Prescription drug ads need true brief summary, with broadcast alternative

Rule

Unless exempt as a reminder, bulk-sale, or prescription-compounding advertisement under 21 CFR 202.1(e)(2), a prescription drug advertisement (as defined by FD&C Act section 503(b)(1) or 21 CFR 201.105) must present a true brief summary of side effects, contraindications, and effectiveness that accurately reflects required, approved, or permitted labeling. For advertisements broadcast through radio, television, or telephone communications systems, 21 CFR 202.1(e)(1)(i) imposes two conjunctive obligations: (A) the major statement of major side effects and contraindications must be included in the audio or audio-and-visual parts of the presentation, with no exception for adequate provision; and (B) a brief summary of all necessary side effect and contraindication information must also be contained, unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation. The 'adequate provision' alternative excuses only the brief summary under (B) and never excuses the major statement under (A).

Check

First determine whether the ad qualifies for an exemption under 202.1(e)(2), tested against its stated conditions rather than by label alone: for reminder ads, confirm the ad contains only the elements enumerated in (e)(2)(i) (proprietary name, established name of the product and of each active ingredient, and, optionally, quantitative ingredient statement, dosage form, package quantity, price, and manufacturer/packer/distributor name and address), that it includes no indications or dosage recommendations, and that the product's labeling contains no boxed warning for a serious hazard (unless the ad conveys price information only and meets the conditions of 21 CFR 200.200); for bulk-sale and prescription-compounding ads, confirm the ad contains no claims for therapeutic safety or effectiveness of the drug. If no exemption applies and the ad is non-broadcast, confirm a true brief summary of side effects, contraindications, and effectiveness is present and accurately reflects required, approved, or permitted labeling. If the ad is broadcast, confirm the major statement of major side effects and contraindications is present in the audio or audio-and-visual parts of the presentation, AND separately confirm either a brief summary of all necessary side effect and contraindication information is present or adequate provision is made for dissemination of the approved or permitted labeling (e.g., referral to a website, toll-free number, print piece, or other accessible source of full labeling). A violation exists if the major statement is missing regardless of any adequate-provision referral, or if neither the brief summary nor adequate provision is present.

Escalate when

Escalate when it is unclear whether the exemption in (e)(2) applies (e.g., borderline reminder-ad content, or whether price-only content genuinely meets the §200.200 conditions), whether a broadcast ad's referral mechanism constitutes 'adequate provision' sufficient to excuse the brief summary under (B), or whether the brief summary or major statement content is a truthful, complete, and non-misleading restatement of the drug's side effects, contraindications, and (for non-broadcast ads) effectiveness information as reflected in required, approved, or permitted labeling.