Table 3. Top 3 FDA guideline items to which advertisements were non-adherent and top 3 FDA guideline items to which advertisements were possibly non-adherenta.
| FDA Guideline Item | Non-Adherent No. | Possibly Non-Adherent No. (%) | Combined No. (%) | Example |
| Most common non-adherent items | ||||
| “Contains literature references or quotations that are significantly more favorable to the drug than has been demonstrated by substantial evidence” | 10 (12.0) | 10 (12.0) | 20 (24.1) | An advertisement for a drug for leukemia did not mention data related to standard of care drugs which are available generically. |
| “Uses headline, subheadline, or pictoral or other graphic matter in a way that is misleading” | 8 (9.6) | 5 (6.0) | 13 (15.7) | An advertisement for a drug for advanced lung cancer depicts a healthy-looking man apparently windsurfing on the open sea |
| “Represents or suggests that drug dosages properly recommended for … certain classes of patients or disease(s) are safe and effective for … other classes of patients or diseases” | 8 (9.6) | 0 (0) | 8 (9.6) | An advertisement for a hypertension medication which is not recommended in guidelines as a first or second line agent claims to be first-line for patients likely to need more than 1 agent |
| Most common possibly non-adherent items | ||||
| “Uses literature, quotations, or references that purport to support (a) …claim but…do not support the claim or have relevance” | 4 (4.8) | 22 (26.5) | 26 (31.3) | An advertisement for a drug for hematologic malignancy contains efficacy claims citing data on file. The cited study is now published and had an inappropriate comparison group, so it does not truly support the efficacy claim. |
| “Presents information from a study in a way that implies that the study represents larger or more general experience with the drug than it actually does” | 1 (1.2) | 20 (24.1) | 21 (25.3) | Multiple advertisements were “possibly non-adherent” to this item because there were no verifiable references. |
| “Contains references…that misrepresent the effectiveness of a drug by failure to disclose…information…concerning concomitant therapy…(or) placebo effect” | 5 (6.0) | 17 (20.5) | 22 (26.5) | An advertisement for a medication for pulmonary hypertension has claims for which the supporting data was an open-label trial; thus results may be related to placebo effect. |
a
Other items had identical rates, so the item with the highest combined rate is displayed.