Wednesday, June 25, 2003

FEDERAL REGULATORS WARN THREE DRUG COMPANIES ABOUT ADVERTISING DEEMED MISLEADING, INACCURATE

The Food and Drug Administration issued warnings to three drug companies regarding their advertising practices.   In a letter sent to Johnson & Johnson and on the agency's Web site, the FDA stated that J&J's advertisements for its anemia pharmaceutical brand Procrit (epoetin alfa) are misleading and contain inaccurate clinical trial data.   The FDA said that advertisements for a J&J cancer management handbook are misleading because they imply that chemotherapy patients who receive Procrit can get their hemoglobin levels back to normal. Furthermore, the promotional material suggests that Procrit is more effective than has been shown by substantial evidence or clinical experience, the FDA letter said.   The FDA asked J&J to pull ads and promotional materials containing the disputed claims and to respond to its letter within 10 days.   The FDA also asked GlaxoSmithKline Plc to shelve radio and print advertisements for its Flonase (fluticasone propionate) prescription nasal allergy spray because it deemed these advertisements to be misleading.   The agency said that the advertisements indicate that Flonase can be substituted for the prescription allergy drugs Allegra (fexofenadine, Aventis SA), Clarinex (desloratadine, Schering-Plough Corp.) and Zyrtec (cetirizine, Pfizer Inc.). The FDA added that any such suggestion would be a violation since Flonase is not approved for as many allergy symptoms as the other three drugs. Allegra, Clarinex and Zyrtec are oral antihistamines approved for a range of symptoms, such as itchy and watery eyes, while Flonase is a corticosteroid approved only for nasal symptoms associated with seasonal allergies.   The FDA added that Flonase has not been demonstrated to be safe and effective in treating any of the non-nasal symptoms and that it is not therapeutically equivalent to the antihistamine products.   The agency said that GSK should submit a written response on or before July 3, detailing its intent and plans to comply.   Lastly, the FDA told Novartis Ophthalmics Inc., the eye-care-related unit of Novartis AG, that advertisements for its Zaditor eye wash (ketotifen fumarate 0.025 percent) are illegal because they exaggerate the effectiveness of the drug.   The agency asked Novartis to pull its television advertisements and take down a Zaditor Web site because they claim that the eye wash works better than other eye drops or pill-based allergy drugs, despite a lack of evidence. In a letter to the company, the FDA also said that the advertisements omit or downplay possible side effects and other risk-related information.   The FDA asked Novartis Ophthalmics to immediately discontinue all advertising for the drug and to submit a written response by July 2.