Because consideration of risk and benefit often depends on understanding the population perspective and review of observational studies and because drug safety problems are not reviewed only by DSaRM, the committee would like to ensure that the recommendations of advisory committees are based on a broad spectrum of disciplinary expertise.

4.9: The committee recommends that all FDA drug product advisory committees, and any other peer review effort such as mentioned above for CDER-reviewed product safety, include a pharmacoepidemiologist or an individual with comparable public health expertise in studying the safety of medical products.

In addition to concerns about advisory committee expertise and appropriate review, the committee shares concerns about the appearance of independence of advisory committees as it is affected by financial relationships of members with pharmaceutical or other private interests. In making the determination of whether a financial interest poses a conflict, FDA applies the terms of two statutes, 18 U.S.C. § 208, and 21 U.S.C. § 505(n). Under both, FDA may grant a waiver of any conflict of interest provided that some criteria are met. In addition, both statutes provide for public disclosure of financial interest information when a waiver has been granted (see 18 U.S.C. § 208(d)(1) and 21 U.S.C. § 355(n)(4)).

The guidance “FDA Guidance on Conflict of Interest for Advisory Committee Members, Consultants and Experts” describes the type and amount of information that is considered in deciding whether a financial interest presents a potential conflict of interest that needs to be merely disclosed or needs to be reviewed by the ethics staff for consideration of a waiver regarding a topic to be discussed by the advisory committee whose meeting the special government employee is attending (FDA, 2000). Table 4-2 describes key information considered as a level of financial interest that is transmitted to the ethics staff in a memo but does not require a waiver although it is disclosed to the public. For interests that exceed such levels, FDA uses a “sliding scale” to decide whether levels of conflict of interest are acceptable. Levels are different for participation in a “general matter”17


A particular matter of general applicability is a matter that is focused on the interests of a discrete and identifiable class of persons but does not involve specific parties. For example, a guidance document that affects an entire class of products and all similarly situated manufacturers is a matter of general applicability. In addition, the use of a potential product solely as a model or example for general discussion whose results will apply to a class of products may be a matter of general applicability.

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