Recent questions posed to the FDA regarding the requirement for INDs for PET drugs used in clinical trials has drawn a clarifying response from the FDA on its position.

In response to questions posed regarding the requirement for INDs for PET drugs used in clinical trials, the FDA issued a clarifying statement:

“FDA has received several inquiries about the continued use of PET drugs (fludeoxyglucose F18 injection, sodium fluoride F18 injection, and ammonia N13 injection) in ongoing clinical trials for new uses of these products or to support clinical trials of therapeutics, and many have expressed concerns that if INDs are required at this time for these drugs, hundreds of ongoing clinical trials and certain proposed trials may be disrupted or delayed. As a result of these inquiries and concerns, we think it is necessary to clarify our position regarding these trials.

FDA’s position is:

• If the PET drug used in the clinical trial is being made at a facility for which manufacturing data have been submitted in an NDA or ANDA for the PET drug, then FDA will not object to use of the PET drug without an IND until December 12, 2015, if this and the other requirements in 21 CFR 312.2 are met (see 21 CFR 312.2(b)).
• However, if significant manufacturing deficiencies are found during the NDA/ANDA review, or during inspection of the facility the PET drug is sourced from, FDA may notify the sponsor that the PET drug should no longer be used in clinical trials.

After December 12, 2015, investigational use of a PET drug must be covered by an IND unless it is exempt from all of the IND requirements.

We were also asked about what documentation must be provided to support an IND that is already in effect for a therapeutic drug which relies on a PET diagnostic drug to monitor disease progression or otherwise evaluate the efficacy of the therapeutic drug. For this scenario, before December 12, 2015, no CMC documentation for the PET drug needs to be submitted to the IND for the therapeutic drug as long as the PET drug is manufactured at a facility for which supportive manufacturing information has been submitted in an NDA/ANDA. After December 12, 2015, for PET drugs manufactured at facilities that are not named in an approved NDA or ANDA, CMC documentation for the PET drug will need to be submitted to the IND for the therapeutic drug.

Sponsors have asked other questions such as how an investigator will know whether an NDA/ANDA has been submitted and what records should be submitted to document that the PET drug was sourced from a facility named in a submitted NDA/ANDA. Documentation should be maintained at the trial site where the investigation is being conducted that indicates the number of the NDA/ANDA that contains the CMC data for the facility from which the drug is sourced. Over the next several months, clinical investigators should make sure this documentation is in place for the PET drugs used in their investigations.

We will be addressing these issues in guidance on investigational drugs as well as in a guidance responding to numerous questions we have received over the past several months. These guidances will be published in draft, and we will look forward to receiving comments from affected parties and making necessary revisions to the guidance as appropriate.”

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