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S. 1096119th CongressHealth
Preserve Access to Affordable Generics and Biosimilars Act
Sponsored by Sen. Amy Klobuchar (D-MN) · 8 active : 3 Republicans, 5 Democrats
Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
Where it standsBefore the Senate8 senators score as swing votes
Hasn’t passed either chamber
- Senate: next
- House: not yet
- President: not yet
Summary
, via Congress.govPreserve Access to Affordable Generics and Biosimilars Act
This bill prohibits parties from entering into any agreement that resolves or settles a patent claim related to the sale of a drug or biological product and that has anticompetitive effects. Such an agreement is presumed to have anticompetitive effects if the filer of a generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.
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An agreement is exempt if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a U.S. patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.
The bill provides for enforcement by the Federal Trade Commission (FTC). Violators are subject to penalties including the forfeiture of the 180-day marketing exclusivity period for a generic drug.
Additionally, when a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC and the Department of Justice concerning the agreement contains the complete agreement and any related agreements, including descriptions of any oral agreements or representations.
Committees and subjects
Committees
- Senate Committee on the Judiciary · SenateReported by · Markup by · Referred to
Subjects
- Administrative law and regulatory procedures
- Civil actions and liability
- Competition and antitrust
- Contracts and agency
- Federal Trade Commission (FTC)
- Intellectual property
- Judicial review and appeals
- Licensing and registrations
- Manufacturing
- Marketing and advertising
- Prescription drugs
How the Senate breaks down
- 8Swing 70–100
- 56Middle 30–70
- 36Entrenched 0–30
Members fall into . All 100 senators have enough data to score.
Key players in the Senate
Ranked by swing score, 0–100 · swing-v2, directional: only movement toward the other party counts, so members who sit further from the center than their party no longer score as swing votes.
Bars show each input from 0 to 100: ideology gap, scorecard gap, . is the seat’s partisan lean, and shows how much of the input data a score has.
Similar past votes, Senate
Earlier behind swing-v3’s inputLoading similar votes
Cosponsors
8 activeShow all 8 cosponsors
- Chuck Grassley (R-IA)
- Cory A. Booker (D-NJ)
- Joni Ernst (R-IA)
- Kevin Cramer (R-ND)
- Mark Kelly (D-AZ)
- Peter Welch (D-VT)
- Richard Blumenthal (D-CT)
- Richard J. Durbin (D-IL)
How the swing score works
Ideology gapHow far a member’s DW-NOMINATE voting score sits from their party’s median in the same chamber.
Scorecard gapHow far their Heritage Action and LCV ratings stray from their party’s average, using the groups’ votes on similar bills where available.
Cross-pressureHow strongly their district or state leans toward the other party, from our own computed partisan lean.
Similar votesHow often they voted against their own party on earlier roll calls about this bill or similar ones.
Committee bonusMembers of the committees handling the bill decide whether it moves, so they get a boost.
Cosponsor checkThe sponsor and active cosponsors have already committed, so they drop toward entrenched.
