Policy affects Syncor's P.E.T.Net joint ventureRadiopharmacy firm Syncor International of Chatsworth, CA, isplanning to appeal a U.S. District Court judge's ruling that dismissedthe company's lawsuit against the Food and Drug
Policy affects Syncor's P.E.T.Net joint venture
Radiopharmacy firm Syncor International of Chatsworth, CA, isplanning to appeal a U.S. District Court judge's ruling that dismissedthe company's lawsuit against the Food and Drug Administrationregarding federal regulation of radiopharmaceuticals used in PETimaging.
Syncor filed the suit in 1995 in U.S. District Court for the Districtof Columbia, charging that the agency overstepped its authoritywhen it decided to require producers of cyclotron-based radiopharmaceuticalsto obtain new drug applications (NDAs) before their products canbe used clinically (SCAN 9/13/95). If the policy stands, it couldhave a major impact on Syncor by requiring radiopharmacies inits P.E.T.Net joint venture to file for NDAs. Syncor formed P.E.T.Netlast year in cooperation with cyclotron developer CTI of Knoxville,TN.
In its lawsuit against the FDA, Syncor claimed that because cyclotron-producedradiopharmaceuticals are typically not shipped beyond state lines,their regulation should be governed by state practice of pharmacylaws. Syncor also objected to the manner in which the FDA adoptedthe NDA policy. Joining Syncor in the lawsuit were the AmericanCollege of Nuclear Physicians, the Society of Nuclear Medicine,and the American Pharmaceutical Association.
U.S. District Judge Emmet Sullivan disagreed with Syncor's reasoning,however, and granted the FDA's motion for summary judgment, dismissingthe case. In deciding in the FDA's favor, Sullivan ruled thatthe agency's regulation of PET is admissible because while a finishedPET radiopharmaceutical does not move in interstate commerce,its components do. Sullivan also disagreed with Syncor's argumentsin other areas of the case.
Syncor vice president and general counsel Haig Bagerdjian disputedSullivan's reasoning.
"He really missed the point of the facts the way they werepresented," Bagerdjian said. "It showed a lack of understandingof the nuance of the law."
Syncor filed an appeal of the ruling in December in the U.S. Courtof Appeals for the District of Columbia. Syncor hopes to havethe appeal heard in the next three to six months, according toBagerdjian.
In other Syncor news, the company on Jan. 24 announced the signingof a major contract with VHA of Irving, TX, to supply the grouppurchasing organization with unit-dose and bulk radiopharmaceuticalson a nationwide basis. The deal has a potential value of about$270 million over four years and supersedes a three-year contractthat expired Dec. 31.