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POSTED BY COURTENAY C. BRINCKERHOFF ON 26 FEBRUARY 2014POSTED IN FDAIn a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a draft guidance for industry that will provide a 5 year NCE exclusivity period to fixed-combination drug products that include at least one new drug substance.

The Statute And Regulations At Issue

Sections 505(c)(3)(E)(ii) and (j)(5)(F)(ii) of the Food, Drug, and Cosmetic Act and 21 CFR § 314.108 provide for a 5 year period of regulatory exclusivity for drug products that include a new chemical entity (NCE).  In particular, 21 CFR § 314.108(b)(2) provides:

If a drug product that contains a new chemical entity was approved after September 24, 1984, in an application submitted under section 505(b) of the act, no person may submit a 505(b)(2) application or abbreviated new drug application under section 505(j) of the act for a drug product that contains the same active moiety as in the new chemical entity for a period of 5 years from the date of approval of the first approved new drug application, except that the 505(b)(2) application or abbreviated application may be submitted after 4 years if it contains a certification of patent invalidity or noninfringement described in 314.50(i)(1)(i)(A)(4 ) or 314.94(a)(12)(i)(A)(4 ).

21 CFR § 314.108(a) defines NCE as follows:

New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act.

With regard to fixed-combination products, the FDA has interpreted the statute and regulations as providing for a 5 year NCE exclusivity period only if all drug substances in the fixed-combination product are “new.” Under the new draft guidance, fixed-combination products could qualify for a 5 year NCE exclusivity period as long as any drug substance in the fixed-combination product is new.

Policy Concerns

According to the Federal Register Notice, the FDA is taking this action in order to further incentivize the development of fixed-combination products, that “have become increasingly prevalent in certain therapeutic areas” and that “play an important role in optimizing adherence to dosing regimens and improving patient outcomes.”

Draft Guidance

As explained in the Federal Register Notice, “a drug product would be eligible for 5-year NCE exclusivity provided that it contains any drug substance that contains no active moiety that has been previously approved.” If you can’t follow that sentence construction, the Notice explains further, “This will permit a drug substance that meets the definition of new chemical entity (i.e., it contains no previously approved active moiety) to be eligible for 5-year NCE exclusivity, even when it is approved in a fixed-combination with another drug substance that contains a previously approved active moiety.”

A Forward-Looking Change

The Federal Register Notice indicates that this change is prospective, and will apply “when finalized.”  Thus, currently approved fixed-combination products may not benefit from this new 5 year NCE exclusivity period.

Filling A Gap Left By The Patent System? 

The FDA’s goal of incentivizing the development of combination therapies stands in contrast to the patent perspective, where it is becoming increasingly difficult to obtain (or sustain) patents directed to combination products and therapies, which often are challenged as being “obvious.” While a 5 year period of regulatory exclusivity may not provide as much incentive as a 20 year patent term, it is interesting to see the FDA filling a gap that may be left by the current climate of the patent system.

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