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Affordable Prescriptions for Patients Act of 2023
7/16/2024, 11:08 AM
Summary of Bill S 150
One key provision of the bill is the establishment of a Prescription Drug Affordability Board, which would be responsible for setting limits on the prices of certain prescription drugs. This board would work to ensure that patients are not being charged exorbitant prices for necessary medications.
Additionally, the Affordable Prescriptions for Patients Act of 2023 aims to increase transparency in the pharmaceutical industry. The bill would require drug manufacturers to disclose the costs associated with producing their medications, as well as any financial assistance programs they offer to patients. Furthermore, the legislation includes measures to promote competition in the prescription drug market. This includes provisions to prevent pharmaceutical companies from engaging in anti-competitive practices, such as pay-for-delay agreements. Overall, the Affordable Prescriptions for Patients Act of 2023 seeks to address the rising costs of prescription medications and make them more accessible to all Americans. It is currently being debated in Congress, with supporters arguing that it will help lower healthcare costs and improve patient outcomes.
Congressional Summary of S 150
Affordable Prescriptions for Patients Act of 2023
This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products.
Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantially similar to an indication of the reference drug.
The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product.
A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.
