CREATES Act of 2016

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.

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Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 14 June 2016

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 14 June 2016

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• Introduced in Senate

  summary · EN · 14 June 2016

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