October 02, 2024

Arlington, Va. — The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is urging the Food and Drug Administration (FDA) to maintain its “one stability, one facility” approach to inspections for positron emission tomography (PET) drugs (MITA Letter to FDA Regarding Policy Changes on Stability Sept. 13 2024). MITA, in conjunction with the Coalition of PET Drug Manufacturers, recently created a position paper on this topic.

PET drug products have annual stability testing performed at a single manufacturing facility because results are considered representative of batches produced at other facilities in the approved applications. The FDA’s possible policy change regarding the “one stability, one facility” model does not seem to be linked to product safety concerns or product performance.

According to Sue Bunning, Managing Director of Positron Emission Tomography for the MITA PET Group, “This shift in regulating the manufacturing of PET drugs could unnecessarily limit patient access to radiopharmaceuticals which are essential to providing patients with an accurate diagnoses and access to a number of therapies. With positron emission tomography (PET), you cannot get the diagnosis without the drug.”

The MITA PET Group is the leading organization and collective voice of radiopharmaceutical manufacturers, innovators, and product developers.