The goal is to reduce drug prices by creating competition.
US Food and Drug Administration (FDA) is taking action to fulfill the agency’s mission of increasing competition and reducing drug prices. The move is in response to “dramatic price increases” on unchallenged, off-patent medications, according to Alex Azar Secretary of the U.S. Department of Health and Human Services (HHS).
FDA is putting together a working group that will consider opportunities for temporary drug importation to address drug shortages and to provide competition for drugs with monopoly pricing power. Broader proposals for drug importation have been voted down by the Republican Congress. However, this plan targets drugs for which patients have limited access due to shortages of supply or excessive costs.
Said Azar: “[I]mportation could help address price hikes and supply disruptions that are harming American patients. We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities.”
FDA previously compiled a list of off-patent drugs without competition. The working group will develop policies and procedures for allowing the temporary importation of drugs approved in other countries that can serve as competition or address shortages. Each drug will be imported only until a US drug is approved or the shortage is resolved. The group will need to answer questions such as how the agency will determine when imports should be allowed and whether they are safe.