As Prescribed

In an apparent effort to combat prescription drug shortages and price spikes, the US Department of Health and Human Services (HHS) recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI). This announcement essentially walks back FDA’s enforcement approach regarding “marketed unapproved drugs,” allowing them to continue to be sold consistent with the 2006 FDA policy, and may cause objections from those companies that spent millions of dollars in scientific resources and application user fees to obtain New Drug Application (NDA) approval for these drugs over the last 14 years.