MITA pushes for “one stability, one facility” in PET drug inspections

The Medical Imaging and Technology Alliance (MITA) with the Coalition of PET Drug Manufacturers is calling on the U.S. Food and Drug Administration (FDA) to maintain its “one stability, one facility” approach to PET drug inspections.

According to MITA, PET drug products undergo annual stability testing at a single manufacturing facility because the results are considered representative of batches manufactured at other facilities in the approved applications. The FDA's potential policy change regarding the One Stability, One Facility model does not appear to be associated with product safety or product performance concerns.

“PET drug manufacturers have rightly relied on this 'one stability, one facility' approach, which has been accepted by the FDA and has been the de facto standard in the PET drug manufacturing industry for years,” one said Letter from MITA dated September 13th.

“For reasons that have not been made clear to the industry, some FDA inspectors have recently sought to reprimand PET drug manufacturers for failing to conduct annual stability testing at each manufacturing facility – even though there were no regulations or written guidelines “setting out a change in the agency's expectations regarding stability testing for PET drug products…” the letter continues.

“This shift in the regulation of PET drug manufacturing could unnecessarily restrict patient access to radiopharmaceuticals, which are essential to providing accurate diagnosis and access to a range of therapies,” said Sue Bunning, managing director of MITA’s PET Group.

MITA is a division of the National Electrical Manufacturers Association (NEMA). The full position paper can be found here.