Very cool
Thirteen year old girl invents lollipop that cures hiccups: Hiccupops. I wonder if these will be given the OK by the .gov or if another kids is about to get an education in bureaucracy.
Remember, I do this to entertain me, not you.
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May 10th, 2012 at 10:45 am
My guess: Regulatory fines for moving to human testing before getting FDA approval.
May 10th, 2012 at 10:50 am
It will get approved, then 50% of everything she makes will go to the .gov. Then her manufacturing will get expensive because of big labor and the EPA. She’ll relocated the mfg operation to China, where they will promptly steal her work and sell a knock off product for half as much. By 18 she’ll be broken and drinking herself silly every night.
May 10th, 2012 at 11:17 am
She’s screwed. The lolipop is used to treat a medical condition so it’s at least a Class II medical device.
She’ll need to show Failure Mode and Effect Analysis, risk assesment and management documentaion, quality management systems and to become a certified medical device manufacturer.
She will need to show design history and document all clinical studies. She’s already screwed the pooch because she has not gone to FDA with a pre market submission for them to review. The time frame for a complete review if all the paperwork is 6 to 12 months.
If they consider this a drug, I’m not sure she could ever get it done then less than 3 years.
I’m in the middle of this stuff at work and it’s more headache than I had dealing with chemical weapons and explosives.
May 10th, 2012 at 11:18 am
The FDA will likely get involved. She is making claims that her product treats a medical condition without the appropriate FDA approval.
May 10th, 2012 at 12:10 pm
She’ll be lucky if she doesn’t get raided by an FDA SWAT (shooting her dog will be free and per SOP) AND slapped with a federal felony.
May 10th, 2012 at 6:22 pm
I hope she has the patent number already, because someone with all the bona fides already will steal it, but the patent will probably expire before she can turn a profit anyway, so she has that going for her. Or something.
May 10th, 2012 at 8:10 pm
Meth heads will find a use for these and the DEA will make collateral damage out of her idea.
May 10th, 2012 at 9:15 pm
Bunch of paranoid whiners. Whenever somebody breaks a law and gets caught, they always put a spin on the story about how everything is somebody else’s fault.
The government can be an ass. The government is a convenient scape goat.
When an inventor stakes his family fortune on developing a better seatbelt, and DOT tests it and says “We can tell you put a lot of work into this, but it’ll snap the spine of everyone who weighs more than 105 pounds”, does the inventor meekly go back to work? No! He lies and tries to drum up more venture capital by mischaracterizing his product and what the government said.
When FDA impounds a dozen tons of imported wagu beef for being full of tapeworms, does the importer admit to fertilizing the cows’ food soy with raw human waste? Of course not! The importer claims he was set up and runs to bribe a few reporters to put a positive spin on the story.
When you already know the details of the story, you know the press is always lying and spinning. Why assume that the press is being completely honest when you don’t know the details?
May 12th, 2012 at 6:11 pm
@dustydog:
You didnt read the story, did you?