SF 3970

as introduced - 91st Legislature (2019 - 2020) Posted on 05/12/2020 07:58am

A bill for an act
relating to health; authorizing incentives for manufacturers that choose to import
certain drugs pursuant to "Pathway 2" of the safe importation action plan; proposing
coding for new law in Minnesota Statutes, chapter 62J.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [62J.85] PRESCRIPTION DRUG MANUFACTURER IMPORTATION
PATHWAY PLAN.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following terms have
the meanings given.
new text end

new text begin (b) "Drug product" or "drug" means a brand name drug or biological product that is
regulated as a drug and is intended for human use. The biological product must be licensed
pursuant to section 351 of the federal Public Health Act, United States Code, title 42, section
262, and does not include biological products such as blood and blood products that are
intended for transfusion or allogenic-, cellular-, or tissue-based products.
new text end

new text begin (c) "FD&C Act" means the federal Food, Drug, and Cosmetic Act, United States Code,
title 21, section 301, et seq.
new text end

new text begin (d) "Manufacturer" means an entity that:
new text end

new text begin (1) engages in the manufacture of a drug product; and
new text end

new text begin (2) sets or changes the wholesale acquisition cost of the drug product it manufactures.
new text end

new text begin (e) "Multimarket-approved product" or "MMA product" means a federal Food and Drug
Administration (FDA)-approved drug product that:
new text end

new text begin (1) was manufactured outside the United States and originally intended to be marketed
and authorized for sale in a foreign country;
new text end

new text begin (2) is subject to a new drug application or biologics license application supplement;
new text end

new text begin (3) is authorized by the manufacturer to be marketed in the United States;
new text end

new text begin (4) continues to meet the quality standards for marketing in its originally intended foreign
market; and
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new text begin (5) differs only from the FDA-approved drug or FDA-licensed biological product with
regard to the labeling statement.
new text end

new text begin (f) "Safe importation action plan" means the plan released by the Department of Health
and Human Services and the FDA allowing for the importation of drug products originally
intended for foreign markets.
new text end

new text begin Subd. 2. new text end

new text begin Application. new text end

new text begin This section applies to any MMA product in which the
manufacturer of the product has obtained a new National Drug Code (NDC) for the MMA
product and has imported the MMA product in compliance with the FD&C Act and any
regulations adopted by the FDA.
new text end

new text begin Subd. 3. new text end

new text begin Labeling. new text end

new text begin In addition to any FDA-approved labeling requirements, the label
on any MMA product imported and sold in Minnesota must identify that the product was
originally manufactured for sale in a country other than the United States.
new text end

new text begin Subd. 4. new text end

new text begin Incentives. new text end

new text begin (a) In order to facilitate importation of drugs pursuant to "Pathway
2" of the safe importation action plan, any MMA product offered for sale in Minnesota at
a cost that is at least ... percent lower than the wholesale acquisition cost for the
FDA-approved product manufactured in the United States shall be:
new text end

new text begin (1) included on the uniform preferred drug list and covered under the medical assistance
and MinnesotaCare programs; and
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new text begin (2) a covered drug under the state employee health plan pursuant to chapter 43A.
new text end

new text begin (b) Each health plan company must provide coverage for the MMA product that meets
the requirements in paragraph (a) if the FDA-approved drug product is covered by the health
plan company and must not impose any cost-sharing requirements for the MMA product.
new text end