Based on information provided to the committee by industry and the FDA, it seems likely that regulatory approval for new sources of LEU-produced Mo-99/Tc-99m would require at least 4 months and as long as 18 months depending on the quality of the application and issues raised by the FDA during the review process. The cost of the process is difficult to estimate but would likely be in the range of multiple tens to hundreds of thousands of dollars.
It is important to recognize that these cost estimates represent only the direct costs for regulatory approvals. There are also likely to be indirect costs for such approvals, including, for example, any opportunity costs associated with lost sales of Mo-99, technetium generators, or radiopharmaceutical kits as a result of the regulatory process. However, these regulatory costs are likely to be small in comparison to the physical costs of conversion.
Three important regulatory considerations for converting Mo-99 production from HEU targets to LEU targets are described and discussed in this chapter: (1) physical security for HEU, (2) drug quality and purity, and (3) commercial sale of radiopharmaceuticals manufactured from Mo-99. On the basis of this information, the committee finds that:
Converting from HEU- to LEU-based production is unlikely to produce substantial savings in security costs, including transportation security costs.
The purity of Mo-99 produced from HEU targets and LEU targets is not significantly different. Mo-99 produced from LEU targets using standard production methods and practices can meet regulatory requirements for use in radiopharmaceutical production.
FDA approval for LEU-based production of Mo-99 should not be a substantial barrier to conversion. Such approvals would require at least 4 months and as long as 18 months depending on the quality of the application and issues raised by the FDA during the review process. The cost of the process is likely to be in the range of multiple tens to hundreds of thousands of dollars. Clinical testing is unlikely to be required by the FDA for such approvals.