Letter to FDA on In Vivo Proposed Regulations

June 30, 2003

Letter to FDA on In Vivo Proposed Regulations

November 23, 1998

Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Drive
Room 1-23
Rockville, MD 20857

RE: Proposed Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; 63 FR 28301, May 22, 1998.

Dear Sir or Madam:

The American College of Nuclear Physicians (ACNP) and the Society of Nuclear Medicine (SNM) are pleased to provide comments to the Food and Drug Administration (FDA) on the proposed regulations governing radiopharmaceuticals. The ACNP and SNM represent over 12,000 physicians, technologists, pharmacists, and scientists in the Nuclear Medicine field. Radiopharmaceuticals are of vital import in our work. They are used in over 11 million diagnostic and therapeutic medical procedures each year.

We applaud the FDA?s efforts to work with the shareholder community. It was by far one of the most interactive endeavors undertaken between the FDA and the regulated industry. The FDA took every effort to understand the end-user and commercial concerns, and in general, this is reflected in the final document. ACNP and SNM cite specifically the agencies response to the language in Section 122 of the Food and Drug Administration Modernization Act of 1997. Section 122 required that the regulations developed provide for consideration of pharmacological and toxicological activity and estimated absorbed radiation dose during review. The proposal recognizes that the radiopharmaceuticals should be categorized based on defined risk characteristics for purposes of safety evaluation. This shift from the traditional method of reviewing drugs by the agency accurately reflects the inherent safety characteristics of radiopharmaceuticals.

ACNP and SNM recommend that FDA strengthen the language in the proposal as it pertains to the safety related provisions and how they would apply to radiopharmaceuticals that have not been previously approved for other indications. We believe, as does the Council on Radionuclides and Radiopharmaceuticals (CORAR), that pre-existing available information should be considered not only for radiopharmaceuticals that have been previously approved but also many that have not.

CORAR also raises several specific points in their comments that the FDA needs to address. ACNP and SNM support those comments by CORAR and urge FDA to implement the suggested changes prior to moving forward with a final rule. As mentioned above, ACNP and SNM represent the majority of physicians currently practicing nuclear medicine. Should the FDA be interested in gathering more information about the impact of this proposed regulation on the practice of nuclear medicine, the ACNP and SNM stand ready to assist.

If you have any additional questions or require more information please do not hesitate to contact Amanda Sullivan, at 703.708.9773.

Sincerely,

Robert L. Meckelnburg, M.D.
President
American College of Nuclear Physicians

James W. Fletcher, M.D.
President
Society of Nuclear Medicine