FDA Forming Working Group on Imported Prescription Drugs to Address Price Spikes

The working group will examine importation of drugs that have seen significant price increases or significant access challenges for patients, and it will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer.

At the request of U.S. Health and Human Services Secretary Alex Azar, FDA Commissioner Scott Gottlieb is setting up a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities, the agency announced July 19.

"We look forward to working with Commissioner Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients," said Azar. "We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug Daraprim, we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000 percent. Safe, select avenues for importation could be one of the answers to these challenges. When HHS released the President's Blueprint for putting American patients first, I said we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access.

"Importation may well fit that bill in some instances. We look forward to working with Commissioner Gottlieb on this issue and appreciate the voluminous work FDA has done to increase competition in America's drug markets," he added.

The working group will examine importation of drugs that have seen significant price increases or significant access challenges for patients, and it will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer.

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    October 2020

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