S. 1778Senate111th Congress (2009-2011)In Committee

Access to Affordable Medicines Act

Introduced October 14, 2009

Legislative Activity

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2 earlier actions
SenateIntro Referral Latest Action

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

October 14, 2009

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SenateIntro Referral

Introduced in Senate

October 14, 2009

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S10436-10437)

October 14, 2009

SenateIntro Referral

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

October 14, 2009

Floor Debate

4 members

What members said about S. 1778 on the floor

4 Democrats
Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Oct 14, 2009

Mr. President, today, I am pleased to join Senators Whitehouse and Sessions to introduce the Federal Judiciary Administrative Improvements Act of 2009, a bipartisan bill that would improve the…

Jeanne Shaheen
Sen. Jeanne ShaheenD-NH · Oct 14, 2009

Mr. President, I rise today to introduce two health care bills that will help control health care costs and provide patients with better care. I believe these bills are easy to understand and reflect…

Jeanne Shaheen
Sen. Jeanne ShaheenD-NH · Oct 14, 2009

Mr. President, I rise today to introduce two health care bills that will help control health care costs and provide patients with better care. I believe these bills are easy to understand and reflect…

Al  Franken
Sen. Al Franken D-MN · Oct 14, 2009

Mr. President, all across the country, family dairy farms are in dire straits. In Minnesota alone, 200 dairy farms have closed this year. There is no single cause for this crisis. Family dairy…

Sheldon Whitehouse
Sen. Sheldon WhitehouseD-RI · Oct 14, 2009

Mr. President, I rise today to introduce the Federal Judiciary Administrative Improvements Act of 2009 on behalf of myself and the Chairman and Ranking Member of the Judiciary Committee, Senators…

Bill Text

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Introduced in SenateIssued October 14, 2009

II

111th CONGRESS

1st Session

S. 1778

IN THE SENATE OF THE UNITED STATES

October 14, 2009

Mrs. Shaheen (for herself and Mr. Vitter) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act with respect to generic drugs, and for other purposes.

1.

Short title

This Act may be cited as the Access to Affordable Medicines Act.

2.

Labeling changes

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the following:

(10)

If the proposed labeling of a drug that is the subject of an application under this subsection is different from the labeling of the listed drug at the time the Secretary evaluates the application under this subsection, the drug that is the subject of such application shall, notwithstanding any other provision of this Act, be eligible for approval and shall not be considered misbranded under section 502 if—

(A)

a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period that otherwise prohibited the approval of the drug under this subsection;

(B)

the Secretary has not determined the applicable text of the labeling for the drug that is the subject the application under this subsection at the time of expiration of such patent or exclusivity period;

(C)

the labeling revision described under subparagraph (A) does not include a change to the Warnings section of the labeling;

(D)

the Secretary does not deem that the continued presence in commerce of the labeling of the listed drug (as in effect before the revision described under subparagraph (A)) adversely impacts the safe use of the drug;

(E)

the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and

(F)

such application otherwise meets the applicable requirements for approval under this subsection.

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