Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of 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, but no blocking patents or exclusivities

SILVER SPRING, Md., July 19, 2018 /PRNewswire/ -- 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. For example, as required by statute, the FDA maintains a publicly available list of drugs that are determined to be in shortage. We work closely with manufacturers and others to support patient access to these drugs while they're in shortage.

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.

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.

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 efforts, and help meet near-term patient need in the U.S. until new competition is able to enter the domestic market.

To pursue these considerations, we're forming a work group to explore various policy frameworks that, through the exercise of enforcement discretion or otherwise, 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. We 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, 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 involves the importation of drugs would be temporary until adequate competition enters these categories. 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. The agency has advanced a number of new initiatives, as part of our Drug Competition Action Plan, to pursue this primary and overriding objective of stable, safe and effective competition. The FDA approval process provides the highest global assurance of safety and efficacy. We'll continue to promote policies that advance incentives for seeking FDA approved versions of these medically necessary drugs.

Americans greatly benefit from our vibrant, competitive market for medicines. Patients shouldn't face inordinate challenges in getting necessary access to needed drugs. The FDA's mission is to support the long-term availability of safe and effective versions of medically important medicines. The goal of this work group is to balance these complementary objectives with a policy that facilitates near term access, while safeguarding the incentives that support a safe, stable and high-quality drug supply over the long term.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration