Physician Complaints Lead to FDA Trade Show ‘Policing’

Responding to complaints from physicians and competing drug companies, the FDA has "stepped up" its monitoring of drug advertising at medical conventions, recently citing "several companies" for allegedly making "improper statements or other presentations" about their drugs, the Wall Street Journal reports. FDA officials have recently recorded at least nine cases of improper statements made by representatives working at booths at conferences sponsored by groups such as the American Society of Clinical Oncology and the American Society of Heath-System Pharmacists. For example, GlaxoSmithKline was cited after a representative at the oncology group's annual meeting said that "patients using [the cancer treatment] Navelbine don't feel like they received chemotherapy." Noting that the drug's side effects include nausea, vomiting and hair loss, the FDA said the statement "misleadingly suggests that Navelbine has less serious side effects than has been demonstrated." Alza Corp. was also cited as the result of statements made by representatives at the oncology conference. Company representatives distributed hair brushes labeled "Doxil" as a promotional tool for the ovarian-cancer treatment, saying, "We are giving this to you because you don't lose your hair with Doxil." But the FDA says the claim is "false or misleading" because 15% of patients using the drug experience hair loss. Both companies said they are working with the FDA to "resolve" the situation, either by pulling or amending their sales pitches, the Journal reports. The FDA "normally monitors" drug advertising in the print or broadcast media, but Thomas Abrams, director of the FDA's division of drug marketing, advertising, and communications, said, "The more we looked into [conferences], the more we saw it was a problem." He added that "policing" conferences takes more time than monitoring drug ads. Abrams said, "I can write three letters on journal advertisements in the time it takes me to verify an oral presentation by a sales rep" (Adams, Wall Street Journal, 7/30).