf life and cost per year would probably not be much of a problem for users assuming they could afford to buy it at cost in the first place, and besides that the personal issues involved in learning about it and buying it in the first place may be a bigger barrier than cost and shelf life.

     

    It would be interesting to know if freezing it would likely extend the shelf life.  As Plan B has been sold with shelf lives at least as long as 36 months it would seem that concern about the storage environment (and possibly a desire to sell more product) might be the reason for the relatively short shelf lives of these new products. 

     

    Although we wouldn’t recommend one keeping Next Choice or Plan B One-Step beyond it’s shelf life, it would be good to know if storing it in the freezer would be a good idea even for use within the designated timeframe.

  • dindin

    Hi Kathleen: All due respect to EmpowerHer, over at the LiveJournal Birth Control community, where we have over 6,000 members, we’ve been on top changes to EC since May. The order to lower the OTC age The FDA Approval of Next Choice Information on Plan B One Step and The ABCs of EC. I do hope you’ll take a moment to stop by our community. We work very hard to get good information out to young men and women, and we’re proud of the work we do.

    http://community.livejournal.com/birthcontrol

    http://twitter.com/birth_control_