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S 1778 111th Congress Senate Health Consumer affairs Drug safety, medical device, and laboratory regulation Prescription drugs

Access to Affordable Medicines Act

Introduced: October 14, 2009 Introduced by: Shaheen, Jeanne Democratic · New Hampshire See on congress.gov
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 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 14, 2009
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 14, 2009
Sponsor introductory remarks on measure. (CR S10436-10437)
Oct 14, 2009
Introduced in Senate
 Plain-English summary Congressional Research Service

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.

What's happening now October 14, 2009

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Committees of jurisdiction 1