Twelve years after the FDA first got involved in PET drugs, they've at last released final rules controlling their manufacture - rules which could place a burden on smaller drug producers, according to an industry group.

The rules, released by the FDA this month, include both binding regulations and non-binding suggestions (called guidance) for how PET drug makers can meet current good manufacturing practices (cGMP) for the production of nuclear medicine drugs.

The rules, intended to control the purity and quality of PET agents, will go into effect about two years from date of publication, or Dec. 11, 2011. By that time, all manufacturers of PET drugs for human clinical use - and not just for experiments - must file new drug applications (NDAs) or abbreviated new drug applications (aNDAs) with the agency. PET drug makers whose products are only intended for experimental use will still follow the United States Pharmacopeia protocols, which all PET drug makers should still follow until these new rules take effect.
Although in general the industry seems to welcome quality-control measures, there are some red flags.

"I think it's good some guidelines are out, but they may be a little onerous, and this is what we need to discuss both within the nuclear medicine community and with the FDA, to understand exactly how they're going to be applied within the industry," Michael Graham, Ph.D., M.D., president of the Society of Nuclear Medicine, tells DOTmed News.

Burden for small players

PET drugs are currently manufactured in either big commercial plants or at small academic and hospitals sites, where batches are made for daily use in their own cyclotrons.

"I don't think [the rules will] be a burden for the large manufacturer. But there are concerns that if every site has to do it, it will be a burden. It certainly is going to be a manpower burden on the academic and small hospital sites to have to do that," says Dr. Graham, referring to efforts required to comply with the new regulations.

Still, although these are supposed to be final rules, there are some uncertainties in how they're going to be implemented. "We'll be having a significant meeting with the FDA at our mid-winter meeting at the end of January, and we'll have a fair amount of discussion with them at the time," says Dr. Graham. SNM's mid-winter meeting takes place in Albuquerque, N.M. Feb. 1-2, 2010.

FDA's involvement

The FDA first got authorized to investigate PET drugs quite recently, in 1997, after the passage of the Food and Drug Administration Modernization Act. Though originally they were supposed to develop regulations after only two years, it has taken them almost 12.

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