American College of Nuclear Physicians (ACNP)

1. American College ofNuclear Physicians (ACNP) Presentation on RDRC Membership By Terence Beven, M.D. Chair, ACNP-SNM Joint Government Relations Ctte. and ACNP Past President

2. RDRC Membership:Suggestions from ACNP Background: • ACNP is comprised of physicians and others dedicated to enhancing the practice of nuclear medicine through the study, education and improvement of clinical practice. Founded in 1974, The College provides access to activities that encompass the business and economics of nuclear medicine as they impact nuclear medicine physicians. • ACNP is a trade association that directly represents the interests of nuclear medicine physicians before legislative and regulatory bodies, other medical organizations, the media and general public. • ACNP’s mission is to assure a legislative, legal, regulatory and economic framework that encourages and makes practicable the safe, appropriate use of nuclear medicine procedures to improve the quality of health care service available to patients.

3. RDRC Membership:Suggestions from ACNP • ACNP is a supporter of the RDRC, and recognizes RDRC’s contributions to both nuclear medicine physicians and the patients that we serve. • The College welcomes any opportunity to work more closely with FDA staff to improve the function and effectiveness of the RDRC.

4. RDRC Membership:Suggestions from ACNP • ACNP believes that the RDRC benefits greatly from current requirements that it be minimally comprised of • A nuclear medicine physician; • A person qualified to formulate radioactive drugs; and • A person with special competency in radiation safety and radiation dosimetry.

5. RDRC Membership:Suggestions from ACNP • ACNP believes that the RDRC would benefit by including the following in its membership, depending on the nature of the research under consideration: • A pharmacologist • A nuclear medicine physician with substantial experience in PET and/or PET-CT • A clinician with expertise in the area being studied

6. RDRC Membership:Suggestions from ACNP RDRC Membership: Rationale for additional members: Pharmacologist Could provide expertise on the in-vivo actions of drugs when used in very small quantities

7. RDRC Membership:Suggestions from ACNP • ACNP’s rationale for including a nuclear medicine physician experienced with PET and/or PET-CT in the RDRC is: • A number of RDRC proposals will deal with ongoing PET research projects (molecular imaging probes)

8. RDRC Membership:Suggestions from ACNP • ACNP believes that it would be better to have FDA approve RDRC staff changes because: The work of the RDRC’s may be delayed if unqualified individuals were appointed and removed after the fact by FDA

9. RDRC Membership:Suggestions from ACNP • ACNP believes that it would be better to have RDRC membership changes reviewed jointly by FDA staff and representatives of provider interests (ACNP, SNM, etc.), because: This would serve to avoid disputes re. Qualifications of prospective members.

10. RDRC Membership:Suggestions from ACNP • RDRC provides CV of proposed member to FDA • FDA staff review of qualifications • Notify RDRC of decision within 30 days • RDRC acts on status of proposed member