S. 1416 · 116th Congress
Affordable Prescriptions for Patients Act of 2019
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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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CornynSponsor13 cosponsors · 5 D, 7 R, 1 I
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Blumenthal
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Capito
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Murray
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Kennedy
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Scott
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Hawley
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Durbin
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King
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Smith
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Peters
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Fischer
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McSally
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Toomey1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Affordable Prescriptions for Patients 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 .
What it does: CRS summary · Reported to Senate · Jun 28, 2019
Affordable Prescriptions for Patients 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.
This bill also limits the number of patents that may be included in infringement claims brought by approved biological product license holders against applicants for a biosimilar product license.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Affordable Prescriptions for Patients Act of 2019
Latest action (Jun 28, 2019): Placed on Senate Legislative Calendar under General Orders. Calendar No. 132.
Policy area: Commerce · Origin: Senate · Introduced: May 9, 2019
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.