FDA to Consider Foreign Drug Importation When Lack of Competition or Supply Problems Threaten Access

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:

  • The statutory and regulatory requirements relevant to developing and advancing such a policy;
  • How the FDA will define an access dislocation in these circumstances;
  • How the FDA and the Department of Health and Human Services will evaluate the public health need for access to foreign-approved drugs in these situations;
  • How the agency will assess the safety, effectiveness and labeling of a foreign-approved drug that could be eligible for importation under such a policy;
  • How the FDA will ensure that we continue to protect patient safety through a secure drug supply chain and pursue enforcement against unsafe and illegal drug products;
  • How to ensure such a policy maintains the incentives and balanced framework that supports   manufacturers seeking FDA approval for these products, as this is our primary objective; and
  • What additional steps should be taken by the FDA to continue to promote competition from additional FDA-approved versions of these sole-source generic drugs, to make sure that we achieve a U.S. supply of these medically-necessary medicines that is sustainable for the long run.

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.