October 21, 2014
On October 10, 2014, the U.S. Food and Drug Administration (FDA) issued a guidance document titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.” The document sets forth a change in the agency’s interpretation of the Federal Food, Drug, and Cosmetic Act provisions that relate to five-year new chemical entity (NCE) exclusivity, specifically as these provisions apply to certain fixed-combination drug products. Under the FDA’s revised interpretation of the NCE provisions, the FDA will allow new fixed-dose combination drugs that consist of at least one new drug product to be eligible for NCE exclusivity. Under the FDA’s previous interpretation, if one of the components of the fixed-combination had been previously approved, then the combination was not eligible for NCE exclusivity.
The FDA stated that its interpretation was based on several grounds, namely that fixed-combination drugs have become increasingly more important in treating cancer, cardiovascular, and infectious disease, and that fixed-combinations are important in optimizing adherence to dosing regimens and improving patient outcomes. For these reasons, the FDA stated it is “therefore revising [its] historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products,” and that it has “concluded that interpreting the applicable statutory and regulatory provisions to permit broader availability of 5-year NCE exclusivity for certain fixed-combinations would further incentivize the development of these important products.”
The FDA intends to apply this new interpretation from the publication date of this final guidance, and therefore the new interpretation will not apply retroactively.
For more information on the FDA’s new interpretation, please contact Fitch Even partners Christine Abuel Pompa or Kendrew H. Colton.
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