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BigPharma Has No Case Against Importation Asserts HHS

Washington, DC – The Campaign for Personal Prescription Importation released the following statement regarding the Health and Human Services motion to dismiss Case No. 1:20-cv-03402-TJK, regarding a lawsuit filed by the Pharmaceutical Research and Manufacturers of America (PhRMA), against the Health and Human Services Secretary Certification and Regulatory Rule on wholesale prescription drug importation.

“BigPharma has once again proven that they will stop at nothing to squeeze profits from American patients, and their case against prescription importation exemplifies why further Congressional action is needed to solidify Americans’ right to access affordable prescription drugs,” says Jack Pfeiffer, Executive Director of the Campaign for Personal Prescription Importation. “CPPI and its consumer advocates recognize that both Democrat and Republican HHS Secretaries support moving forward with plans for legal wholesale importation. However, by not including a legal pathway for personal importation, policymakers are missing the most obvious way to provide immediate relief for Americans struggling with the extraordinary cost of affording their medicines.”

Takeaways from HHS Motion to Dismiss:

  • HHS recognizes a clear statutory authority that importation (including personal importation) is possible under current law.

    • “The Federal Food, Drug, and Cosmetic Act (“FDCA”), which regulates drugs in interstate commerce, was twice amended by Congress to provide for importation of prescription drugs from Canada.” [p15/49]

    • “Congress in 2000 and again in 2003 enacted a statutory pathway under which certain prescription drugs could be imported from Canada, 21 U.S.C. § 384. Congress, however, conditioned the statute’s effectiveness on the Secretary of Health and Human Services’ certification that it would: (1) pose no additional risk to the public’s health and safety, and (2) result in a significant cost reduction to American consumers for covered drugs.” [p14/49]

  • Upon this filing, HHS Secretaries from both Republican and Democrat administrations support a framework for legal importation. Bipartisan support for importation is the new norm.

  • There are future impediments to wholesale importation programs becoming operational; X millions of Americans are already using personal importation (add Kaiser citation) to afford their medicines. “

What’s Next?

The federal court has yet to rule on either PhRMA lawsuit or the new HHS filing. Until we have a decision from the judges, we remain in a holding pattern. Depending on the decision, either party may file an appeal.

Two bills pending in the House and Senate could clarify laws regarding prescription importation and help to fully lift restrictions that can sometimes impede personal prescription importation. Both the Safe and Affordable Drugs from Canada Act of 2021 (S.259, H.R.832) and The Affordable and Safe Prescription Drug Importation Act of 2021 (S.920, H.R. 2181) would expand support for prescription importation and fully codify individuals rights to safely import prescription drugs from Canada.

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