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108th CONGRESS
1st Session

H. R. 2640

To provide greater access to affordable pharmaceuticals, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

June 26, 2003

Mr. KENNEDY of Rhode Island (for himself, Mr. FROST, and Ms. NORTON) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned


A BILL

To provide greater access to affordable pharmaceuticals, and for other purposes.

SECTION 1. SHORT TITLE.

SEC. 2. FINDINGS.

SEC. 3. GENERIC DRUG APPLICATION REVIEW.

SEC. 4. GENERIC DRUG EDUCATION.

SEC. 5. PRESCRIPTION DRUG ASSISTANCE PROGRAM; PROFITS FROM RESEARCH.

`TITLE XXIX--PHARMACY ASSISTANCE

`SEC. 2901. GRANTS.

`SEC. 2902. PROFITS FROM RESEARCH.

`SEC. 2903. REVOLVING FUND.

SEC. 6. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY PRESCRIPTION DRUG MANUFACTURERS.

`SEC. 280I. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY PRESCRIPTION DRUG MANUFACTURERS.

`Sec. 280I. Limitation on deductions for advertising by prescription drug manufacturers.'.

SEC. 7. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.

SEC. 8. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG APPLICANTS.

patent that is the subject of the certification is invalid or not infringed, or

the date because of extraordinary or unusual circumstances)--

SEC. 9. BIOEQUIVALENCE.

SEC. 10. FILING OF PATENT INFORMATION WITH THE FOOD AND DRUG ADMINISTRATION.

`(aa) a drug substance;

`(bb) a drug formulation;

`(cc) a drug composition; or

`(dd) a method of use;

`(aa) the patent does not claim the drug for which the application was approved; or

`(bb) the patent does not claim an approved method of using the drug.

END