Bob Latta: “I include in the Record this Statement of Intent on Data Required for General Recognition of Safety and Effectiveness.…”

“I include in the Record this Statement of Intent on Data Required for General Recognition of Safety and Effectiveness. The OTC drug monograph reform legislation requires that nonprescription drugs be shown to be generally recognized as safe and effective. This standard of general recognition is based on statutory language that has been in the Federal Food, Drug, and Cosmetic Act since its enactment in 1938, and it was incorporated in the regulations issued by the Food and Drug Administration when the OTC Drug Review was established in 1972. In particular, 21 CFR 330.10(a)(4)(i) states that: . . . Proof of safety shall consist of adequate tests by methods reasonably applicable to show the drug is safe under the prescribed, recommended, or suggested conditions of use. This proof shall include results of significant human experience during marketing. General recognition of safety shall ordinarily be based upon published studies which may be corroborated by unpublished studies and other data. Similarly, 21 CFR 330.10(a)(4)(ii) states that: . . . Proof of effectiveness shall consist of controlled clinical investigations as defined in Sec. 314.126(b) of this chapter, unless this requirement has been waived on the basis of a showing that it is not reasonably applicable to the drug or essential to the validity of the investigation and that an alternative method of investigation is adequate to substantiate effectiveness.…”