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PET RADIOPHARMACEUTICALS: FDA PROPOSING REGULATION

Executive Summary

PET RADIOPHARMACEUTICALS: FDA PROPOSING REGULATION of the positron emission tomography (PET) agents through a system based on NDA and ANDA approvals. FDA Radiopharmaceutical Division Director John Palmer, MD, announced the plans at FDA's Radiopharmaceutical Drugs Advisory Committee meeting Nov. 21. Currently, the agents are not regulated by the agency. FDA has been working for at least a year on a regulatory approach to the radiopharmaceuticals, which are produced by PET users with an on-site cyclotron. At the committee's meeting last November, Palmer announced the agency's intent to take a more active role in the regulation of PET radiopharmaceuticals. Under the proposal, PET radiopharmaceuticals would be exempt from investigational new drug (IND) requirements until enough data on their clinical utility was collected to support safety and efficacy of the drugs. Once a hospital or other PET center feels that it has collected enough safety and efficacy data, it can submit an NDA. FDA would then place a notice in the Federal Register stating the conditions of approval and inviting ANDAs for other PET users that are producing similar radiopharmaceuticals. Several committee members commented that the proposed system would be overly burdensome to centers using PET technology. The committee also expressed concern that centers may have to do expensive and time consuming studies - possibly looking at the outcome of PET imaging and not just use of the agent in a PET device - in order to get enough data to support an NDA. Palmer told the committee that the intent of the proposal is not to require much more data than centers already gather in determining the utility of a new agent. "What we're really talking about is, you do pretty much what you would do anyhow to prove the point of effectiveness on a product [and] to produce the product appropriately," Palmer said. "But," he continued, "FDA can make the contribution of structuring this and giving it direction without creating a lot of extra noise." Palmer added that even if there would be some extra work involved with the regulatory approach, "the payoff comes in a more coordinated approach toward drug development." The proposal is still in the formative stages. FDA indicated that it would consider additional suggestions from the advisory committee before making formal plans for the regulation of the radiopharmaceuticals.
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