H.R. 4398

Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch. A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition.

A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product.

A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition.