S 1778 · 111th Congress 2009–2011, ended

Access to Affordable Medicines Act

Fact sheet

Latest action · Oct 14, 2009 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedOct 14, 2009
  2. Passed SenateNot reached
  3. Passed HouseNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

Summary

Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered misbranded) if: (1) the revision has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period for the drug; (2) the Secretary has not determined the applicable labeling text when such period expires; (3) the labeling revision does not include a change to the warnings section; (4) the Secretary does not deem that the continued presence in commerce of the labeling before the revision adversely impacts the safe use of the drug; and (5) the sponsor of the application agrees to submit revised labeling not later than 60 days after the notification of any changes required by the Secretary.

Cosponsors 2

Members who signed on, in the order they did. Signatures ran from Oct 14, 2009 to Nov 2, 2009, with 1 there on the day it was introduced.

SeatCosponsorSigned on
R-LADavid VitterOriginalOct 14, 2009
D-AKMark BegichNov 2, 2009

Actions 3

Everything that happened, newest first.

  1. Oct 14, 2009Introduced in Senate
  2. Oct 14, 2009Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  3. Oct 14, 2009Sponsor introductory remarks on measure. (CR S10436-10437)

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Oct 14, 2009Introduced in Senate

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.