HR 58 IH

To amend section 804 of the Federal Food, Drug, and Cosmetic Act to correct impediments in the implementation of the Medicine Equity and Drug Safety Act of 2000.

January 3, 2001

Mr. DEUTSCH introduced the following bill; which was referred to the Committee on Energy and Commerce

To amend section 804 of the Federal Food, Drug, and Cosmetic Act to correct impediments in the implementation of the Medicine Equity and Drug Safety Act of 2000.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Medicine Equity and Drug Safety Act Corrections of 2001'.

SEC. 2. CORRECTION OF IMPEDIMENTS IN IMPLEMENTATION OF MEDICINE EQUITY AND DRUG SAFETY ACT OF 2000.

(a) ACCESS TO LABELING TO PERMIT IMPORTATION- Section 804 of the Federal Food, Drug, and Cosmetic Act (as added by section 745(c)(2) of Public Law 106-387) is amended--

(1) in subsection (b)--

(A) in paragraph (2), by striking `and' at the end ;

(B) in paragraph (3), by striking the period at the end and inserting `; and'; and

(C) by adding at the end the following paragraph:

`(4) specify a fair and reasonable fee that a manufacturer may charge an importer for the use of labeling of a covered product.';

(2) in subsection (e)(2), by inserting after `used only for purposes of testing' the following: `or the labeling of covered products'; and

(3) in subsection (h), by adding at the end the following sentence: `No manufacturer of a covered product may impose any condition for the privilege of an importer using labeling for a covered product, except a requirement that the importer pay a fee for such use established by regulation under subsection (a)(4).'.

(b) PREVENTING DISCRIMINATION AGAINST IMPORTERS- Section 804(h) of such Act is amended by inserting before the period at the end of the first sentence the following: `or that discriminates against a person on the basis of the person's importation of covered products imported pursuant to subsection (a) or the sale or distribution of such covered products'.

(c) CONDITIONS FOR TAKING EFFECT- Section 804(l) of such Act is amended in the matter preceding paragraph (1) by striking `This section shall become effective' and all that follows through `will' and inserting the following: `This section shall become effective only if the Secretary certifies to the Congress that, in the determination of the Secretary, there is a reasonable probability that the implementation of this section will'.

(d) ELIMINATION OF SUNSET- Section 804 of such Act is amended by striking subsection (m).

(e) AUTHORIZATION OF APPROPRIATIONS- Section 804 of such Act, as amended by subsection (d) of this section, is amended by inserting after subsection (l) the following subsection:

`(m) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated for fiscal year 2002 and each subsequent fiscal year such sums as may be necessary to carry out this section.'.

END