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Comments on FDA's “Draft Guidance for Industry: New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products”




April 28, 2014




Division of Dockets Management

U.S. Food and Drug Administration

5630 Fishers Lane

Room 1061, HFA-305

Rockville, MD  20852



Docket No. FDA-2013-D-1675 – Comments on FDA’s “Draft Guidance for Industry:  New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products”

Dear Sir or Madam:

The Specialty Pharma Association (“SPA”) supports the U.S. Food and Drug Administration’s (“FDA’s” or “the Agency’s”) newly issued “Draft Guidance for Industry:  New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.”  The new statutory interpretation set forth in the Draft Guidance is the only correct reading of the exclusivity provisions of the Federal Food, Drug & Cosmetic Act, and is in the interests of public health. We disagree, however, with FDA’s decision to apply the new policy “prospectively,” pending public comment and finalization of the Draft Guidance. Public health and pharmaceutical innovation will be negatively impacted by this delayed application of good public policy. 

First, FDA’s approach here will create significant regulatory confusion. It is unclear from the language of the Draft Guidance whether, assuming FDA adopts the new interpretation at some undetermined future date, the new interpretation will apply to (1) drug applications that are already in the review queue, (2) that have been submitted but not yet accepted for filing, or (3) that have been submitted only after FDA’s adoption of the interpretation.  As such, a company submitting a new drug application for a fixed-combination drug product will not know whether its new drug will be eligible for three-year or five-year exclusivity at the time it submits the application to the Agency. Certainty in this realm is important, and for planning purposes companies need more clarity on this issue than has been provided. We believe that the most efficient and reasonable way to achieve the necessary clarity is for FDA to implement its new NCE exclusivity policy immediately, rather than at a later, “prospective” date.


Second, the Agency’s “prospective” approach will stifle the very new drug product innovation that it wishes to promote, in several ways. Under the “prospective” scheme, drug manufacturers now will have little incentive to develop fixed-combination drug products that include novel and previously-approved active moieties because there is no certainty whether five-year NCE exclusivity for such products will ever be available.  Drug manufacturers may also decide to place development of these products on hold pending finalization of the Exclusivity Draft Guidance.  Finally, FDA’s actions here create yet another disincentive – namely, that industry will be reticent to petition FDA in the future for important policy and statutory interpretation changes out of concern that they will not benefit from FDA’s decision. 

For the above stated reasons, SPA supports FDA’s decision to revise its historical interpretation of five-year NCE exclusivity so that a fixed-combination drug product containing a previously-approved active moiety can receive five-year NCE exclusivity; however, we do not agree with the Agency’s decision to postpone implementing this new statutory interpretation to some indeterminate point in the future.  It is in the interests of public health, policy, and fairness for FDA to implement its new and legally correct interpretation immediately.

Respectfully submitted,


Perry N. Cole


Specialty Pharma Association










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