Is the U.S. Food and Drug Administration (FDA) playing fair with radiopharmaceutical manufacturers when it comes to lab inspections?
This is a question raised by the Radiopharmaceutical Manufacturers and Theranostics Alliance (RMTA), a trade group that for 2026 evolved from the Medical Imaging Technology Alliance (MITA)'s PET Working Group. The change comes as radiopharmaceutical therapies are projected to expand greatly.
Uneven FDA inspections are one issue on the spectrum of radiopharmaceutical industry concerns, according to RMTA regulatory affairs and government relation insiders who met with AuntMinnie to discuss trends and issues. The call included RMTA Managing Director Sue Bunning, as well as RMTA chair Ann Marie Dawidczyk, and RMTA regulatory committee chair Ashley Mishoe.
Regulatory expectations
RMTA regulatory committee chair Ashley Mishoe.RMTA
Mishoe explained that some facilities are told everything is fine at inspection because they're using existing regulations. However, some are told to change, and the expectations are much different for them, she said. RMTA has pointed out specific issues related to precursor identity testing requirements and annual stability testing requirements.
"The industry is experiencing inconsistent FDA inspection expectations, including apparent policy shifts," said Mishoe, who also leads regulatory affairs for PharmaLogic, a contract development and manufacturing organization (CDMO) that specializes in radiopharmaceuticals.
"Policies are being implemented inspection by inspection rather than through guidance or rulemaking, which is causing a lot of uncertainty and ultimately risking patient access," Mishoe said. "This causes regulatory and operational inequities."
PET drug manufacturers have been relying on FDA Part 212 regulations derived from the agency’s PET drugs current good manufacturing practice (CGMP) final rule and following guidance, Mishoe explained.
Part 212 regulations are purposefully distinct from Part 210 and 211, which outline CGMP regulations for conventional drug manufacturing, according to Mishoe. The RMTA contends that the FDA has started demanding new testing requirements on incoming components for PET drugs during pre-approval inspections and application reviews.
On one hand, this impedes patient access to radiopharmaceuticals, the group said. On the other, it provides unfair competitive advantages to manufacturers who are provided FDA feedback on their production processes and can thereby adapt more quickly than other firms, they added. RMTA wants the FDA to maintain current Part 212 manufacturing standards.
Radioactive drugs, such as PET drugs, can include both drugs and biologics. FDA radiopharmaceutical chemistry review experts highlighted some of the nuances of regulatory compliance with precursor testing during a June 2 session at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting. While the FDA is expected to release new guidance documents related to GMP regulations, reviewers were not able to share details at SNMMI.
RMTA and Coalition of PET Drug Manufacturers have clarified the issues in letters to FDA policymakers. The organizations have made several requests, including creating a permanent role for a PET drug subject matter expert at the FDA, strengthening training around PET GMP, and implementing changes in a controlled fashion in accordance with established rulemaking procedures.
"These inconsistencies have at times created immense confusion for network-based PET drug manufacturers, who may receive conflicting feedback about the same processes at different site inspections," RMTA said in its letter. "The net effect is a tremendous expenditure of industry resources on attempting to come in line with shifting policies that have not been formally announced with little to no apparent positive return on product safety."
Just-in-time manufacturing
PET drugs generally have short half-lives -- a few hours or a few days -- so they must reach the patient for administration soon after they are produced.
"They're quite different from conventional drug products," Mishoe told AuntMinnie. "They require just-in-time manufacturing. They require localized production. They're typically made within a three- to four-hour driving radius to the local hospital in a patient's area."
The operational realities of manufacturing, dispensing, and distributing PET radiopharmaceuticals are unique, Mishoe noted. This is why the RMTA appealed to the U.S. Centers for Medicare and Medicaid Services (CMS) to improve payment accuracy through provisions in the calendar year (CY) 2027 Hospital Outpatient Prospective Payment System (HOPPS) policy, according to Dawidczyk.
