A Walk Among the SBAs: Waxing Poetic on a Bygone Era, the Development of the Exclusivity Summary, and the Need for Change

By Kurt R. Karst –      

As the years go by and nostalgia creeps in, we reminisce about the past and how things were “back then” (which to this blogger means the 1980s and 1990s).  It’s not that things were necessarily better “back then,” they were just different.  Take a gander at the National Geographic Channel’s “The ‘80s: The Decade That Made Us” or “The ‘90s: The Last Great Decade?” as this blogger did this past weekend and you quickly get a sense of what we mean. Nostalgia and reminiscence will envelope you.  We’re not advocating a return to an era of big hair, shoulder pads, leg warmers and when David Hasselhoff ruled the airwaves, but there’s something heartwarming – something quaint – about those simpler times. 

As a food and drug attorney, I have plenty of opportunities to indulge in the past.  Take, for example, FDA Summary Basis of Approvals (“SBAs”).  (An SBA is defined in an FDA regulation as a “document that contains a summary of the safety and effectiveness data and information evaluated by FDA during the drug approval process;” however, the term is often used to refer more generally to what is known today as a “Drug Approval Package” or an “Action Package” (see FDA MAPP 4520.1).)  We recently had a reason to look over some old SBAs.  Maybe it’s the old typeface (from an old word processor), the magic marker redactions, the cut-and-paste data tables, the unreadable (and unsearchable) pages of text (stamped with “BEST POSSIBLE COPY”), the hand written notes (and signatures), or the hand-drawn and oddly artistic lettering of the cover pages separating each SBA section in many SBAs (see below), but there’s some level of comfort in seeing these things – particularly when compared to the regimented SBA structure and rules in place today. 

One SBA component to which this blogger has always paid close attention is the “Exclusivity Summary” (also sometimes referred to as the “Exclusivity Checklist”).  The earliest version of that document we have seen dates back to a July 1990 revision, but was apparently developed in the 1980s according to a recent FDA response to a series of Citizen Petitions (see here at page 7).  Since then, the document, known generically as “Form OGD-011347,” and which we understand was a sort of homemade piece, has evolved with technology, but only rarely with changes in the law.  (At one time, there was an html version of the document titled “Exclusivity Checklist” that was completed by FDA.)       

The one clear constant with the “Exclusivity Summary” are the three component parts, which are intended to track and simplify changes made to the law by the 1984 Hatch-Waxman Amendments:

PART I – IS AN EXCLUSIVITY DETERMINATION NEEDED?

PART II – FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES

PART III – THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS

Changes in the law and the need for greater granularity have resulted in small changes and updates to the “Exclusivity Summary.”  For example, the following question appeared in Part I as late as August 2000: “e) Has pediatric exclusivity been granted for this Active Moiety?”  Later, FDA added the following clarification after that question: “If the answer to the above question in YES, is this approval a result of the studies submitted in response to the Pediatric Written Request?”  (Emphasis in original.)

The text of Parts II and III of the “Exclusivity Summary” in place today is virtually identical to the text in place in 1990.  This is so notwithstanding significant changes in the law adding new types of exclusivity (e.g., GAIN Act exclusivity) or clarifying how exclusivity can be applied under certain circumstances (e.g., enantiomers of previously approved racemates), and an evolution in FDA’s interpretation of the law.  The current “Exclusivity Summary” (see here at pdf pages 23-30) takes none of this into account, leaving questions unanswered, or the need to add comments.  Take, for example, combination drug products.  FDA’s recent reinterpretation of the law (see our previous post here) provides that NCE exclusivity is now available for newly-approved combination drugs containing an NCE and a previously approved drug.  Despite this, the current “Exclusivity Summary” includes the same questions in place when FDA interpreted the law to preclude an award of NCE exclusivity for certain combination drugs containing an NCE:

2. Combination product.

If the product contains more than one active moiety (as defined in Part II, #1), has FDA previously approved an application under section 505 containing any one of the active moieties in the drug product? If, for example, the combination contains one never-before-approved active moiety and one previously approved active moiety, answer “yes.”  (An active moiety that is marketed under an OTC monograph, but that was never approved under an NDA, is considered not previously approved.)

                                                                                      YES /_/  NO /_/

If “yes,” identify the approved drug product(s) containing the active moiety, and, if known, the NDA #(s).

IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS “NO,” GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should only be answered “NO” for original approvals of new molecular entities.) IF “YES” GO TO PART III.

In at least one instance, this required a FDA reviewer to clarify the award of NCE exclusivity:

NDA 205718 contains netupitant, a new chemical entity, in combination with palonosetron, a previously approved active moiety. Under the Agency’s new interpretation described in the Agency’s Guidance for Industry, New Chemical Entity Exclusivity for Certain Fixed-Combination Drug Products, a drug substance is eligible for 5-year exclusivity, provided it meets the regulatory definition of new chemical entity, regardless of whether that drug substance is approved in a single-ingredient drug product or in a fixed-combination with another drug substance that contains no previously approved active moiety, or in a fixed-combination with another drug substance that contains a previously approved active moiety. This NDA is thus eligible for 5-year new chemical entity exclusivity pursuant to the new interpretation.

Though quaint, the current version of the “Exclusivity Summary” is, like shoulder pads and big hair, outdated.  It needs a serious makeover to make the document useful.  At the very least, a revised “Exclusivity Summary” should include questions or information on all non-patent exclusivities available under the FDC Act.  For example, it should identify whether orphan drug designation and exclusivity was granted (and, in cases of clinical superiority, the basis for such a decision).  And in the case of generic drugs, it should identify whether 180-day exclusivity was granted or eligibility for such exclusivity forfeited. 

Why the “Exclusivity Summary” has gone without a makeover for so long while other important FDA forms, such as the Agency’s “RPM Filing Review” and associated “505(b)(2) Assessment,” have been revised significantly is unclear.  Until a significant change is made, the “Exclusivity Summary” is really just a relic of a bygone era – a reminder of the days when Hatch-Waxman was more simple.