FDA roadblock awaits Des Plaines radiopharmacyRadiopharmacy chain Medi-Physics and cyclotron developer CTI Serviceshave entered a joint-venture agreement to operate a regional PETradiopharmacy to supply the Chicago area with
Radiopharmacy chain Medi-Physics and cyclotron developer CTI Serviceshave entered a joint-venture agreement to operate a regional PETradiopharmacy to supply the Chicago area with 18-fluorodeoxyglucose(FDG). The deal represents another step in the growing regionalcyclotron effort, which can make PET imaging more cost-effectiveby allowing PET centers to operate without a cyclotron on site.
Medi-Physics, of Arlington Heights, IL, has installed a CTIcyclotron at its radiopharmacy in Des Plaines, IL, a suburb ofChicago. Rather than buy the cyclotron outright, Medi-Physicshas secured the use of the system from CTI in exchange for revenuesharing from FDG sold by the radiopharmacy, according to WilliamEhmig, vice president for professional affairs for Medi-Physics.
The arrangement allows the companies to share both the rewardsand risks of PET imaging, which continues to be plagued by regulatoryand reimbursement questions. If the deal works well, Medi-Physicsmay pursue other regional cyclotron agreements with CTI, whichis based in Knoxville, TN.
Ehmig estimates that there are two or three PET scanners operatingin the Chicago area, with several more hospitals interested inpurchasing systems. The Des Plaines facility will also get a boostfrom growing interest in high-energy imaging using FDG SPECT.
"(High-energy imaging) is going to very significantlyraise the interest in having (FDG) available," Ehmig said."That may be the breakthrough."
The Des Plaines site may be on a collision course with theFood and Drug Administration, however. The radiopharmacy may runafoul of the FDA's requirement that facilities producing cyclotron-basedPET radiopharmaceuticals receive new drug applications (NDAs)for their formulations before their products can be used clinically.
Ehmig said Medi-Physics believes that the Des Plaines facilityis covered by state practice of pharmacy laws, and the companyhas received the appropriate licenses from the state of Illinoisto begin operation. Medi-Physics does not intend to file for anNDA.
"Our regulatory people don't agree with (the FDA's) interpretation,"Ehmig said.
Radiopharmacy competitor Syncor International has also takenissue with the FDA's ruling on PET radiopharmaceuticals. The companyfiled suit against the agency last month seeking to have the NDAregulations overturned (see story, page 1).