Drug Importation

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Pharmacy Call to Action: FDA Drug Importation Proposal Jeopardizes Patient Safety

On December 23, 2019, the Food and Drug Administration (FDA) published a proposed rule that, if finalized, would create a program for the legal importation of certain drugs from Canada to the United States. FDA’s drug importation program is NOT a safe way to reduce drug prices, and it puts patients at risk. We are encouraging pharmacists to learn more about the proposed rule and have provided instructions on this page about how to submit comments to FDA.

 

Why This Matters

Pharmacists are the gatekeeper of safe medications between the supply chain and their patients. But the safeguards to protect Americans that are in place would be undermined if this proposal is finalized as written. This video explains how a drug importation program would work under this proposed rule and provides an overview of concerns with the rule as written.

 

Download The Backgrounder

For more information about how the proposed importation program would work, and how it impacts you and your patients, download our backgrounder. This document outlines the entities involved and provides an overview of where APhA and National Alliance of State Pharmacy Associations (NASPA) stand on the issues that would result if this proposed rule was finalized as written.  

Download Now

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Voice Your Comments To FDA

If you have concerns about the drug importation program, we encourage you to tell FDA! To help you provide comments to FDA! APhA and NASPA created a template letter to help you provide comments to FDA. There are three easy ways to use our template letter: 

  1. A Word version to download, and edit,
  2. A PDF version to download, or
  3. Copy the text at the bottom of the page to paste into the comment box.
 

How to submit comments to FDA by March 9, 2020:


Step 1. To comment, please visit, regulations.gov and select “Comment Now” in the upper right of the webpage.

Step 2. Follow the prompts to complete your submission.

Step 3. Extra credit: E-mail us a copy of your comments once you have submitted them to the FDA. 

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Text to copy and paste in comment box following Step 1.

 

 

ATTN: DOCKET FDA-2019-N-5711

Dear Commissioner Hahn:

Thank you for the opportunity to provide comments on the Food and Drug Administration’s proposed rule on importation of prescription drugs. As a pharmacist, I have an obligation to ensure that I provide safe, effective, high quality, and authentic drugs to my patients. The FDA drug approval process and the secure, closed drug distribution system in the United States (US) provide assurances that enable me to fulfill this obligation to my patients. FDA’s proposed drug importation program introduces unnecessary risks to patient safety and threatens my ability to optimize medication outcomes working with my patients, as these products are not distributed with the same safeguards as those products distributed in the US. The proposed program is also unlikely to result in a significant reduction in the cost of prescription drugs to the American consumer. I am writing to request that this proposed rule not be finalized.

The proposed importation program jeopardizes patient safety.

The proposed program bypasses important drug supply chain protections that were created to ensure that the drugs we provide to patients are safe. It creates drug supply chain gaps and vulnerabilities where counterfeits and other unsafe drugs could be introduced. This program would undermine the Drug Supply Chain Security Act (DSCSA), which ensures a closed supply chain to track and trace prescription drugs as they move from manufacturer to distributor to me, the pharmacist. These same safeguards do not exist in Canada. FDA’s proposed rule creates a patchwork of interim supply chain measures that introduce gaps and loopholes in the supply chain as drugs are distributed from Canada into the U.S. Pharmacies have invested time and money to put DSCSA systems in place, and the proposed rule creates a disincentive for further investment and compliance, especially for those pharmacies who are already financially constrained. I want to be able to reassure my patients that the drugs they are taking are safe, effective, high quality, and authentic. I cannot do that if there are drugs that are able to bypass DSCSA protective measures.

The proposed importation program is unlikely to produce significant cost savings to American consumers.

High drug costs are a significant problem for American consumers, and as a pharmacist, I see the negative outcomes of that problem every day. I am committed to finding solutions for my patients to ensure they have access to the medications they need, and I will continue to advocate for changes that I believe will have a real impact on lowering drug prices. FDA’s proposed importation program is not a workable solution to lowering drug costs. Most of the highest-cost drugs for American consumers are carved out of the program, such as insulin and other biologics. For the drugs that are included in the proposed program, the additional costs associated with relabeling, testing, complying with the DSCSA workaround, and developing recall and adverse event reporting systems for the imported drugs would outweigh any cost savings realized from purchasing the drugs from Canadian rather than U.S.-based sellers or distributors.

In conclusion, I urge you not to finalize the proposed rule on importation of prescription drugs. The risk to patient safety, combined with the lack of cost savings, makes this proposal an unworkable solution for my patients and for American consumers in general.