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Just before Thanksgiving, the Food and Drug Administration's ("FDA's") Office of Prescription Drug Promotion ("OPDP") silently published three untitled letters, furthering this administration's promise to crack down on direct-to-consumer ("DTC") prescription drug advertising.1 The letters (which we'll call "Letter 1," "Letter 2," and "Letter 3") addressed familiar enforcement themes, such as omission or minimization of risk information, ad presentation and form, and promotion consistent with FDA-required labeling ("CFL"). The letters appeared to have been leftovers from the shutdown, dated from earlier in September when the crackdown was in full swing. This is why we refresh these pages daily.
- Letter 1
OPDP found a television ad for an oral cardiovascular medication misleading and, therefore, misbranded under the Food, Drug, and Cosmetics Act ("FDCA"), because it overstated the drug's approved indication. Specifically, the ad represented that the drug was approved on the single endpoint of "reducing the risk of cardiovascular death" in adults with chronic kidney disease ("CDK") or heart failure ("HF"); however, the drug's FDA-approved Prescribing Information indicates that approval was based on more granular composite endpoints, including reduction of sustained estimated glomerular filtration rate decline, progression to end-stage kidney disease, cardiovascular or renal death in CDK patients, and reduction of cardiovascular death, hospital visits, or urgent visits in HF patients. - Letter 2
OPDP found a webpage for a ketamine injection intended for surgical pain management misleading and, therefore, misbranded under the FDCA, because it promoted the benefits of the drug without communicating risk information and overstated the drug's approved indication. Specifically, the webpage promoted the drug for pain management in all surgical and diagnostic procedures, but failed to communicate important use limitations from the drug's FDA-approved Prescribing Information, including an exclusion for procedures requiring skeletal muscle relaxation and specifications that it be used before and/or as a supplement to other general anesthetic agents. OPDP found this especially concerning because this particular drug is a generic and the webpage misleadingly suggested that its intended use was broader than that of its reference listed drug. To wrap up its letter, OPDP also cited the company for failing to submit a copy of the webpage under a Form FDA-2253 prior to initial publication, as required by FDA regulations. - Letter 3
OPDP found a television ad for an oral seizure medication misleading and, therefore, misbranded under the FDCA, because it promoted the benefits of the drug with minimized presentation of risk information. Specifically, the ad (i) excluded a warning concerning the risk of liver injury from the drug's Prescribing Information; (ii) failed to disclose the risk of problems with the heart's electrical system, as included in the drug's FDA-approved labeling, despite the fact that the ad stated "[s]erious, life threatening allergic reactions or rash can occur, which may affect the liver, other organs, body parts, or blood cells, as can problems with the heart." Additionally, certain material information from the drug's major statement (i.e. the presentation of major risks required for all pharmaceutical television ads) was included in SUPERS but not in the corresponding audio, even though benefits were presented via SUPERS and audio.
Footnote
1. See our post on OPDP's previous enforcement under this administration.
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