Prescription Drugs Marketed in the United States Should Be Approved by the FDA

Prescription Drugs Marketed in the United States Should Be Approved by the FDA. Two events in the drug regulatory approval process in recent years warrant the attention of managed care pharmacists and should prompt reassessment of assumptions regarding drugs marketed in the United States. The first event, involving levothyroxine, received considerable public attention from 1999 through 2002. The second event involves an appellate court decision in May 1999 regarding combination product esterified estrogen and methyltestosterone (Estratest and Estratest HS, Solvay Pharmaceuticals). The circumstances of these events are noteworthy, and the social and market effects of each are sizable.