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.

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This article was originally published in the May 2001 print edition of Entrepreneur with the headline: The FDA Curtain.

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