WASHINGTON — The Food and Drug Administration is pursuing an aggressive enforcement strategy to protect the public, including the issuance of letters to drug manufacturers whose products, although not necessarily unsafe, are promoted through what the agency says are misleading ads.
Although the letters do not represent legal action, the FDA has sent correspondence in recent weeks regarding ads for such products as Botox, Procrit and Flonase.
For example, the agency claims recent print advertisements for l3otox are misleading and should be removed. In a letter to Allergan Inc., manufacturer of the wrinkle-smoothing drug, the FDA finds the ads falsely identify the biological product as a cosmetic treatment, fail to reveal significant facts concerning its use and minimize its risk.
Related Results
FlonaseFirst generic FlonaseGeneric forms of Flonase are available againJudge orders halt to sales of generic FlonaseFlonase ad fails review; slump coming for TV ads
Regulators also ruled that GlaxoSmithKline (GSK) should withdraw radio and print advertisements for Flonase. The FDA says the promotions suggest that the prescription nasal allergy spray can be substituted for such allergy medicines as Allegra, Clarinex or Zyrtec, adding that the GSK drug is not approved for as many allergy symptoms as the other three prescriptions.
Allegra, Clarinex and Zyrtec are oral antihistamines approved for a number of symptoms, including itchy eyes; Flonase, a corticosteroid, is cleared only for nasal symptoms associated with seasonal allergies.
The FDA letter to GSK points out that Flonase is neither therapeutically equivalent to the oral antihistamine nor interchangeable with or a substitute for them. The agency says Flonase has not been demonstrated to be safe and effective in treating any nonnasal symptom.
“GSK should immediately discontinue the radio and print ads and all other promotional materials and activities for Flonase that contain the same or similar violative presentations,” the FDA letters says.
Johnson & Johnson’s (J&J’s) Procrit ads are misleading, contain inaccurate clinical trial data and should be pulled, says the agency. The promotional material, it notes, implies that Procrit is more effective than has been shown by substantial evidence or clinical trial experience. J&J has a license from Amgen Inc., manufacturer of the bioengineered drug, to sell the product in the United States.
Aingen also sells Aranesp, a longer-lasting version of the red cell booster used by chemotherapy patients, putting the world’s No. 1 biotechnology company into direct competition with J&J/Procrit.
The government charges an ad campaign by Novartis Pharmaceuticals Inc. implies that Zelnorm, a drug for irritable bowel syndrome (IBS), works significantly better than it really does and that such advertising should be stopped. Although the ad doesn’t mention the drug by name, it discusses a “treatment from Novartis” that is “beating IBS.”
Separately, the FDA has notified Novartis Ophthalmics Inc. that its television broadcast ads for Zaditor are misleading because they make unsubstantiated superiority claims and other assertions that overstate the efficacy of the drug and minimize or omit risk information.
COPYRIGHT 2003 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning