Dramatic growth in the use of generic drugs has generated substantial savings for American consumers. To examine how the Department of Health and Human Services (HHS) can encourage the use of generic drugs, the Assistant Secretary for Planning and Evaluation (ASPE) examined barriers to, and opportunities for, expanding the use of generic drugs.
Unlike most conventional drugs, biological products are usually large, complex molecules that are produced by living organisms. These commercially engineered biologics currently account for billions of dollars in health care spending. Starting early last century, Congress has regulated most biologics separately from small molecules under the Bio