The Medical Imaging and Technology Alliance (MITA) with the Coalition of PET Drug Manufacturers is urging the U.S. Food and Drug Administration (FDA) to maintain its “one stability, one facility” approach to inspections for PET drugs.
PET drug products undergo annual stability testing at a single manufacturing facility because results are considered representative of batches produced at other facilities in the approved applications, according to the MITA. 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.
"PET drug manufacturers have justifiably relied upon this 'one stability, one facility' approach, which had been accepted by the FDA and has been the de facto standard in the PET drug manufacturing industry for years," a September 13 letter from the MITA stated.
"For reasons that have not been made clear to the industry, some FDA inspectors have recently attempted to issue observations to PET drug manufacturers for failing 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 regarding stability testing for PET drugs ...," the letter continued.
“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 diagnosis and access to a number of therapies," said MITA's PET Group managing director Sue Bunning.
The MITA is a division of the National Electrical Manufacturers Association (NEMA). Find the full position paper here.
