Not All Are Happy with FDA’s Final Guidance on NCE Exclusivity for Combination Products!

Today, FDA published its final guidance on New Chemical Entity (NCE) Exclusivity Determinations for Certain Fixed-Combination Drug Products (here). The Guidance comes about 7.5 months after the February 2014 Federal Register notice first announcing the new Agency position was published.  The Agency carefully considered the comments to its draft proposal before finalizing the Guidance today.

While some parties are happy with the decision to award NCE exclusivity if one of the components is a first time approval (the previous Agency position was that if one component had been previously approved, then the combination was not eligible for the 5-year protection), others are crying in their soup (and in Federal Court) about the change.  Why are some unhappy with the Agency’s new positon?  Because, “FDA intends to apply the new interpretation from the date of this guidance’s publication [and] [T]herefore, the new interpretation will not apply to fixed-combination drug products that were approved prior to the publication of this guidance document.”   This has some manufacturers crying foul.

The rationale for this change is explained as follows:  “The Agency recognizes that fixed-combinations have become increasingly prevalent in certain therapeutic areas (including cancer, cardiovascular, and infectious disease) and that these products play an important role in optimizing adherence to dosing regimens and improving patient outcomes. As further discussed below, we are therefore revising our historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.”  FDA further goes on to say, “We have 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 Guidance goes on to provide the historical basis for its previous decisions and the basis for its new interpretation in some detail and cites back to several petitions submitted in 2013 outlining the rationale for why the FDA should reconsider its position.

For those whose applications for combination products were denied the 5 year NCE exclusivity, the timing was just bad.  Will the courts be brought in to look at the fairness of the cutoff date for implementation of the new policy, or will the firms negatively impacted by the cutoff date just go about their business quietly?  One can quickly see some of the problems associated with making the new rule retroactive, as submissions of an ANDA would have been precluded for some of the previously approved combinations under the new policy where they were not under the old policy. How would FDA rectify that issue without causing disruption to the marketplace and the FDA review and approval process?  Talk about complex!  I think the Agency’s head would explode trying to figure out how to deal with individual cases, so the cutoff date seems to make perfect sense to me!  If you have further questions on this Guidance document please contact Joan Janulis at

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