Everything we’ve been doing at HHS under President Trump is aimed at breaking down barriers and distortions, facilitating a market that lowers prices for American consumers. New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.
As Prepared for Delivery
Hello, everyone, and thank you for joining us.
President Trump has made lowering drug prices and increasing access to safe, effective, and affordable prescription drugs a top priority.
Today’s importation proposals are a historic step forward in efforts to bring down drug prices and out-of-pocket costs.
Everything we’ve been doing at HHS under President Trump is aimed at breaking down barriers and distortions, facilitating a market that lowers prices for American consumers.
New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.
We’re announcing two actions today. First, the FDA is issuing a notice of proposed rulemaking which, if finalized, would authorize states, potentially working with wholesalers or pharmacies, to develop programs that would allow importation of certain prescription drugs from Canada.
We appreciate the strong interest and leadership we’ve seen regarding this possibility from governors of both parties, including Governor DeSantis of Florida, Governor Mills of Maine, Governor Polis of Colorado, Governor Scott of Vermont, and Governor Sununu of New Hampshire.
Second, we are publishing a draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of their FDA-approved drugs, including biological products, into the U.S. when the drug is manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drug makers new flexibility to reduce prices.
These are both important steps in advancing the FDA’s Safe Importation Action Plan, which we announced this past summer. The Safe Importation Action Plan aims to ensure that importation is done in a way that prioritizes safety and includes elements to help ensure importation does not put patients or the U.S. drug supply chain at risk.
I want to repeat: we will not take steps that would put patients or our drug supply at risk.
There has been a longstanding debate about the role importation can play in a safe drug supply chain, and there have always been questions about how effective importation can be at lowering costs.
Supply chains and markets have changed over time. President Trump has been bold enough to recognize the opportunities we have on importation, and he’s delivering solutions.
Under President Trump, we have arrived at commonsense solutions that we believe can deliver results and keep patients safe. That is why, for the first time in history, HHS and FDA are open to importation as a means to lower drug prices.
We want to see proposals from states, potentially in conjunction with wholesalers and pharmacies, that can help accomplish our shared goal of access to safe and effective prescription drugs at lower prices.
HHS and FDA are advancing these two pathways as quickly as possible, and we look forward to hearing from stakeholders and the public.
We’ll continue to explore all avenues for lowering drug prices while protecting incentives for innovation and maintaining standards of safety, effectiveness, and quality.
We’re driving competition through historic levels of generic drug and biosimilar approvals, we’ve banned pharmacy gag clauses, and we’ve allowed Medicare Advantage plans to negotiate more effectively against drug companies.
Under President Trump, according to CMS data, retail prescription drug prices dropped in 2018 for the first time in more than 40 years, and prescription drug price inflation saw the biggest decrease in June in more than 50 years.
We are committed to producing more results, by introducing more competition, tougher negotiation, better incentives, and lower out-of-pocket costs throughout our drug pricing system
We look forward to ongoing work in these areas with Congress, and I look forward to announcing new efforts to put American patients first in the near future.
Thank you for joining us today. I now want to hand things over to HHS Assistant Secretary for Health Admiral Brett Giroir.