The FDA has established a Bad Ads program to review promotional materials from drug manufacturers. This includes TV, radio, sales aids, journal ads, patient brochures, drug websites, webinars, email alerts, and e-details. Since starting the program, the agency has uncovered thousands of violations.
About Bad Ads Program
The Bad Ad Program is an FDA-sponsored outreach program designed to educate health care professionals about the role they can play in helping the FDA ensure that prescription drug advertising and promotion is truthful and not misleading.
The program helps health care professionals who prescribe medications or otherwise make selection decisions about the use of prescription drugs for patients (including physicians, nurse practitioners, nurses, physician assistants, and pharmacists) to better understand what constitutes appropriate prescription drug promotion and advertising and how to report possible violations.
Common Bad Ads Program Violations
The most common violations that drug manufacturers perform are making claims that not are appropriately supported, misrepresent study data, overstate drug’s benefits, omit or downplay risk information, omit material facts about the drug, fail to present a fair balance of risk and benefit, and misbrand an investigational drug not approved by the FDA.
Diclegis Example
The manufacturers of Diclegis hired known social media influencer Kim Kardashian to promote the use of their morning sickness medication. However, the ad portrayed the drug as being completely safe to the unborn fetus, which is not the case. There is nothing in the study submitted to the FDA that shows the drug is completely safe to the baby.
The FDA cited the manufacturer of Diclegis, Duchesnay USA in 2013. The company’s ad lacked drug safety information required in any medium that speaks of the drug’s efficacy.
Common Occurrence
This is just one example of drug manufacturers actively deceiving the American public to push the false efficacy or boosted fake results of their medication. This boosts sales of the medication, yet hurts thousands of people who do not know the dangers. However, help is always available. The Michael Brady Lynch Firm represents thousands of people injured by dangerous drugs or devices. Contact us today for a free consultation.