On Tuesday, the Association of Accessible Medicines (AAM) heralded the passage of the Q1/Q2 bill as a mechanism to speed certain generic drugs through the FDA approval system by making information on the qualitative and quantitative formulation of certain products available to generic manufacturers seeking approval a generic version of those products. AAM’s announcement here said the “Q1/Q2 [legislation] will cut red tape, save the U.S. healthcare system over one billion dollars, and bring lower-cost medicines to patients sooner.” For years, we have seen fits and starts getting this legislation passed and now finally it has become part of the healthcare spending package recently enacted by congress.
We at the Lachman blog have been writing about this age-old issue for well over a decade with its origins dating back to the passage of the Hatch-Waxman of 1984. Please search the Lachman blog (here) using the term Q1/Q2 to find out what all of the hubbub was about. Now, with the passage of this landmark legislation, the FDA can provide critical information on the formulation of topical, parenteral, and other dosage forms where a similar qualitative and quantitative formulation may make a generic product eligible for an in vivo bioequivalence waiver which will reduce the regulatory burden by basing a finding of bioequivalence between the test and references products on physicochemical characterization rather than costly complex bioequivalence testing or bioequivalence studies with clinical endpoints.
Congratulations to AAM and all the organizations that have been untiringly pursing passage of this legislation! Now, it is time for implementation. Let’s get to work!
