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S. 3788119th CongressHealth
CLEAR LABELS Act
Sponsored by Sen. Rick Scott (R-FL) · 12 active : 11 Republicans, 1 Democrat
Latest action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 523.
Where it standsBefore the Senate7 senators score as swing votes
Hasn’t passed either chamber
- Senate: next
- House: not yet
- President: not yet
Summary
, via Congress.govConsumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act or the CLEAR LABELS Act
This bill requires drugs and active pharmaceutical ingredients made available in the U.S. market to be labeled with the names and locations of their manufacturers.
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Specifically, a finished, packaged drug product must be labeled with the name and place of business of (1) the original manufacturer (or manufacturers) of each active pharmaceutical ingredient; (2) the original manufacturer of the finished drug product; and (3) the packer or distributor, if any. This information must be printed on the product label or made available electronically. Active pharmaceutical ingredients (which are generally sold to manufacturers and researchers, not consumers) must also be labeled with the name and place of business of their original manufacturers.
Under the bill, the
original manufacturer
is the establishment that conducts the majority of the significant phases of manufacturing to produce the ingredient or product.
The Food and Drug Administration (FDA) has discretion to determine whether a violation of these requirements constitutes misbranding and to assess a civil fine. The FDA must consider certain factors in determining whether to assess a fine, including whether the violator was notified of their noncompliance and was provided an opportunity to correct the violation.
Finally, the FDA must coordinate with U.S. Customs and Border Protection to address any overlap between these requirements and existing requirements for imported drugs.
These provisions take effect five years after the bill is enacted.
Committees and subjects
Committees
- Senate Committee on Health, Education, Labor, and Pensions · SenateReported by · Markup by · Hearings by (full committee) · Referred to
Subjects
- Consumer affairs
- Manufacturing
- Prescription drugs
- Supply chain
How the Senate breaks down
- 7Swing 70–100
- 57Middle 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-v2Bars 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.
- 1
Susan M. CollinsRepublican · Maine · Lean D+4Senate Committee on Health, Education, Labor, and Pensions
Similar past votes, Senate
Earlier behind swing-v3’s inputLoading similar votes
Cosponsors
12 activeShow all 12 cosponsors
- Katie Boyd Britt (R-AL)
- Kirsten E. Gillibrand (D-NY)
- Ron Johnson (R-WI)
- Tommy Tuberville (R-AL)
- Ashley Moody (R-FL)
- Mike Lee (R-UT)
- Kevin Cramer (R-ND)
- James E. Risch (R-ID)
- Chuck Grassley (R-IA)
- Pete Ricketts (R-NE)
- Joni Ernst (R-IA)
- Alan Armstrong (R-OK)
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.
