NDA requirement could stymie PET

Syncor International has filed a petition with the Food and DrugAdministration in a move related to the agency's review of radiopharmaceuticalsfor positron emission computed tomography.

Syncor, headquartered in Chatsworth, CA, operates 94 nuclear pharmaciesin the U.S. The petition comes on the heels of the FDA's favorablereview of 18-fluorodeoxyglucose (FDG-18), an isotope frequentlyused in PET exams.

The FDA reviewed a drug master file for FDG-18 submitted by theInstitute for Clinical PET (ICP). On May 22, an FDA advisory panelfound FDG-18 safe and effective for evaluating suspected epilepsy,establishing myocardial viability and localizing brain tumors.

The Health Care Financing Administration has said it cannot ruleon reimbursement for PET until there is an FDA-approved product.Although rubidium-82, used in PET cardiac applications, was approvedlast year, the agency has remained mute on the reimbursement issue.

PET proponents hope that FDA approval of FDG-18 will nudge HCFAinto action. But to complete its paperwork, the FDA is also askingthe ICP to file a new drug application (NDA) for FDG-18.

Both Syncor and the Society of Nuclear Medicine have raised objectionsabout requiring NDAs for radiopharmaceuticals. State laws alreadyexist governing the practice of nuclear pharmacy, according toJoan Herbst, business development specialist at Syncor.

If the FDA decides it must begin regulating the agents, individualdrug applications will need to be filed by all medical centersthat will use them. Critics say hospitals lack the financial resourcesto go through the conventional NDA process.

Syncor is concerned that access to PET will be restricted if centersmust qualify as drug manufacturers, Herbst said.

Instead of regulating end users, the Syncor petition suggeststhat the FDA regulate the equipment used to generate the compounds,she said.

"If the FDA requires end users to go through the IND (investigationalnew drug)/NDA process for FDG-18, it is going to cause problemsfor a lot of centers," she said. "And FDG-18 is justthe first drug. There are a multitude of others for which thispractice will have to be repeated over and over again."

Nothing has been heard from the FDA since the petition was filedMay 4, Herbst said.

"Legally, they don't have to respond to it," she said."They could just throw it away."

A vocal petition against instituting NDAs was also presented tothe FDA by Dr. Naomi P. Alazraki, co-director of nuclear medicineat Emory University, Atlanta. Alazraki testified at the FDA hearingon FDG-18 in May.

"Radiopharmaceuticals should be treated the same as nonradioactivedrugs," she said. "As long as FDG is not produced andused intrastate, its use should be governed solely by state laws."

In an interview last year, Alazraki said establishing NDAs forPET radiopharmaceuticals benefits commercial suppliers but physiciansshould not need NDAs in order to use the agents.