The Fda Curtain

Entrepreneur, May, 2001 by Don Debelak

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.

FIRST STEPS

Lipper started by ironing out what he wanted his product to be: a tattoo with medication that would enter the skin on a time-release basis, over anywhere from eight hours to one week. He wanted the tattoo to have color-changing ability as well. Then he was off to meet with his patent attorney to see if any prior patents for similar ideas existed. The search didn't turn up anything, so Lipper was ready to start developing his idea.

He ran into several problems, though. First, he didn't know a chemist who could create a prototype. Second, he didn't know anyone who was familiar with submitting ideas to the FDA. And finally, most chemists and FDA consultants in the market prefer working with large companies that can offer big checks for services.

Lipper turned to his patent attorney for help, and his attorney referred him to consultants who recommended a recently retired chemist who was well-connected to the FDA. After meeting with Lipper, the chemist agreed to work on the project because he believed it was a great idea

Unfortunately, inventors often don't realize what a valuable resource the right patent attorney can be-especially patent attorneys who specialize in a particular market. They have other clients and can frequently steer you to useful contacts. You can find a patent attorney by asking other entrepreneurs in the same field who their patent attorneys are, by checking for similar patents on the PTO Web site (www.uspto.gov) and finding out what attorneys handle them, and by checking with the American Intellectual Property Law Association (AIPLA) for attorneys who handle products similar to yours. Visit AIPLA's Web site (www.aipla. org) for details.

GETTING APPROVED

Lipper and the chemist worked for about a year to finalize the time-release mechanism and drugs that could be dispensed through temporary tattoos. Lipper completed his application for a patent in 1999, giving him official patent-pending status. Then he was off to the FDA for a pre-IND (investigational new drug application) meeting to put together a plan for acquiring FDA approval.

According to Lipper, the FDA has been nothing but helpful from the start. "Of course, they want to be sure you do everything necessary to make sure your product is safe," he explains. "But the people at the FDA want to help, and they give you lots of advice and assistance?." What's the most valuable thing he's learned? It's best to make it clear to the FDA that you're a novice and ask questions like, "What should I do next?"

After the initial meeting, Lipper decided to pursue FDA approval for vitamin tattoos with an up-to-7-day time-release mechanism. (The clinical trial process for this kind of product is shorter, due to the fact that it requires fewer skin irritation tests.) Lipper plans to introduce his vitamin tattoo products late this year. Once those are introduced, he plans on starting clinical trials for over-the-counter medications for children. After that, his next goal will be approval for specialty drugs, such as morphine or methadone; that will also probably take three to four years. So while the FDA process certainly isn't easy or inexpensive, it's not so difficult that it can't be negotiated by even a novice in the industry.

STEP BY STEP

Every invention has unknowns that should be looked at before you start spending big money, and medical products face the added challenge of winning FDA approval. Sure, Lipper worried about the FDA, but he also worried about every other unknown confronting inventors. Here are some areas to investigate in the early stages: