Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities
As part of our public health mission, the Food and Drug Administration monitors the pharmaceutical supply chain to support patient access to medically necessary drugs. For example, as required by statute, the FDA maintains a publicly available list of drugs that are determined to be in shortage. We work closely with manufacturers and others to support patient access to these drugs while they’re in shortage.
We know, however, that for certain critical medicines, where there are no blocking patents or exclusivities associated with the drugs, but where there is only a single manufacturer (sole-source); conditions may develop that create significant barriers to, and ultimately threaten, patient access.
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