Congress takes on FDA’s PET regulation

April 2, 1997

The Food and Drug Administration's regulation of radioisotopes used in PET imaging has drawn the ire of Congress. Three members of the House of Representatives are circulating a "Dear Colleague" letter that urges support for legislation that would

The Food and Drug Administration's regulation of radioisotopes used in PET imaging has drawn the ire of Congress. Three members of the House of Representatives are circulating a "Dear Colleague" letter that urges support for legislation that would expressly remove the FDA's authority to regulate PET products.

The FDA has ruled that it has the authority to regulate PET radioisotopes produced in cyclotrons, and has proposed regulations requiring each isotope-producing site to receive new drug applications (NDAs) or abbreviated NDAs before their products can be used clinically. Opponents of the FDA's policy, however, believe that PET radioisotopes should be regulated under state practice of pharmacy rules. The FDA's policy prompted radiopharmacy firm Syncor International of Chatsworth, CA, to file suit against the FDA in 1995. A U.S. District Court decided in favor of the FDA late last year (SCAN 2/5/97).

The Dear Colleague letter was issued Feb. 27 by Rep. Richard Burr (R-NC), Rep. Gary Condit (D-CA), and Rep. Tom DeLay (R-TX). They are soliciting co-sponsors for the Pharmacy Compounding Act of 1997 (HR 1060), which would give the states regulatory authority over pharmacy compounding. It also includes a section that would withdraw the FDA's regulations regarding PET radioisotopes.