FDA releases new PET drug approval strategy

The Food and Drug Administration released a long-awaited guidance for PET drug applications March 7, and announced that it found three PET imaging isotopes safe for a variety of uses.

The notices followed negotiation with PET users and advocates over how to regulate the safety and efficacy of PET drugs, spurred by the 1997 FDA Modernization Act. The legislation required the agency to develop a unique approval process for the drugs, which have short half-lives and are typically manufactured at or near the imaging centers where they are used.

The March 7 communication allows research centers to follow a unique approval process for new PET drugs and new drug applications. Although the draft document is subject to a 90-day comment period, few changes are expected after two years of close negotiation with PET researchers.

The agency also announced approval of three drugs commonly used to create PET images of the heart, brain, and other structures. This week’s document approves sodium fluoride F-18 injection, rubidium chloride-2 injection, and fluorine-18 fluorodeoxyglucose (F-18-FDG) injection. Approval for N-13 ammonia and O-15 water are expected later this month.

“For the first set of drug approval procedures, the FDA did the analysis itself, because it would be hard for any one academic or research facility to have done the work necessary to prove safety and efficacy,” said Jennifer Keppler, executive director of the Institute for Clinical PET.