Syncor presents appeal of PET rules

September 17, 1997

Radiopharmacy firm Syncor International last week presented oral arguments in its appeal of a lower court ruling that dismissed the company's effort to overturn the way the Food and Drug Administration regulates PET radioisotopes. Syncor attorneys

Radiopharmacy firm Syncor International last week presented oral arguments in its appeal of a lower court ruling that dismissed the company's effort to overturn the way the Food and Drug Administration regulates PET radioisotopes. Syncor attorneys believe their presentation before the U.S. Court of Appeals in Washington, DC, went well, with the three-judge panel asking numerous questions as to whether the FDA followed the correct procedures in implementing the rules.

Syncor of Chatsworth, CA, filed suit against the FDA in 1995, charging that the FDA overstepped its authority and violated its own rule-making procedures when it decided to require producers of cyclotron-based radiopharmaceuticals to acquire new drug applications (NDAs) before their products could be used in clinical situations. The suit was dismissed late last year by Judge Emmet Sullivan of the U.S. District Court for the District of Columbia.

Syncor counsel Haig Bagerdjian said that the panel appeared to understand the issue better than Sullivan had, and directed most of its questions to the issue of whether the FDA violated its own rule-making procedures. While Syncor was heartened by the direction of the questioning, there's no guarantee that the panel will rule in the company's favor, Bagerdjian said. The appeals court typically hands down rulings in 90 to 180 days, although the panel may act sooner than that because the case comes at the beginning of its calendar.