Did the FDA Disregard a Good Solution for Drug Warnings?

“John Fratti, a 50-year-old former pharmaceutical sales representative was making plans to end his life because he could no longer stand the pain caused by Fluoroquinolone Toxicity.” This was the jolting opener to a recent article published in The Atlantic, “What Americans Don’t Know About Their Medications.” John might never have considered taking these drugs had he better understood the potential harm vs. the benefits.

Researchers had proposed a novel idea to the FDA for the creation of a Drug Facts Box that would act like a “nutrition label for prescription drugs.” The brainchild of Dartmouth professors Steven Woloshin and his late wife, Lisa M. Schwartz, the Drug Facts Box was envisioned as a one-page sheet that doctors would give to patients that could simplify and clarify the lengthy and sometimes confusing information that appears in consumer drug ads and medication guides that patients receive at the pharmacy.

Alas, the FDA opted not to move forward with the Drug Facts Box citing that “developing a useful, accurate box would be difficult for some prescription drugs.”