Generic Substitution Laws and Combination Products

Amirala S. Pasha


Generic substitution laws have greatly expanded the market share of generic drugs by allowing seamless substitution of cheaper generic drugs for more expensive pioneer drugs. These are state laws that provide a legal mechanism for a pharmacist to dispense a substitute drug deemed equivalent to the prescribed drug. However, with the proliferation of combination products, significant flaws in these laws have become apparent in recent years. Particularly, their more traditional approach to equivalency determination is inadequate in allowing appropriate substitution for a subset of combination products. A multi-pronged approach at the federal, state, and prescriber level is needed to address these limitations.