ALCON Rx NAPHCON-A MUST COME OFF MARKET, JUDGE TELLS FDA

ALCON Rx NAPHCON-A MUST COME OFF MARKET, JUDGE TELLS FDA in a Nov. 10 order for permanent injunction in a case brought by Allergan. D.C. federal court Judge Harold Greene ruled that FDA must "take the action necessary to ensure that Alcon Laboratories, Inc. removes the prescription version of its product Naphcon-A from the market until FDA has approved a New Drug Application for the product."

Allergan brought the suit (Allergan v. Shalala) seeking to force FDA to enforce a June 11, 1993 warning letter sent to Alcon, Allergan and 19 other firms that market ophthalmic products containing naphazoline and/or antazoline. The products had been marketed under FDA's Drug Efficacy Study Implementation program. In response to the FDA letter, Alcon declared that it intended to continue marketing of Naphcon-A during FDA's review of its pending NDA for the naphazoline .025%/pheniramine .3% product ("The Pink Sheet" June 21, 1993, T&G-5).

In its June 6 complaint against the agency, Allergan notes that it withdrew its naphazoline products (Albalon-A and Prefrin- A) upon receipt of the FDA letter. Allergan maintained that "FDA, through its acquiescence in the illegal marketing of Alcon's Naphcon-A product, is causing irreparable injury to Allergan due to lost sales of its legitimately marketed" ophthalmic anti- inflammatory Acular (ketorolac tromethamine).

The case is complicated by the June 8 approval of Naphcon-A for OTC use. FDA maintained that the approval mooted Allergan's complaint.

Naphcon-A was approved for OTC use the same day as Bausch & Lomb's naphazoline .027%/pheniramine .315% combination Opcon-A ("The Pink Sheet" Aug. 1, T&G-9). Alcon submitted its NDA (20-226) for the product on Oct. 10, 1991. "Naphcon-A is now an approved drug," the Justice Department Office of Consumer Litigation told the court. "Thus the relief Allergan seeks is not available... [because] the request is now moot." The government further maintained that FDA "had the authority to decline to pursue the matter as an exercise of its enforcement discretion."

Allergan, through its D.C. attorneys, Kleinfeld, Kaplan & Becker, maintained that the case was not moot. "Whereas prescription Naphcon-A is marketed for 'relief of ocular irritation and/or congestion or for the treatment of allergic or inflammatory ocular conditions,' OTC Naphcon-A is limited to use for 'the temporary relief of redness and itching of the eye due to pollen and animal hair.' Because of these different indications for use, the prescription and OTC version of Naphcon-A essentially are two different drug products for regulatory purposes." Allergan submitted an invoice for Naphcon-A that the firm maintained showed Alcon was continuing to market the prescription product after approval of the OTC version.

"The OTC and prescription versions of Naphcon-A are not purchased for the same purposes and thus are not the same product," Judge Greene ruled. "Since Alcon continues to market its unapproved prescription product without FDA interference while Allergan may not do so, the controversy cannot be regarded as moot."

The D.C. federal court further ruled that FDA's enforcement discretion in the case was limited because "FDA has commenced enforcement proceedings" by issuing the warning letters. "Thus, before the court is not an agency's refusal to take enforcement action, but rather an agency's refusal to continue or complete such an action, and indeed to proceed against some but not other similarly situated entities."