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S. 3056: CREATES Act of 2016

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S. 3056: CREATES Act of 2016

114th Congress · introduced 2016-06-14 · Health · Latest: Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2016-06-14 · official record
  2. Who proposed it: Sen. Leahy, Patrick J. [D-VT] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

CREATES Act of 2016

Plain 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.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

CREATES Act of 2016

Source: Congressional Research Service summary (Introduced in Senate)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Leahy, Patrick J. [D-VT] · 11 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Chuck Grassley (R-IA), Amy Klobuchar (D-MN), Mike Lee (R-UT), Susan M. Collins (R-ME), Richard Blumenthal (D-CT), Sheldon Whitehouse (D-RI), Richard J. Durbin (D-IL), Tom Cotton (R-AR)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)
Bill
A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong114-s3056 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114