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H.R. 5993House109th Congress (2005-2007)In Committee

To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.

Sponsored by Jo Ann EmersonRep. Jo Ann Emerson (R-MO)
Introduced July 28, 2006

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2 earlier actions
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Referred to the Subcommittee on Health.

Health Subcommittee

August 1, 2006

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HouseIntro Referral

Introduced in House

July 28, 2006

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

July 28, 2006

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

August 1, 2006

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Introduced in HouseIssued July 28, 2006

I

109th CONGRESS

2d Session

H. R. 5993

IN THE HOUSE OF REPRESENTATIVES

July 28, 2006

Mrs. Emerson (for herself, Mr. Moore of Kansas, Mr. Boozman, Mr. Wamp, and Mr. Berry) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.

1.

Prohibition of authorized generics

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

(o)

Prohibition of authorized generic drugs

(1)

In general

Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall manufacture, market, sell, or distribute an authorized generic drug, direct or indirectly, or authorize any other person to manufacture, market, sell, or distribute an authorized generic drug.

(2)

Authorized generic drug

For purposes of this subsection, the term authorized generic drug—

(A)

means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under subsection (c) for that listed drug seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection (j)(2)(B) with respect to that listed drug; and

(B)

does not include any drug to be marketed, sold, or distributed—

(i)

by an entity eligible for exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or

(ii)

after expiration or forfeiture of any exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).

.