Molecular imaging and nuclear medicine stakeholders are making the case that proposed policy changes from the FDA could dramatically increase cost and decrease availability for radiopharmaceuticals — and they say no justification for the change has been provided.

PET radiopharmaceuticals in the U.S. currently undergo annual stability testing at a single manufacturing facility because results are considered representative of batches produced at other facilities in the approved applications. This is known as the “one stability, one facility” approach, and it is predicated on facilities using identical raw materials, components, container-closure, equipment, product synthesis, production and analytical procedures, personnel qualification, and change controls.

However, during a workshop on regulatory and compliance issues in November 2023, the FDA adopted a different position on stability testing, highlighting the need for PET manufacturers to perform stability testing at every manufacturing facility on an annual basis — despite the absence of any regulations or written guidelines specifying a change in the agency’s expectations.
MITA, in conjunction with the Coalition of PET Drug Manufacturers, issued a position paper summarizing the potential impact of the change and stressing that it does not appear to be linked to any product safety or performance concerns.

The coalition estimates the new model amounts to a 1,400% increase in the number of stability batches, and additional costs of approximately $3 million each year across the commercial manufacturing supply chain.

These additional costs do not account for lost revenue caused by supply interruptions due to stability studies, the paper notes. Since the commercial market for PET drugs is approximately $400 million/year, the cost for the additional stability studies represents 0.8% of the total market.

"Absent a product performance driver, a change of this magnitude should be generally based on science-based risk assessments," they wrote. "Based on the lack of publicly available information, no such risk assessment is readily available to the PET manufacturing community."

Beyond the financial burden, the groups say this change could disrupt drug production schedules and lead to delays in patient access to vital diagnostic procedures.

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