Syncor sues feds over NDA policyfor cyclotron-based PET tracers

Legal move symbolizes industry's frustration with regulations

The Food and Drug Administration's new policy on the regulationof radiopharmaceuticals used in PET imaging has spurred at leastone company to drastic action. Radiopharmacy firm Syncor Internationalfiled a lawsuit against the FDA late last month, charging thatthe powerful federal agency has overstepped its bounds by requiringproducers of cyclotron-based PET radiopharmaceuticals to obtainnew drug applications (NDAs) before their products can be usedclinically.

Syncor's move is unusual, but is a symbol of the increasingfrustration the medical community is experiencing with the FDA'spolicy. The litigation could be the first shot in a major regulatoryturf battle between the FDA on one hand and industry and the stateson the other over who has the right to regulate PET radiopharmaceuticals.

The FDA announced the NDA policy in several notices publishedFeb. 27 in the Federal Register (SCAN 3/15/95). In short, theagency stated that it would extend its authority over PET radiopharmaceuticalsproduced in cyclotrons and require such drugs to receive NDAsor abbreviated NDAs before they can be used in clinical settings.Previously, cyclotron-produced PET drugs were governed by statepractice of pharmacy laws. The FDA said the new rules would takeeffect 18 months after the publication of the Federal Registernotices.

The PET community immediately cried foul, charging that theFDA's move was an unreasonable and unnecessary intrusion of federalregulation that could kill the commercial PET industry. Severalgroups began a lobbying effort to combat the regulations and sponsoredlegislation in Congress to return regulatory jurisdiction overPET radiopharmaceuticals to the states (SCAN 5/10/95).

Syncor's move opens up another front in the battle. On Aug.24, the Chatsworth, CA-based company filed suit in U.S. DistrictCourt in Washington, DC, naming as defendants Secretary of Healthand Human Services Donna Shalala and FDA Commissioner David Kessler.The lawsuit charges that the FDA's policy on PET agents is unlawfulon several grounds:

• The FDA adopted the NDA regulations without meeting therequisite notice and comment provisions of the federal AdministrativeProcedure Act;

• The agency does not have the authority to regulate the compoundingof drugs that do not move in interstate commerce; and

• The FDA's policy violates the 10th Amendment to the U.S.Constitution, which gives to the states all powers not expresslyreserved for the federal government.

According to Syncor, the Feb. 27 Federal Register announcement,although called a notice, was actually a substantive rule thatshould have been accompanied by certain notice and comment provisionsof the Administrative Procedure Act. Syncor cited the strict wordingof the announcement to support its allegations, and also saidthat the FDA never responded to comments on the policy from Syncorand others, also a violation of the Administrative Procedure Act.

On the second charge, Syncor cited passages from the FederalFood, Drug and Cosmetic Act, which proscribes the introductionof unapproved drugs in interstate commerce. PET radiotracers,because of their short half-lives, are rarely shipped across statelines and thus are not subject to the act's provisions, accordingto Syncor's complaint.

Finally, Syncor said the FDA rules violate the 10th Amendmentbecause the regulation of pharmacy traditionally is not a powerdelegated to the federal government by the Constitution, but ratheris a police power given to state authorities. To support its argument,Syncor cited a letter sent to the FDA in 1990 by the Californiaattorney general's office, stating that the compounding of PETradiotracers is governed by the state's practice of pharmacy lawsas long as the drugs are used in the institution where they arecompounded.

Syncor requested that the court declare null and void the FDA'splan to regulate PET radiotracers as outlined in the Feb. 27 FederalRegister notice. The company also asked the court to declare thata state-licensed pharmacy may compound PET radiotracers accordingto a physician's prescription for intrastate commerce withoutregard to the provisions of the Food, Drug and Cosmetic Act. Syncoralso asked for a declaration that the 10th Amendment bars theFDA from defining the scope of the practice of pharmacy.

The FDA's rules would affect four Syncor pharmacies that areproducing PET radiopharmaceuticals, according to Haig Bagerdjian,Syncor vice president and general counsel. Syncor decided to filethe suit after exhausting other avenues of protest, he said.

"We did not take lightly filing a lawsuit against an agencyof the federal government," Bagerdjian said. "Two yearsago we filed a petition, and there was no response to it. We feelvery strongly and are confident in our case, otherwise we wouldnot have filed this lawsuit."

Syncor hopes to bring its litigation to a resolution beforethe FDA's 18-month deadline falls, which would be in August 1996.The FDA has 60 days after the filing date of the lawsuit to respond,Bagerdjian said.