Should the FDA’s Unapproved Drug Initiative Be Terminated?
The Department of Health and Human Services (HHS) is taking steps to end the US Food and Drug Administration’s (FDA) Unapproved Drug Initiative (UDI), which was launched in 2006 to encourage manufacturers to seek approval for older drugs that were on the market before FDA approval processes were in place. The Trump administration stated that the program has unintentionally allowed manufacturers to increase prices on older drugs, and has also led to drug shortages. However, once the UDI is removed, the FDA will not take the same action against unapproved drugs that it would have taken under the UDI.
HHS is ending the FDA’s Unapproved Drug Initiative, citing higher prices on older drugs and drug shortages. However, this means that heightened enforcement against unapproved drugs will end. Are you for or against ending the Unapproved Drug Initiative?
Last Answered: 6 days ago