BIO Comments on Draft Guidance for Industry on New Chemical Entity Determinations for Certain Fixed-Combination Drug Products
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BIO supports FDA’s proposed revised interpretation in the Draft Guidance of the term “drug” in the eligibility clause of the New Chemical Entity (NCE) exclusivity statutory provisions. ” FDA’s revised interpretation, as expressed in the Draft Guidance, is a permissible reinterpretation, and when implemented, will positively impact public health, by encouraging innovation in fixed dose combination drugs. In order to both benefit public health as well as to ensure fair and consistent treatment of fixed dose combination product exclusivity determinations going forward, BIO urges FDA to finalize and implement this new interpretation expeditiously.</div>
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry: New Chemical Entity Determinations for Certain Fixed-Combination Drug Products (Draft Guidance).
BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative
healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
BIO supports FDA’s proposed revised interpretation in the Draft Guidance of the term “drug” in the eligibility clause of the New Chemical Entity (NCE) exclusivity statutory provisions. ” FDA’s revised interpretation, as expressed in the Draft Guidance, is a permissible reinterpretation, and when implemented, will positively impact public health, by encouraging innovation in fixed dose
combination drugs. In order to both benefit public health as well as to ensure fair and consistent treatment of fixed dose combination product exclusivity determinations going forward, BIO urges FDA to finalize and implement this new interpretation expeditiously.
Background
As explained in the Draft Guidance, under FDA’s historical interpretation of the term “drug” in provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act), the presence of a previously approved active moiety in a fixed combination drug product rendered the drug product ineligible for five-year NCE exclusivity. Specifically, FDA previously interpreted the term “drug” in the relevant statute to mean “drug product” rather than “drug substance.” Thus, in FDA’s view, all of the ingredients in the drug product were required to be eligible for five-year NCE exclusivity in order for the entire combination drug product to receive five-year NCE exclusivity. In other words, the combination drug was not eligible for five-year NCE exclusivity if it contained one previously approved active moiety, even if it also contained a previously unapproved NCE.
In 2013, FDA received three citizen’s petitions requesting the Agency revise its current interpretation of the five-year NCE exclusivity provisions with respect to certain fixed dose combination drugs. The various petitioners requested that FDA recognize five-year exclusivity under sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) of the FD&C Act for the combination drugs containing new active ingredients (that had not been previously approved) combined with a previously approved active ingredient. In general, the various petitioners argued that FDA’s interpretation of the relevant provisions of the FD&C Act were out of date, and had not kept pace with the important advances in medicine demonstrated by combination therapies. Petitioners also explained that FDA’s historic interpretation discourages the development of new fixed combination drug products with at least one previously approved active moiety. Simultaneous
with the publication of this Draft Guidance, FDA rejected all three petitions.
If the Draft Guidance is finalized, FDA would adopt the interpretation urged by the various petitioners. A five-year NCE exclusivity determination will be made for each “drug substance” or active ingredient within a combination drug product. As a result, an application for a fixed combination drug submitted under section 505(b) of the FD&C Act will be eligible for five-year NCE exclusivity if it contains a drug substance, no active moiety of which has been approved in any other application under section 505(b). For example, a fixed combination drug product that contains a drug substance with a single, new active moiety would be eligible for five-year NCE exclusivity, even if the fixed-combination drug also contains a previously approved active ingredient. Accordingly, in this Draft Guidance, FDA is proposing to revise its interpretation, and grant five-year exclusivity for certain fixed-combination drug products that contain both newly
applied and previously approved chemical entities.
