Letter to nowhere

In June, after learning that the commissioner of the FDA has the authority to exempt a medication from prescription-dispensing requirements, I wrote a letter to the FDA asking for injectable B12 to be made available without a prescription. Last week I got a (mildly disappointing) response that reads in part:

"We appreciate your comments. Please be aware that it is the responsibility of drug sponsor/manufacturer to seek marketing approval of their prescription drug for OTC use. The FDA can not initiate a prescription drug's switch to OTC status nor does it have the regulatory authority to require manufacturers to pursue marketing of such a switch. It is up to the sponsor to provide the necessary data and information to FDA through the new drug application (NDA) process demonstrating the appropriateness of the drug for OTC marketing for the indication(s) sought, the effectiveness of the drug with OTC use, and that the drug has a sufficient safety profile for OTC marketing (i.e., it can be safely used without a learned intermediary). You may wish to contact the sponsors/manufacturers of injectable cyanocobalamin to see if any have plans to pursue OTC marketing of their product."

So now I just need to know who to contact in manufacturing and how to convince them that it is worthwhile to pursue switching it to over the counter.

While I'm daydreaming about the success of that endeavor I can't help thinking that the product that would be really great to introduce for OTC would be one of those dial-up-a-dose injector pens like they have for insulin.

2 Replies

  • Hi Galixie,

    Its a nice dream, and I must agree that I do not understand why in other countries B12 ampoules are available OTC and not in some, who is responsible for that divide is not obvious to me. Believe in UK its because it involves an injection that it is regulated, not so much the B12.


  • Just stress to the Manufactures how much their sales will increase if a prescription is not required.

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