H.R. 3375: Fair Prescription Drug Prices for Americans Act

The Fair Prescription Drug Prices for Americans Act aims to regulate the retail list prices of certain prescription drugs and biological products in the United States. The key provisions of the bill are outlined as follows:

Definitions

The bill defines specific terms relevant to its implementation:

• Biological Product: A biological product is one that is licensed under certain sections of the Public Health Service Act.
• Drug: This refers to a drug that has been approved under specific sections of the Federal Food, Drug, and Cosmetic Act.
• Secretary: This term refers to the Secretary of Health and Human Services.

Price Regulation

The core provision of the bill establishes that:

• The retail list price for any drug or biological product in the United States must not exceed the average retail list price of that product in six specified countries: Canada, France, Germany, Italy, Japan, and the United Kingdom.

Price Calculation

The bill mandates that:

• The Secretary of Health and Human Services will calculate the average retail list price for each drug and biological product annually.
• This calculation will use data reported by manufacturers and information from publicly available materials in the aforementioned countries.

Punitive Measures

To enforce compliance, the bill includes provisions for civil monetary penalties:

• If a manufacturer sets a price exceeding the allowed limit, the Secretary may impose penalties based on the difference between the U.S. list price and the average price from the six countries, multiplied by the number of units sold.
• The penalty will apply for each unit of the drug or biological product sold over the set limit.

Data Reporting Requirements

Each manufacturer will be required to provide the Secretary with:

• The retail list price of the drug or biological product in the United States.
• The retail list price of the product in each of the six specified countries.

Implementation

The Secretary of Health and Human Services is tasked with issuing guidance and regulations to effectively implement the provisions outlined in this bill.

Relevant Companies

• PFE - Pfizer Inc.: The company produces a wide range of medications that may be subject to price caps under the bill.
• MRK - Merck & Co., Inc.: Another major pharmaceutical manufacturer that will need to adjust pricing strategies to comply with the new regulations.
• JNJ - Johnson & Johnson: With numerous biologic products on the market, compliance with price limitations could impact their revenues.
• NVS - Novartis AG: A global healthcare company that could be directly affected by the implementation of this act, as it may require adjustment of pricing structures to align with international averages.