Some drugs that improve price competition fall through the cracks of FDA user fees

This price competition relies on a determination by FDA that generic products are therapeutically equivalent to a brand name drug. That determination enables the generic drug to be automatically substituted at the pharmacy counter for the brand-name product. This in turn allows lower priced generics to quickly take market share from the more expensive brand. Therapeutic equivalence rating also unlocks competition for physician-administered drugs: drugs rated as such are combined into a single Medicare reimbursement code with the branded version,...