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.
- 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.”
- 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.”
- 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.”
- 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.”
- 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.
Nicole Longo
Nicole Longo is Deputy Vice President of public affairs at PhRMA focusing on Medicare, 340B, importation and more. She previously worked for a D.C.-based public affairs firm where she assisted a wide range of clients with communications efforts on everything from trade policy to agriculture policy to health care policy. Outside the office, Nicole can be found trying new restaurants (usually Italian), taking an occasional barre class and cheering on the Cincinnati Bengals.
Nicole Longo
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Prescription Drug Safety
Importation
Drug Importation
PhRMA submits comments on FDA’s proposed rule on drug importation
PhRMA submits comments on FDA’s proposed rule on drug importation