Developers of PET radiopharmaceuticals got a reprieve this week: The U.S. Food and Drug Administration (FDA) announced that it will give them six more months to comply with an upcoming rule change for manufacturing PET drugs that originally was scheduled to go into effect next week.
Instead of the new rules going into effect on December 12, the FDA is delaying them until June 12, 2012, the deadline for PET drug manufacturers to submit a new drug application (NDA) for their radiopharmaceuticals. Until then, facilities must comply with all other FDA requirements, including current good manufacturing practices (cGMPs).
The agency also postponed any enforcement actions against PET drug manufacturers that aren't complying with the new rules until after the June deadline.
The most recent FDA announcement comes following requests from some PET drug manufacturers, which expressed concern that if they were unable to submit their applications by the December 12 deadline, production of PET drugs could cease.
The PET drug manufacturers were originally given notice in December 2009 to submit NDAs or abbreviated new drug applications (ANDAs) for their products. The now two-year-old final rule on cGMPs covers all PET drug producers, including those affiliated with hospitals and academic medical centers, as well as unaffiliated regional manufacturers.
While the FDA did not anticipate any PET drug shortages due to the December 12 deadline, the agency stated that it was "concerned" that producers in isolated areas might stop manufacturing this month, which could cause supply issues and hardship for patient care.
"Therefore, if a facility wishes to continue to produce PET drugs for clinical use after June 12, 2012, they must have submitted a new drug application or an abbreviated new drug application by that date, or be producing the drugs under an investigational new drug exemption," the FDA indicated.
If PET producers are unable to submit an NDA or ANDA by June 12, 2012, or operate under an investigational new drug (IND) application, they must find a new supplier that has submitted an NDA or ANDA, the communiqué added.
All PET producers must operate under an approved NDA or ANDA or effective IND by December 12, 2015.
