Bill
Bill > HR5133
summary
Introduced
11/18/2019
11/18/2019
In Committee
11/21/2019
11/21/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
Prohibits, subject to certain exceptions, the practice of product hopping, which is presumed when a drug manufacturer obtains removal of a drug from the Food and Drug Administration's approved drug list, discontinues a drug, or markets a reformulation of an already approved drug during a certain period after which the manufacturer has been notified that a competing drug manufacturer has applied for generic drug approval.
AI Summary
This bill prohibits the practice of "product hopping," which is when a drug manufacturer removes an existing drug from the FDA's approved list, discontinues a drug, or markets a reformulation of an already approved drug during a certain period after a competing generic drug manufacturer has applied for approval. The bill provides exceptions to this prohibition if the manufacturer can demonstrate certain justifications, such as safety concerns or supply disruptions. The Federal Trade Commission is tasked with enforcing this provision, and manufacturers can seek judicial review of any final orders issued by the FTC. The bill applies to conduct occurring on or after the date of enactment.
Committee Categories
Government Affairs, Justice
Sponsors (6)
David Cicilline (D)*,
Ben Cline (R),
Doug Collins (R),
Lucy McBath (D),
Jerry Nadler (D),
F. James Sensenbrenner (R),
Last Action
Placed on the Union Calendar, Calendar No. 578. (on 12/24/2020)
Official Document
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