Allergan asks FDA to reclassify Restasis

Allergan has filed a citizen petition with the Food and Drug Administration, requesting the agency remove cyclosporine from a list of proposed antibiotics that are ineligible for marketing exclusivity and patent listing. If that is not acceptable to the FDA, Allergan is requesting Restasis, its cyclosporine ophthalmic drug for keratoconjunctivitis sicca, to be reclassified as a non-antibiotic medicine.

According to paperwork filed with the FDA earlier this month, Allergan claims FDA improperly classified Restasis as an antibiotic drug in March, 3 months after granting approval of the drug and classifying it as a non-antibiotic. Allergan believes the FDA erred when, “after having already approved Restasis as … a non-antibiotic drug on Dec. 23, 2002, after many years of treating Restasis as an immunosuppressive drug for purposes of approval, FDA unexpectedly changed course and reclassified it as … an antibiotic drug on Mar. 3, 2003, making it ineligible for Hatch-Waxman benefits under FDA’s enforcement of its proposed rule,” Allergan noted in its petition.

The issue centers on marketing exclusivity — drugs classified under Hatch-Waxman are entitled to 30 months of patent exclusivity on new drugs and to have their patents listed in the Orange Book. Allergan claims that with $47 million already invested in the development of Restasis, reclassifying the drug in the manner the FDA has will cause irreparable monetary damage to Allergan.

A recent court case enjoined FDA from approving a generic version of Periostat (doxycycline) because the concentration of the active ingredient authorized did not have the capacity to inhibit or kill microorganisms as required of an antibiotic. Allergan claims the same situation; at the 0.05% concentration cyclosporine has been approved in Restasis, the drug is incapable of inhibiting or killing microorganisms, the petition states.