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S. 340: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.

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S. 340: A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.

116th Congress · introduced 2019-02-05 · Health · Latest: Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2019-02-05 · 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: Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22. 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

A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.

Plain summary

Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019 This bill generally allows the developer of a drug or biological product, such as a generic or biosimilar version of a drug, to bring a civil action against the license holder of an approved medication if the holder refuses to make available sufficient quantities of the approved medication for the developer's testing. The bill also establishes affirmative defenses to such a civil action. In addition, the bill authorizes drug manufacturers seeking Food and Drug Administration approval for a generic drug to use alternative methods to develop elements assure safe use of a drug.

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

A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.

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] · 41 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Chuck Grassley (R-IA), Amy Klobuchar (D-MN), Mike Lee (R-UT), Tammy Baldwin (D-WI), Richard Blumenthal (D-CT), Cory A. Booker (D-NJ), Susan M. Collins (R-ME), Tom Cotton (R-AR), Ted Cruz (R-TX), Steve Daines (R-MT), Richard J. Durbin (D-IL), Joni Ernst (R-IA), Deb Fischer (R-NE), Margaret Wood Hassan (D-NH), John Kennedy (R-LA), Angus S. King, Jr. (I-ME), Lisa Murkowski (R-AK), Rand Paul (R-KY), Mike Rounds (R-SD), Tina Smith (D-MN), Sheldon Whitehouse (D-RI), Todd Young (R-IN), Jeanne Shaheen (D-NH), Kevin Cramer (R-ND), Shelley Moore Capito (R-WV), Chris Van Hollen (D-MD), Mazie K. Hirono (D-HI), John Hoeven (R-ND), Kirsten E. Gillibrand (D-NY), Gary C. Peters (D-MI), Jack Reed (D-RI), Jacky Rosen (D-NV), Edward J. Markey (D-MA)

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-cong116-s340 · catalog fed-us-congress-bills-cong116 · updated 2026-11-15 by psicol fed-bills-cong116