Colorado Cross-Disability Coalition Issues Public Comment on FDA Proposed Rule

WASHINGTON, March 10 -- Julie Reiskin, executive director of the Colorado Cross-Disability Coalition, Denver, has issued a public comment on the Food and Drug Administration's proposed rule entitled "Importation of Prescription Drugs". The comment was written on March 7, 2020, and posted on March 9, 2020:

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Thank you for your request for comments on the Food and Drug Administration's (FDA) Importation of Prescription Drugs Notice of Proposed Rulemaking (the NPRM or proposed rule). I am pleased to provide official comments.

I represent the Colorado Cross-Disability Coalition (CCDC). We are the state's largest disability rights organization and our mission is to advocate for social justice for people with all types of disabilities. We do a significant amount of policy advocacy on healthcare issues. We are proud of our record of advocating for and even championing solutions that improve life for people with disabilities while reducing the cost of government funded benefits.

Drug Importation is important to us because it allows people with chronic and/or serious medical conditions to obtain medications at an affordable (or more affordable) cost. Many people with disabilities are disabled and in need of significant and costly services because they could not get access to medications or other services when needed. Therefore a condition turned into a disability. Others with disabilities are often forced onto Medicaid because the cost of services they need, including but not limited to drugs, are so cost prohibitive that no person could pay for these services out of pocket, or even with insurance, so we are forced to use Medicaid. As people with disabilities are joining the workforce we should be able to leave public benefit programs like Medicaid and Medicare when we do not have needs such as long-term care. Regular services like medications and even medical equipment should not be so overpriced that it becomes unaffordable to all but the wealthiest. Even the few that have private insurance or Medicare often cannot get their needs met because even the copayment (if a percentage of the drug or equipment) is out of reach. If individuals can get medications at a reasonable cost, hopefully that will lead to better negotiation for government and other payers. These excessive costs are breaking our health care system.

We appreciate the progress of the Administration on the development of a plan to allow the importation of prescription drugs from Canada. Rising prescription drug prices in Colorado are making health care costs unsustainable. At the same time, drug prices in the United States are, on average, three times higher than in Canada./1

We are confident that importation of prescription drugs from Canada will improve their affordability and therefore accessibility, which is critical to the health and well-being of Coloradans.

Americans already receive many active drug ingredients and finished drugs from around the world. Importing drugs from Canada will not pose an additional safety risk to our already international supply chain. Allowing importation from Canada is a very reasonable approach to improve affordability without compromising safety.

Relative to the specifics of the draft rule, we request that a final rule provide as much flexibility as possible to ensure consumers have access to significant cost savings as required by federal law. A priority for us with respect to increasing access to affordable prescription drugs is the number of Foreign Sellers authorized under the proposed rule. We believe that the proposed restriction to one Foreign Seller will greatly limit the number of drugs Colorado will be able to import, thereby limiting the state's ability to provide access to the lower drug prices available through importation. Additionally, we feel strongly that the final rule should allow for importation programs to continue for longer than two-year periods. Providing price reductions to Coloradans through importation is critical; including a two-year limitation seems to intentionally discourage the participation of required key vendor partners, setting up the program to fail. We suggest allowing importation programs to be in place for ten years before requiring an extension by the FDA, perhaps including an interim review period early on.

We also support revisions to the proposed rules that reduce the influence and power of special interests like manufacturers and prioritize the affordability needs of consumers and Coloradans. For example, consider the provision in the proposed rule that halts implementation of the entire rule should one provision be stayed for any reason. This leaves space for special interest groups to stop implementation based on one complaint. Special interests are already trying to use every lever available to prevent importation. This broad provision risks implementation of the entire importation program which seems a serious and unnecessary risk to the program.

Finally, we recognize Canada's concerns about U.S. drug importation programs, particularly its impact on Canadian prescription drug supplies. We strongly encourage the Administration to actively and effectively address the voiced concerns of our Canadian neighbors, including enabling the importation of prescription drugs from other countries like the United Kingdom, Japan and the European Union member countries in order to reduce the burden on Canada to meet the growing U.S. supply demands.

Sincerely,

Julie Reiskin, LCSW

Executive Director

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Footnote:

1/ https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/U.S.%20vs.%20International%20Prescription%20Drug%20Prices_0.pdf

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=FDA-2019-N-5711-0001

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