The FDA Curtain
How to keep your medical invention out of the rejected-product gulag
All inventors know it takes a lot of hard work to get ideas to
market. But have you ever thought about what it takes when your
product also requires FDA approval? Despite what you may think, getting FDA approval isn't
limited to huge corporations—entrepreneurs new to the game
can get it, too. Case in point: Chris Lipper, founder of
idea-development firm Chris Co. Inc. Back in 1995, Lipper launched
his Morristown, New Jersey, business selling temporary tattoos and
temporary tattoo hang tags for branded and licensed apparel
products. At the time, he was also trying to quit smoking. When he
noticed his daughter was reluctant to take her medicine, he thought
of adapting the technology at work in nicotine patches to temporary
tattoos. "[I thought,] 'Why not use temporary tattoos to
dispense medicine, especially to children?'" says Lipper,
37. He hoped one day to design temporary tattoos for kids who
needed medications such as Insulin and Ritalin. "I wanted to
have the tattoo change colors as the medicine left it, so
children's parents would know when the medication ran
out." A great idea, sure, but dispensing drugs through temporary
tattoos calls for FDA approval. Unwilling to give up, Lipper is
going through the process and hopes to receive the FDA's
blessing for his vitamin-dispensing Medicated Tattoos, or, as he
likes to call them, "Med-Tats," sometime in 2001 or early
2002, about two or three years since starting the process. In order
to get approval for dispensing over-the-counter and prescription
drugs, though, he expects to wait another three to four years. Content Continues Below
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