S.3056 - CREATES Act of 2016114th Congress (2015-2016)
|Sponsor:||Sen. Leahy, Patrick J. [D-VT] (Introduced 06/14/2016)|
|Committees:||Senate - Judiciary|
|Latest Action:||Senate - 06/21/2016 Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. (All Actions)|
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Summary: S.3056 — 114th Congress (2015-2016)All Information (Except Text)
Introduced in Senate (06/14/2016)
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.