Medicaid Drug Rebate Program (MDRP) Requirements and FDA Guidance on Importation of Certain Drugs under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA)

Medicaid Drug Rebate Program (MDRP) Requirements and FDA Guidance on Importation of Certain Drugs under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA)

Today, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers that participate in the Medicaid Drug Rebate Program (MDRP) on the MDRP requirements relating to the importation of certain drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA) Section 801 importation guidance.  This section was recently updated by the Food and Drug Administration’s Importation of Prescription Drugs final guidance.  

Specifically, this guidance addresses three main topic areas:

1. Whether the imported products (referred to as Multi Market Approved, MMA products) described in the FDA final guidance be considered covered outpatient drugs and, therefore, subject to the requirements set forth in section 1927 of the Social Security Act (the Act) and therefore eligible for rebates; 
2. Should the manufacturer report a separate average manufacturer price (AMP) for the MMA product that is different from the other FDA-approved version of the same drug marketed under the same NDA?  
3. Should the manufacturer’s best price, as defined at § 1927(c)(1)(C) of the Act and 42 C.F.R. § 447.505 take into account the sales of the manufacturer’s MMA product.  

To learn more about this guidance please use the link below:

• Manufacturer Release: Medicaid Drug Rebate Program (MDRP) Requirements and Importation of Certain Drugs under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA)