FDA's New Guidelines for PET Drugs Could Be Burden for Small Producers

by Brendon Nafziger, DOTmed News Associate Editor | December 17, 2009

"They had to research it quite carefully," says Dr. Graham, "and the documents released now indicate the care which they've taken."

Part of the difficulty in figuring out the rules is that the manufacturing of PET drugs presents a challenge not present when making normal pharmaceuticals.

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"There are some practical issues," says Dr. Graham. "You can't do it like making the usual drugs like aspirin or ibuprofen, because of the short half-life of [radiopharmaceuticals]." For instance, a common PET drug, fluorodeoxyglucose (18F), has a half-life of only 109 minutes. "You can't do careful sterility testing that may take hours or days, so there have to be obvious compromises in terms of how they're manufactured."

"This is not a simple topic for the FDA to make decisions on," he adds. "Radiopharmaceutical manufacturing has to be different."

For more information on the FDA's ruling, visit the page they've set up: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm

For more information on SNM's upcoming meet-the-FDA workshop or to register, visit their Clinical Trials Network site: http://interactive.snm.org/index.cfm?PageID=8813&RPID=1977

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