FDA creates work group to develop drug importation policy options
The Food and Drug Administration is exploring situations that might require short-term importation of drugs that could be hard to come by if the supply chain is disrupted or price hikes affect their accessibility. The agency has created a work group that will examine policy frameworks under which it would need to import foreign equivalents of FDA-approved drugs.
“We know, 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,” said FDA’s commissioner Scott Gottlieb. “Such conditions could include dislocations in the supply chain or sudden, significant price increases that close off channels of availability. These circumstances can leave patients without access to drugs they need. These could be situations where there’s only one U.S. approved and marketed version of an old drug that’s not commonly used, but is still medically important. Many of these cases involve generic medicines. These disruptions can create public health consequences that are similar to the occurrence of a drug shortage.”
"The FDA wants to examine whether — under these narrow conditions — the additional market competition from the short-term importation of foreign versions of the drug may complement the FDA’s current efforts, and help meet near-term patient need in the United States until new competition is able to enter the domestic market," Gottlieb said.
The work group is being asked to consider, among other things:
“We know, 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,” said FDA’s commissioner Scott Gottlieb. “Such conditions could include dislocations in the supply chain or sudden, significant price increases that close off channels of availability. These circumstances can leave patients without access to drugs they need. These could be situations where there’s only one U.S. approved and marketed version of an old drug that’s not commonly used, but is still medically important. Many of these cases involve generic medicines. These disruptions can create public health consequences that are similar to the occurrence of a drug shortage.”
"The FDA wants to examine whether — under these narrow conditions — the additional market competition from the short-term importation of foreign versions of the drug may complement the FDA’s current efforts, and help meet near-term patient need in the United States until new competition is able to enter the domestic market," Gottlieb said.
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.