BE Guidances Flying Off the Shelf – The Revisions Can Hit the Floor the Hardest!

Today, the FDA issued twenty-two new bioequivalence recommendations, some of which were for some fairly old products, including a couple of DESI drugs.  There were no surprises in the newly issued listings; however, as we have gone on about previously, the FDA has also issued fifty-two – yes, fifty-two – revisions to previously issued guidances.  Sponsors can catch a glimpse of the new and revised guidance documents here and then revisit pending applications or approved applications and try to see what (if anything) you will need to do to ensure your product now meets the revised guidance recommendations.

This has been an ongoing problem, which is talked about in the industry on a routine basis, but there never seems to be a good solution to the moving target caused by the numerous revisions of these guidance documents.  In addition, repeat studies are inconsistent, with one of the objectives of Hatch‑Waxman, namely, to reduce unnecessary, duplicative human testing.  While it may sometimes be necessary to repeat BE studies when there is a good reason that could impact efficacy or substitutability, what have we learned from the retesting performed based on revised BE recommendations?  Has there been a real concern?  Have products tested failed the new recommendations but passed the old?  What is the track record and how has the FDA reacted, if at all, to the results?

These are important questions that need to be answered as they impact not only the time and money that sponsors must invest, but can significantly delay the availability of generic drugs’ entry into the marketplace.  This will also impact drug prices as the costs of the additional testing will likely be passed onto consumers.  Granted, there may be times when new BE studies are necessary, but shouldn’t the utility and benefit of such additional testing be worth a critical look?  This is especially relevant when the number of revisions is so significant.