The rules underlying the assessment of quality of generic drugs, and their bioequivalence to brand name products, have not changed significantly since the passage of the Hatch-Waxman Act in 1984. Yet the products on the market are significantly more complicated today, which may imply that two...

In this paper, the authors document the complex issues facing the FDA in assessing the quality of generic drugs. They conclude that increased transparency as well as the updating of FDA bioequivalence standards may be important to overcome some of these challenges.

Evidence from numerous studies shows that emerging markets have far more poor quality drugs than western markets. There are many reasons for this, but one reason, investigated in this paper, is the possibility that smaller, often privately-owned, pharmacies take greater risks with drug...