Syncor wins appeal of FDA lawsuit

Radiopharmacy company Syncor International scored wins on two fronts in the company's battle with the Food and Drug Administration over regulation of PET radioisotopes. In addition to FDA reform legislation that removed the agency's authority over PET tracers, Syncor won its appeal of a lower court ruling regarding FDA regulation of radioisotopes such as fluorodeoxyglucose.

Syncor challenged the FDA's decision in 1995 to require all producers of cyclotron-based PET radioisotopes to receive new drug applications (NDAs) before their products could be clinically used. Previously, such tracers were regulated under state practice-of-pharmacy rules. Syncor claimed that the FDA's move overstepped its authority and violated its own rule-making procedures, according to Haig Bagerdjian, general counsel for the Woodland Hills, CA, company.

Syncor's case suffered a setback earlier this year, when a U.S. District Court judge ruled in favor of the FDA (SCAN 2/5/97). Syncor was successful, however, in its appeal of that ruling: In October, a three-judge panel of the U.S. Court of Appeals in Washington, DC, overturned the lower court's ruling, finding that the FDA did violate the rule-making regulations.

Syncor's position was reinforced by the FDA reform bill that passed in November, which included specific provisions removing the FDA's authority to regulate PET radioisotopes. The FDA has tried to use that setback to its advantage in the Syncor lawsuit, however, and is asking the Court of Appeals to vacate its October ruling on the grounds that the decision has been rendered moot by the reform legislation. Syncor is fighting the motion, which is under consideration by the court, according to Bagerdjian.