FDA Guidance - Generic Versions of combo Drug AND Device

“Scott Gottlieb, the commissioner of the Food and Drug Administration, this morning announced plans to speed generic versions of treatments that combine a drug and a device”

“While EpiPen isn’t mentioned, the guidance could make it easier for competitors to enter this category.”

Does this impact diabetes? Well only if you can think of anything that potentially combines a drug and a device.

CNBC: FDA issues guidance that could make it easier for EpiPen rivals to come to market

Forbes: FDA Boss Aims To Close EpiPen Loophole

Hmmmm…marijuana and the television remote?



This kind of announcement frustrates me. So they’re announcing that they’re going to behave like less of a hindrance to people getting the drugs they need at a price they can afford. Bravo, big round of applause for them. If they hadn’t completely screwed the system up thus far and been more of a tool for big pharma and special interests to manipulate than a legitimate and efficient regulatory body we wouldn’t be in the mess we’re in to begin with. I’m no fan of the FDA.

Isn’t an insulin pen and cartridge a combination drug and delivery device? Or for that matter, an insulin pump and insulin?
Why couldn’t this cause an explosion of pump manufacturers based on existing devices?

I know that of course we’re talking about the FDA, and not some rational government agency. Hey, that’s pretty funny, a “rational government agency”.

Absolutely. As I read the articles, it sounds like the FDA wanted to address the EpiPen issue without being specific. Which would certainly seems to cover insulin pens and afrezza. Insulin pumps I think would be a stretch given that you get the pumps from the one place and the insulin from another place - perhaps not exactly covered under the same guidance?
In any event, I think it will require some time to see what the actual impacts may be.