CREATES Act of 2016

Key: what the circles and colors mean

Each circle is a bill. The ring fills as it moves through Congress:

IntroducedPassed one chamberPassed both chambersBecame law (gold)Resolution agreed to (full, dark)Failed or vetoed (gray)

Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.

Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.

Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

D LeahySponsor

11 cosponsors · 5 D, 6 R

3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

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

What it does: CRS summary · Introduced in Senate · Jun 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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: CREATES Act of 2016

Also known as: Creating and Restoring Equal Access to Equivalent Samples Act of 2016

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

Policy area: Health · Origin: Senate · Introduced: Jun 14, 2016

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.