The FDA is forming a work group to consider situations under which the FDA would allow the importation of drugs that would be suitable substitutes for the FDA-approved version of medically-necessary drugs. The initiative comes as a result of recognizing that in some situations access to older drugs that are not in wide use but may be medically necessary can be threatened by significant price increases or disruptions in supply chains.
The work group is being asked to consider, among other things:
Any policy that would allow the importation of would be temporary until adequate competition enters these categories. The statement also said that any policy implementation would be tailored to prevent the introduction of counterfeit drugs into the US supply chain.
The initiative is part of the FDA's Drug Competition Action Plan. Ultimately the agency is attempting to foster an environment of stable, safe and effective competition. Perhaps such a policy would deter those who would mimic Martin Shkreli and others who have raised prices astronomically on sole source drugs without any reasonable justification.