September 26, 2019

Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

On September 20, 2019, Rhode Island Congressman David Cicilline introduced the Affordable Prescriptions for Patients Through Promoting Competition Act of 2019.  Cicilline explained that the Act seeks to “increase competition in the prescription drug market” by preventing drug manufacturers from attempting to switch patients from an expiring drug to a new exclusive drug. The bill has been referred to the Committee on the Judiciary.

The bill’s language focuses on the period beginning on the date a manufacturer receives notice of an abbreviated new drug application or biosimilar product license application and ending on the date 180 days after that generic drug or biosimilar product is first marketed. During this period, a manufacturer engages in unfair competition if, as proven by a preponderance of the evidence, the manufacturer engages in a “hard switch” or a “soft switch.” A “hard switch” occurs when a manufacturer (1) requests withdrawal of the approval for a listed drug or places it on the discontinued products list and (2) subsequently markets a “follow-on” drug or product—a product which has been approved through application or supplement for a change, modification, or reformulation to the previously-approved drug and that treats the same medical condition. A “soft switch” occurs when a manufacturer (1) takes actions that would not qualify as a “hard switch” but which “unfairly disadvantage” the listed drug relative to the follow-on drug, and then (2) sells a follow-on drug.