02 August 2019
The U.S. Department of Health and Human Services (HHS) announced that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets.
“President Trump has been clear: for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices. When we released the President’s drug pricing blueprint – PDF for putting American patients first, we said we are open to all potential solutions to combat high drug prices that protect patient safety, are effective at delivering lower prices, and respect choice, innovation and access,” - said Health and Human Services Secretary Alex Azar.
“The announcement outlines the pathways the Administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients. This is the next important step in the Administration’s work to end foreign freeloading and put American patients first.”
The Action Plan outlines the government’s intention to pursue two pathways to allow safe drug importation from foreign markets:
“We support the President and Secretary’s efforts to bring down drug prices for Americans. The FDA has a unique role to play in promoting competition that in turn can help reduce drug prices and improve access to medicine for Americans,” - said Acting FDA Commissioner Ned Sharpless, M.D.
“Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge. Today’s proposal is the result of the hard work by the dedicated staff of the FDA, in close collaboration with HHS and the White House, to identify potential pathways we can pursue to support the safe importation of certain prescription drugs. We’ve been keenly focused on ensuring the importation approaches we’ve outlined pose no additional risk to the public’s health and safety. We know there are many operational challenges to address through each of these pathways, and are actively working through them as we look to formally announce these policies, with opportunity for public comment, in the coming months.”
President Trump and Secretary Azar continue to explore all ways to tackle the soaring price of prescription drugs while protecting incentives for innovation and maintaining standards of quality to promote patient safety and access to needed medicines. Today’s Action Plan outlining the Department’s proposal is a follow-up to work that HHS and FDA have done together to explore solutions to improving Americans’ access to lower-cost versions of drugs that have seen significant price increases or significant access challenges for patients. It reflects an ongoing effort by the Trump Administration to respond to the concerns of the American people and to encourage action by Congress to make healthcare more affordable.
The FDA has delivered historic levels of generic drug approvals during the Trump Administration, with the Council of Economic Advisors estimating the savings generated from generic approvals in the first 18 months of the Trump Administration to be $26 billion. The Trump Administration’s drug pricing plan has also delivered the biggest 12-month decrease in over 50 years of the prescription drug component of the Consumer Price Index, the official government measure of drug price inflation.
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