Search for Norm Young, Healthy Males Help Firm Test Generic Drugs for FDA Approval

By Buddenhagen, Brian | St Louis Post-Dispatch (MO), February 19, 1997 | Go to article overview
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Search for Norm Young, Healthy Males Help Firm Test Generic Drugs for FDA Approval


Buddenhagen, Brian, St Louis Post-Dispatch (MO)


Gateway Medical Research Inc. is looking for a few good men: 25 to 35, healthy and non-smoking.

The company at 116 North Main Street in St. Charles is involved in clinical research under contracts with pharmaceutical companies to test drugs for approval from the Food and Drug Administration.

Before founding Gateway Medical Research Inc., President Dan Shipley worked with KV Pharmaceuticals in St. Louis, Mallinkrodt Medical Inc. of St. Louis and the FDA. "You don't have to re-invent the wheel," he said. "All these generic companies need to do is prove that (the drugs) produce the same blood levels. That's called bio-equivalence." Gateway specializes in testing generic drugs, low-cost versions of brand-name drugs already on the shelves. It was founded in 1982 after congressional legislation intended to promote competition in the drug market. Congress passed two bills that made it easier to gain FDA approval for a generic drug. Instead of starting from scratch and going through years of expensive research and testing, a company can obtain approval for a competing generic drug by demonstrating that it is chemically equivalent to the original brand-name drug; the process typically takes six months. How does Gateway determine whether a drug is bio-equivalent? That's where the young male volunteers come in. "The hard part of the business is not the science," Shipley said. "The hard part is dealing with young, male, healthy volunteers. We go through a recruiting process to try to recruit normal people." Candidates go through a rigorous review process in which they are interviewed and have laboratory studies, physicals and electrocardiograms. The volunteers are asked to sign an informed-consent form that describes the study in which they will take part. From there the informed-consent forms are reviewed by the Institutional Review Board, an independent committee of five. "The Institutional Review Board reviews the informed consents and the protocol together to make sure everything called for in the study protocol is explained in the informed consent," said Shipley. "And, not only is it explained, but that it's in a simple, easy-to-understand language." Studies involving female volunteers are rare, Shipley says, because women run the risk of being pregnant without knowing it, and the experiments could put a fetus at risk. "The biggest difficulty is being normal, healthy and responsible," Shipley said. "We do drug screens on everybody. We basically want your apple-pie-and-mom kind of guy. Somebody who's a nice person, who's truthful about their medical history and lifestyle. "Our prime candidate would be 25 to 35, married and have two to five small children who need shoes. When you get a guy like that in the study, he's serious. They have a very responsible attitude.

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