Work Group on Short-Term Drug Importation

In a break from past practices, FDA commissioner Scott Gottlieb says he is forming a work group to explore policy frameworks that could lead to short-term importation of drugs to help resolve specific drug shortage situations. In a statement, Gottlieb says the group will “consider whether and how the foreign versions of these medicines can be imported with adequate assurances of safety and effectiveness.” The group will focus on instances of supply chain dislocations or sudden, significant price increases that close channels of availability, leaving patients without access to drugs they need.

The statement says that among other things the work group will consider: 

•          statutory and regulatory requirements relevant to developing and advancing such a policy;
•          how FDA will define an access dislocation in these circumstances;
•          how FDA and HHS 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 FDA will ensure it continues to protect patient safety through a secure drug supply chain and pursue enforcement against unsafe and illegal drug products;
•          how to ensure that such a policy maintains the incentives and balanced framework that supports manufacturers seeking FDA approval for these products; and
•          what additional steps should be taken by FDA to continue to promote competition from additional FDA-approved versions of sole-source generic drugs, to be sure there is a U.S. supply of the medically-necessary medicines that is sustainable for the long run.

“Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories,” Gottlieb says. “Furthermore, any resulting policy would also be narrowly tailored in order not to create the same risks of counterfeits or other unsafe drugs getting into the U.S. supply chain as a broader importation policy would present. Our ultimate goal is to seek multiple FDA-approved and marketed versions of each medically important drug for which there are no blocking patents or other exclusivities.”