FDA Forms Work Group to Develop Drug-Importation Policy OptionsBy
The US Food and Drug Administration (FDA) has formed 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 for which there are 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,” FDA Commissioner Scott Gottlieb said in a July 19, 2018 agency statement. “…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.”
These conditions Gottlieb refers to include dislocations in the supply chain and “sudden, significant” price increases that close off channels of availability. Many of these cases involve generic medicines, according to information from the FDA.
“We want 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 effort and help meet near-term patient need in the US until new competition is able to enter the domestic market,” Gottlieb explained in his statement.
To pursue these considerations, the FDA is forming a work group to explore various policy frameworks that would involve the importation of drugs under circumstances that meet these criteria and that would be suitable substitutes for the FDA-approved version of the medically necessary drugs. The agency says it will consider whether and how the foreign versions of these medicines can be imported with adequate assurances of safety and effectiveness.
The work group is being asked to consider items, including: the statutory and regulatory requirements relevant to developing and advancing such a policy; 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; and how the FDA will protect patient safety through a secure drug supply chain and pursue enforcement against unsafe and illegal drug products.
“Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories,” Gottlieb said in his statement. “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.”