October 15, 2001
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FDA issues warning letters for Lumigan

The manufacturer of the glaucoma medication received two letters from the FDA regarding promotional materials.

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WASHINGTON — On March 26, and again on June 8, Allergan was issued “notice of violation” letters by the Food and Drug Administration regarding the promotion of its glaucoma drug Lumigan (bimatoprost).

The March 26 warning to Allergan objected to a “Dear Doctor” letter used as promotional material for Lumigan. The promotional letter, dated March 19, from Scott M. Whitcup, MD, Allergan vice president for ophthalmology, therapeutic area, was found to be misleading by the Food and Drug Administration (FDA).

In particular the FDA warning stated that the promotional letter “lacks fair balance and is misleading because it minimizes important risk information contained in bolded warning in the approved product labeling for Lumigan.” The bolded warning concerns possible permanent changes to pigmented eye tissues, such as increased pigmentation of the iris and periorbital tissue, and increased pigmentation and growth of eyelashes.

The FDA said the letter failed to present this information with prominence and readability comparable to the effectiveness claims. The FDA pointed out that the effectiveness of the drug is talked about in the body of the letter, while the warning is presented in the small print at the end of the letter, after the signature and enclosure reference.

In the same notice of violation letter, the FDA said it was also troubled by the claim that Lumigan is superior to timolol 0.5% dosed twice daily in clinical trials. The letter stated that the claim was misleading because Allergan was comparing the effectiveness of two products with dissimilar indications. “Timolol is indicated as a first-line therapy whereas Lumigan is indicated as a second-line therapy,” the letter stated. The comparison implies Lumigan is indicated as a first-line therapy, an unapproved indication, the letter stated.

The FDA noted that it had already informed Allergan of this in a March 15 letter.

In the March 26 letter, the FDA also warned Allergan of the violative nature of its claim of efficacy in the promotional material. In its Dear Doctor letter, Allergan stated that patients reached target intraocular pressures (IOPs) of less than 17 mm Hg and 15 mm Hg. The FDA pointed out that the product information for Lumigan states that patients in the clinical trials had a baseline IOP of 26 mm Hg, and that the IOP-lowering effect of Lumigan was 7 mm Hg to 8 mm Hg. That would indicate, they said, that the mean IOP achieved in clinical trials was 18 mm Hg to 19 mm Hg, which would be inconsistent with the claims in the letter, the FDA stated.

In a response to this letter, Allergan stated that it has attempted to show the FDA that the company’s claims were justified. Suki Shattuck, a spokeswoman for Allergan, said that during the clinical trials 65% of patients were shown to have an IOP less that 18 mm Hg. As yet, the FDA has not responded to this information, Ms. Shattuck said.

June letter

In a letter dated June 8, the FDA again warned Allergan of misleading promotional materials regarding its one-page advertisement with the heading, “Superior mean IOP achieved regardless of race.” The FDA pointed out that the ad lacked fair balance because it did not present any information relating to the product’s side effects, contraindications or risk.

The FDA said it was troubled that Allergan failed to provide any risk information, considering the fact that the approved product labeling for Lumigan includes a bolded warning.

The FDA also noted the claim in the advertisement that Lumigan “[a]chieve[s] low target pressure in more patients.” This claim is presented in conjunction with a comparative table that includes Lumigan, latanoprost and travoprost. The table presents IOP values for each drug in black patients and in non-black patients, in a manner that suggests that Lumigan is superior to latanoprost and travoprost in both populations.

The FDA said that the graph suggests that Lumigan has been studied in head-to-head trials with latanoprost and travoprost, which it has not, according to the FDA. The ad was found to be misleading because it suggests that Lumigan is superior to latanoprost and travoprost when it has not been demonstrated with substantial evidence, the FDA letter said. The FDA letter noted that Allergan placed a disclaimer in small type under the graph, saying the data was taken from separate comparable studies and not head-to-head, but they found the disclaimer to be insufficient.

Lastly, the FDA letter accused Allergan of overstating Lumigan’s efficacy, as in the earlier letter.

The warning letters to Allergan came from Warren Rumble of the FDA’s Division of Drug Marketing, Advertising, and Communications.

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