RMTA has recommended CMS use average sales price (ASP) data reported by radiopharmaceutical manufacturers as the payment methodology in the hospital outpatient setting for diagnostic radiopharmaceuticals in 2027, where the radiopharmaceutical is above the cost threshold.
Manufacturers have demonstrated experience reporting ASP data for diagnostic radiopharmaceutical products paid through the transitional pass-through program, RMTA said in a May 7 letter to the CMS. When ASP is not available, payment is based on mean unit cost (MUC), the RMTA noted.
Hospital acquisition costs
RMTA chair Ann Marie DawidczykRMTA
Currently, CMS uses claims data to establish a mean unit cost (MUC) in the hospital outpatient setting for these drugs. The MUC does not appropriately reflect hospitals' acquisition costs when they purchase diagnostic radiopharmaceuticals, Dawidczyk stressed on the call with AuntMinnie.
"Payment based on average selling price, which is commonly known as ASP, would be more appropriate to pay for these precision diagnostic radiopharmaceuticals," Dawidczyk said. "We know that this data is available to CMS based on information from our membership and also from CMS's history of paying these innovative radiopharmaceuticals based on ASP when they first come to market for their first three years when they enter into a commercial period. Our goal is to continue the engagement."
Use of ASP information for OPPS payment could provide an opportunity to improve payment accuracy for separately payable diagnostic radiopharmaceuticals by applying an established methodology that has already been successfully implemented under the OPPS for other separately payable drugs and biologicals -- as well as therapeutic radiopharmaceuticals, according to RMTA in the letter.
"One key issue that we've been working on for a number of years, and we've seen progress as a result of our work with CMS, is the appropriate payment of diagnostic radiopharmaceuticals under Medicare in the hospital outpatient setting," Dawidczyk explained, noting traction gained in January 2025 when CMS made a change as a result of engagement with the former MITA PET Group.
"CMS previously bundled payment for diagnostic radiopharmaceuticals into a payment package under Medicare Part B," said Dawidczyk, who also works as head of government affairs at Lantheus Holdings. "As a result of a long and tumultuous path, CMS did decide to make a positive change to update their payment policy for diagnostic radiopharmaceuticals in January of 2025. However, we still are working with them to improve the policy."
Future rule-making
RMTA leaders say they are hopeful that CMS will address the issue through rulemaking anticipated this summer. RMTA recommended that CMS update the prior ASP reporting guidance for therapeutic and diagnostic radiopharmaceuticals, as well.
Updated guidance for ASP reporting for diagnostic radiopharmaceuticals will be important for any manufacturers that have not yet begun to report ASP, according to the RMTA. Importantly, the group suggested CMS solicit comments in rulemaking on how it can ensure consistent reporting for ASP. Although the group is encouraged, more work is to be done from a payment policy perspective, Dawidczyk noted.
So far, 18 companies have joined the RMTA, which is a division of the National Electrical Manufacturers Association (NEMA). Members include Blue Earth Diagnostics, Bracco, Cardinal, Curium, Enigma, Eli Lilly, ITM, GE HealthCare, Lantheus, PharmaLogic, and others.
"There has been a significant change in the nuclear medicine industry over the past few years," Bunning explained. "And over the more recent years, we have seen the FDA approval and use of PET drugs assisting in the diagnosis of diseases such as Alzheimer's, advanced cardiology, and various uses in of oncology such as prostate, breast, neuroendocrine cancer."
One of RMTA's most notable projects was managing parts of the Imaging Dementia Evidence for Amyloid Scanning (IDEAS) study for Alzheimer's disease, in collaboration with the Alzheimer's Association and others, Bunning noted. Evidence from this study contributed to the CMS decision to cover amyloid PET scans, she said, adding that the work continues for the variety of radiopharmaceuticals cleared today.
For the latest in radiopharmaceutical activity, refer to AuntMinnie's Radiopharmaceutical (RPT) Tracker and full coverage of SNMMI 2026 here.
