S 3056 · 114th Congress 2015–2017, ended

CREATES Act of 2016

Introduced Jun 14, 2016 Originated Senate Sponsor Patrick J. Leahy D-VT

Fact sheet

Latest action · Jun 21, 2016 Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedJun 14, 2016
  2. Passed SenateNot reached
  3. Passed HouseNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016

This bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved medication alleging that the license holder: (1) declined to make available sufficient quantities of the approved medication for the developer's testing; or (2) failed to agree on, or refused to allow the developer to join, a single, shared system of elements to assure safe use (ETASU) of the medication. (Under current law, a generic version of a medication with ETASU must join the brand name medication's system of ETASU unless the developer of the generic has a waiver from the Food and Drug Administration.) The bill does not apply to medications for which there is a shortage, unless the shortage will not be promptly resolved.

In a civil action regarding the availability of sufficient quantities of a medication, it is an affirmative defense that the license holder: (1) is not manufacturing or marketing the medication and does not have access to a supply of the medication to make available, or (2) sells the medication without restrictions through other entities and the developer can purchase sufficient quantities of the medication from those entities.

Cosponsors 11

Members who signed on, in the order they did. Signatures ran from Jun 14, 2016 to Sep 22, 2016, with 3 there on the day it was introduced.

SeatCosponsorSigned on
D-MNAmy KlobucharOriginalJun 14, 2016
R-IAChuck GrassleyOriginalJun 14, 2016
R-UTMike LeeOriginalJun 14, 2016
D-MOClaire McCaskillJun 21, 2016
R-MESusan M. CollinsJun 21, 2016
R-AZJohn McCainJul 14, 2016
D-CTRichard BlumenthalJul 14, 2016
R-LADavid VitterSep 13, 2016
D-RISheldon WhitehouseSep 13, 2016
D-ILRichard J. DurbinSep 22, 2016
R-ARTom CottonSep 22, 2016

Actions 3

Everything that happened, newest first.

  1. Jun 21, 2016Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.
  2. Jun 14, 2016Introduced in Senate
  3. Jun 14, 2016Read twice and referred to the Committee on the Judiciary. (Sponsor introductory remarks on measure: CR S3862-3863)

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Jun 14, 2016Introduced in Senate

Support LegiList

This page is free, carries no paywall, and is built and maintained by one person. If the record here is useful to you, a few dollars keeps it going.

$1 $5 $10

Processed by Stripe in a separate window. LegiList never sees card details.

Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.