Under the Food, Drug and Cosmetic Act (FD&C Act), the Agency grants five years of exclusivity – a period during which it will not approve a generic of the drug – for an approved new chemical entity (NCE). FDA grants three years of exclusivity for the approval of an already approved drug for a new indication or dosage. Historically, FCDs which consist of both a NCE and a previously approved drug were not eligible for five-year NCE exclusivity because one drug in the combination was already approved; these products received three-year exclusivity. Three filed Citizen Petitions arguing that these FCDs should be eligible for five years of exclusivity.

In the new draft guidance, FDA reversed its previous policy to allow these combination products (NCE + previously approved drug) to receive the five-year exclusivity because these combinations are viewed as drug substances (and thus “new”) rather than drug products. The Agency also denied the three Citizen Petitions, noting that this policy is only applicable for FCDs moving forward, and does not apply to previously approved FCDs.

According to FDA, this change in policy is intended to further incentivize innovation in the development of these FCDs, recognizing that these drugs are increasingly being used to treat a wide variety of complex therapeutic areas.

FDA is accepting comments for on this draft guidance until April 25.

To view FDA’s full draft guidance, click here.