Syncor Intern. Corp. v. Shalala

• Decision Date: 28 October 1997
• Docket Number: No. 96-5371,96-5371
• Citation: 127 F.3d 90
• Parties: SYNCOR INTERNATIONAL CORPORATION, et al., Appellants, v. Donna E. SHALALA, Secretary of Health and Human Services, et al., Appellees.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 90

127 F.3d 90 326 U.S.App.D.C. 422 SYNCOR INTERNATIONAL CORPORATION, et al., Appellants,
v.
Donna E. SHALALA, Secretary of Health and Human Services, et
al., Appellees. No. 96-5371. United States Court of Appeals,
District of Columbia Circuit. Argued Sept. 11, 1997.
Decided Oct. 28, 1997.

Page 91

[326 U.S.App.D.C. 423] Appeal from the United States District Court for the District of Columbia (95cv1627).

Alvin J. Lorman, Washington, DC, argued the cause for appellants, with whom Gregory R. Firehock was on the briefs.

Jay I. Bratt, Attorney, United States Department of Justice, Washington, DC, argued

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[326 U.S.App.D.C. 424] the cause for appellees, with whom Frank W. Hunger, Assistant Attorney General, and Eric H. Holder, Jr., U.S. Attorney at the time the briefs were filed, were on the brief.

Before: SILBERMAN, ROGERS and TATEL, Circuit Judges.

Opinion for the Court filed by Circuit Judge SILBERMAN.

SILBERMAN, Circuit Judge:

Appellants Syncor International Corporation, American College of Nuclear Physicians, Society of Nuclear Medicine, and American Pharmaceutical Association (collectively, Syncor) appeal the district court's decision that FDA's 1995 "Notice," entitled "Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public Workshop," was a "non-substantive" rule not subject to notice and comment rulemaking. We reverse.

I.

Positron emission tomography (PET) is a diagnostic imaging method that uses a subset of radioactive pharmaceuticals, called PET drugs, to determine biochemistry, physiology, anatomy, and pathology within various body organs and tissues by measuring the concentration of radioactivity in a targeted area of the body. The active component of PET drugs is a positron-emitting isotope. ¹ This component has a short half-life, so the drug remains effective for only brief periods of time. As a consequence, PET drugs are not manufactured by pharmaceutical companies; instead, they are prepared by physicians and pharmacists operating accelerators in facilities known as nuclear pharmacies, which most often are part of major teaching hospitals or their adjacent universities, and always are located very near to the place where the PET drug will be administered to patients. These nuclear pharmacists compound the isotope with a chemical solution called a substrate. The substrate is used to carry the isotope to the targeted organ or tissue, and the precise solution used depends on the targeted area. For example, a nuclear pharmacist might combine an isotope with a glucose substrate if the brain was being targeted, since the brain is an area of high glucose uptake. In part for this reason, PET drugs are compounded pursuant to a prescription.

On February 25, 1995, FDA announced that PET radiopharmaceuticals "should be regulated" under the drug provisions of the Federal Food, Drug, and Cosmetic Act. ² In this publication, labeled a "Notice," and referred to alternatively in its text as "guidance" and a "policy statement," FDA indicated that it would require PET "radiopharmaceutical manufacturers" to comply with the adulteration provision of § 501(a)(2)(B) of the Act (drugs are considered adulterated unless manufactured in conformance with current good manufacturing practices); the misbranding provision of § 502 of the Act (drugs are considered misbranded if the product labeling is false or misleading, if the drug is dangerous to health when used as suggested in the labeling, or if the labeling fails to include certain required information); the new drug provision of § 505 of the Act (new drugs must be the subject of approved new drug applications or abbreviated new drug applications before marketing); and the registration and listing provisions of § 510 of the Act (drug establishment must register with FDA, and file a list of all drugs that it makes or processes). See Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public Workshop, 60 Fed.Reg. 10594, 10595 (1995).

FDA indicated that its 1995 publication was to supersede its prior 1984 publication--directed at all nuclear pharmacies, not just those compounding PET radiopharmaceuticals

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[326 U.S.App.D.C. 425] --entitled "Nuclear Pharmacy Guideline; Criteria for Determining When to Register as a Drug Establishment." The 1984 Guideline had unequivocally stated that nuclear pharmacists who operated an accelerator to produce radioactive drugs to be dispensed under a prescription--which precisely describes the process by which nuclear pharmacies compound PET radiopharmaceuticals--were not required to register under § 510 of the Act. The Guideline also indicated that if a nuclear pharmacist was not required to register, that other of the Act's requirements, including the new drug provision and compliance with current good manufacturing practices, would not apply.

Syncor filed suit in the district court challenging FDA's 1995 publication. Syncor brought three claims...