PhRMA submits comments on FDA’s proposed rule on drug importation

Nicole Longo
Nicole Longo March 10, 2020

PhRMA submits comments on FDA’s proposed rule on drug importation.

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Yesterday, PhRMA submitted comments in response to the Food and Drug Administration’s proposed rule, “Importation of Prescription Drugs.” As PhRMA President and CEO Stephen J. Ubl stated when the proposal was released, “At a time when there are pragmatic policy solutions being considered to lower costs for seniors at the pharmacy counter and increase competition in the market, it is disappointing the Administration once again put politics over patients.”

Below are five key points PhRMA raised in its comments.

  1. Poses a Safety Risk: “The proposed rule impermissibly circumvents FDA’s regulatory regime by allowing unapproved and misbranded drugs to be imported under section 804 and increases the likelihood that adulterated drugs will enter the U.S. market. Further, the importation scheme would introduce consumer confusion and increase the risk of medication errors.”

  2. Will Not Result in Significant Savings for American Consumers: “HHS has not shown that its importation scheme would result in significant cost savings of the covered products for the American consumer. The proposed rule does not provide any cost calculations, and instead, FDA admits that it is unable to determine whether the proposed rule will result in significant cost reductions.”

  3. Would Exceed Authorities Under the Federal Food, Drug, and Cosmetic Act and Other Laws: “HHS’s proposal to certify based on temporary, limited, short term plans is inconsistent with section 804. … In addition to posing section 804 certification concerns, the proposed rule impermissibly requires the manufacturer to participate in importation in ways not sanctioned by the FDCA, FDA regulations, and other federal statutes.”

  4. Raises Constitutional and Other Legal Concerns: “The required attestation from the manufacturer to an Importer and the required provision of testing information and the manufacturer labeling amount to compelled speech and compelled subsidies in violation of the First Amendment. … [Additionally,] [c]ompelled disclosure of trade secrets and confidential commercial information (CCI) for competitor use violates the Takings Clause and requires just compensation.”

  5. Would Be Inconsistent with Treaty Obligations: “The proposed rule’s implementation of section 804 would be inconsistent with the World Trade Organization’s (WTO’s) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).”

PhRMA’s full comments are available here.

Topics: Prescription Drug Safety, Importation, Drug Importation