# Presentation: 713388

## Membership and Administrative Issues Public Meeting“Radioactive Drugs for Certain Research Uses”

**Richard M. Fejka**
**MS, RPh, BCNP**
**RDRC program oversight**
**Food and Drug Administration**
**November 16, 2004**

## BACKGROUND

**21 CFR 361.1 (c) (1) *****Membership***
- A Radioactive Drug Research Committee shall consist of at least 5 individuals.
- Each Committee shall include the following 3 individuals:
- (i) a physician recognized as a specialist in nuclear medicine,
- (ii) a person qualified by training and experience to formulate radioactive drugs,
- (iii) a person with special competence in radiation safety and radiation dosimetry. ...

## MEMBERSHIP ISSUE #1as it relates to pharmacological dose determination

- 21 CFR 361.1 (b) (2) ***Limit on pharmacological dose**** *states* *“The amount of active ingredient or combination of active ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings. ...”
*AND *in
- 21 CFR 361.1 (d) (2)* ****Pharmacological dosage**** states *“To determine that the amount of active ingredients to be administered does not exceed the limitations set forth in paragraph (b)(2) of this section, the committee shall require that the investigator provide pharmacological dose calculations based on data available from published literature or from other valid human studies.”

## MEMBERSHIP ISSUE #1as it relates to pharmacological dose determination

**QUESTIONS:**
- Would an RDRC benefit from additional expertise such as from a pharmacologist or toxicologist?
- Should FDA require a member with specific expertise to determine that the proposed pharmacological dose does not cause a clinically detectable effect?

## MEMBERSHIP ISSUE #1as it relates to pharmacological dose determination

- 21 CFR 361.1 (c) (2) *Function**** ***states “... Each committee shall meet at least once each quarter in which research activity has been authorized or conducted. A quorum consisting of more than 50 percent of the membership must be present with appropriate representation of the required fields of specialization. ...”
- realize,
- If the addition of another required member is acceptable, then the minimum number of committee members will increase from 5 to 7.
**We are seeking your comments on this issue.**

## MEMBERSHIP ISSUE #2as it relates to the radioactive drug formulator

- 21 CFR 361.1 (c) (1) *Membership (ii) *requires each committee include “a person qualified by training and experience to formulate radioactive drugs,”
- 21 CFR 361.1 (d) (6) *Quality of radioactive drug* addresses the expectation for the RDRC to assure appropriate and reproducible drug quality and to determine that the radioactive materials for parenteral use are prepared in sterile and pyrogen-free from,
- 21 CFR 361.1 (d) (7) *Research Protocol* requires the RDRC review a protocol which _***IS***_ to address _***ALL***_ requirements of section (d),

## MEMBERSHIP ISSUE #2as it relates to the radioactive drug formulator

**Questions:**
- Should the member “qualified by training and experience to formulate radioactive drugs” who undertakes the review specified in section (d) (6) as required in section (d) (7) be more explicitly defined, e.g. a nuclear pharmacist, or chemist or nuclear medicine technologist?
- What level of training and experience is necessary for this member to possess?

## ADMINISTRATIVE ISSUE #1changes in Committee membership

- 21 CFR 361.1 (c) (4) *Approval *states “...Changes in membership and applications for new members shall be submitted to the FDA as soon as, or before, vacancies occur on the committee.”
- FDA is concerned that unqualified members may be serving on a RDRC as a result of untimely notification to FDA of changes in committee membership.
**QUESTION:**
- Should the regulations specifically require that FDA approve RDRC membership changes before new members assume committee responsibilities?

## ADMINISTRATIVE ISSUE #2withdrawal of a Committee’s approval

- 21 CFR 361.1 (c) (4) *Approval *states “... Approval of a committee may be withdrawn at any time for failure of the committee to comply with any of the requirements of this section.  Approval of a committee shall remain effective unless and until the FDA withdraws such approval. ...”
**QUESTION:**
- What level of non compliance of a RDRC should necessitate FDA to withdraw a committee’s approval for their failure to comply with any of the requirements of 21 CFR 361.1?

## ADMINISTRATIVE ISSUE #3“Inactive” committee status

- Historically, FDA has allowed a committee to be placed on “inactive” (not required to submit an annual report) status upon request.  FDA is proposing to amend the regulations to allow this.
**Comments?**