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Speech

Event Title
HHS Media Briefing on the Safe Importation Action Plan
July 31, 2019

Speech by
Norman E. "Ned" Sharpless, MD
Leadership Role
Acting Commissioner of Food and Drugs - Food and Drug Administration

Remarks Prepared for FDA Acting Commissioner Ned Sharpless, M.D.

As Prepared for HHS Media Briefing on the Safe Importation Action Plan July 31, 2019; 8:45 a.m. ET

Good morning. I’m Ned Sharpless, Acting Commissioner for the U.S. Food and Drug Administration. It’s a privilege and an honor to serve in this post and represent the FDA’s dedicated workforce around the globe, all working in their own unique ways to advance our mission to protect and promote the health of the American public.

As you may know, prior to joining the FDA, I served as director of the National Cancer Institute at NIH since 2017. Before that, I was a cancer researcher and cancer doctor, treating patients with hematologic malignancies for nearly 20 years. Helping patients live better lives is why I got into medicine, it’s what drove me to study the molecular mechanisms of cancer and aging, and it’s what has now brought me into public service.

We know that increasing drug prices present real challenges for patients and their families. The President and Secretary Azar have been deeply committed to exploring all potential solutions to combat drug prices that protect patient safety, are effective at delivering lower prices, and respect choice, innovation and access. While the FDA doesn’t regulate drug prices, we have made a concerted effort to examine our policies and explore ways we can help address this challenge.

But 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 and we support the President and Secretary’s efforts.

Early on, I vowed that the guiding principles that will steer my priorities as Acting Commissioner are a commitment to science-based decision-making and prioritizing our efforts for the benefit of the public health.

Today’s announcement fits within that commitment. The Safe Importation Action Plan we’re describing today 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 would pose no additional risk to the public’s health and safety.

Specifically, the Safe Importation Action Plan outlines the government’s intention to pursue two pathways to allow safe importation of drugs originally intended for foreign markets:

First, through a notice of proposed rulemaking (NPRM), HHS and FDA would propose to rely on the authority under current federal law that would, when the rule is finalized, authorize pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs manufactured consistent with the FDA approval. The NPRM would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that the demonstration projects would achieve significant cost savings to the American consumer.

Secondly, in draft guidance, FDA would describe recommendations to manufacturers of FDA- approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. To use this pathway, the manufacturer would establish with the FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the U.S.

Rest assured that protecting patients is the highest priority of the FDA, and Americans can be confident that any efforts in this space will not sacrifice patient safety.

We recognize there are many operational challenges and questions that we need to overcome before these policies can be implemented. We look forward to sharing greater detail on these proposals and we welcome questions as we work through these policies. HHS and FDA will continue to work through these questions and look forward to announcing the NPRM and draft guidance for public comment in the coming months.

We know there will be hurdles ahead of us. In addition to advancing the two pathways we’re describing in the Action Plan, we’ll also continue our important and successful work through our Drug Competition Action Plan to increase competition and reign in prescription drug costs through advances in our generic drug and biosimilars programs.

Thank you.

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