[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1903 Introduced in Senate (IS)]


109th CONGRESS
  1st Session
                                S. 1903

     To amend title XIX of the Social Security Act to require drug 
  manufacturers to report the average manufacturer price and the best 
price of authorized generic drugs and any other drugs sold under a new 
  drug application approved under section 505(c) of the Federal Food, 
 Drug, and Cosmetic Act to the Secretary of Health and Human Services.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 20, 2005

Mr. Rockefeller (for himself, Mr. Specter, Mr. Schumer, and Mr. McCain) 
introduced the following bill; which was read twice and referred to the 
                          Committee on Finance

_______________________________________________________________________

                                 A BILL


 
     To amend title XIX of the Social Security Act to require drug 
  manufacturers to report the average manufacturer price and the best 
price of authorized generic drugs and any other drugs sold under a new 
  drug application approved under section 505(c) of the Federal Food, 
 Drug, and Cosmetic Act to the Secretary of Health and Human Services.

    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 ``Generic Prescription Drug Fairness 
Act of 2005''.

SEC. 2. IMPROVED REGULATION OF AUTHORIZED GENERIC DRUGS AND OTHER DRUGS 
              SOLD UNDER A NEW DRUG APPLICATION APPROVED UNDER SECTION 
              505(C) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Inclusion With Other Reported Average Manufacturer and Best 
Prices.--Section 1927(b)(3)(A) (42 U.S.C. 1396r-8(b)(3)(A)) is 
amended--
            (1) by striking clause (i) and inserting the following:
                            ``(i) not later than 30 days after the last 
                        day of each rebate period under the agreement--
                                    ``(I) on the average manufacturer 
                                price (as defined in subsection (k)(1)) 
                                for each covered outpatient drug for 
                                the rebate period under the agreement 
                                (including for each such drug that is 
                                an authorized generic drug or is any 
                                other drug sold under a new drug 
                                application approved under section 
                                505(c) of the Federal Food, Drug, and 
                                Cosmetic Act); and
                                    ``(II) for each single source drug, 
                                innovator multiple source drug, 
                                authorized generic drug, and any other 
                                drug sold under a new drug application 
                                approved under section 505(c) of the 
                                Federal Food, Drug, and Cosmetic Act, 
                                on the manufacturer's best price (as 
                                defined in subsection (c)(1)(C)) for 
                                such drug for the rebate period under 
                                the agreement;''; and
            (2) in clause (ii), by inserting ``(including for such 
        drugs that are authorized generic drugs or are any other drugs 
        sold under a new drug application approved under section 505(c) 
        of the Federal Food, Drug, and Cosmetic Act)'' after ``drugs''.
    (b) Conforming Amendments.--Section 1927 of such Act (42 U.S.C. 
1396r-8) is amended--
            (1) in subsection (c)(1)(C)--
                    (A) in clause (i), in the matter preceding 
                subclause (I), by striking ``or innovator multiple 
                source drug of a manufacturer'' and inserting ``, 
                innovator multiple source drug, or authorized generic 
                drug of a manufacturer, or any other drug of a 
                manufacturer that is sold under a new drug application 
                approved under section 505(c) of the Federal Food, 
                Drug, and Cosmetic Act''; and
                    (B) in clause (ii)--
                            (i) in subclause (II), by striking ``and'' 
                        at the end;
                            (ii) in subclause (III), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following:
                                    ``(IV) in the case of a 
                                manufacturer that approves, allows, or 
                                otherwise permits an authorized generic 
                                drug or any other drug of the 
                                manufacturer to be sold under a new 
                                drug application approved under section 
                                505(c) of the Federal Food, Drug, and 
                                Cosmetic Act, shall be inclusive of the 
                                lowest price for such authorized 
                                generic or other drug available from 
                                the manufacturer during the rebate 
                                period to any wholesaler, retailer, 
                                provider, health maintenance 
                                organization, nonprofit entity, or 
                                governmental entity within the United 
                                States, excluding those prices 
                                described in subclauses (I) through 
                                (IV) of clause (i).''; and
            (2) in subsection (k)--
                    (A) in paragraph (1)--
                            (i) by striking ``The term'' and inserting 
                        the following:
                    ``(A) In general.--The term''; and
                            (ii) by adding at the end the following:
                    ``(B) Inclusion of authorized generic drugs.--In 
                the case of a manufacturer that approves, allows, or 
                otherwise permits an authorized generic drug or any 
                other drug of the manufacturer to be sold under a new 
                drug application approved under section 505(c) of the 
                Federal Food, Drug, and Cosmetic Act, such term shall 
                be inclusive of the average price paid for such 
                authorized generic or other drug by wholesalers for 
                drugs distributed to the retail pharmacy class of 
                trade, after deducting customary prompt pay 
                discounts.''; and
                    (B) by adding at the end the following:
            ``(10) Authorized generic drug.--The term `authorized 
        generic drug' means a listed drug (as that term is used in 
        section 505(j) of the Federal Food, Drug, and Cosmetic Act 
        that--
                    ``(A) has been approved under section 505(c) of 
                such Act; and
                    ``(B) is marketed, sold, or distributed directly or 
                indirectly to retail class of trade under a different 
                labeling, packaging (other than repackaging as the 
                listed drug in blister packs, unit doses, or similar 
                packaging for use in institutions), product code, 
                labeler code, trade name, or trade mark than the listed 
                drug.''.
    (c) Effective Date.--The amendments made by this section take 
effect on October 1, 2005.

SEC. 3. APPLICATION OF BASIC REBATE FOR SINGLE SOURCE AND INNOVATOR 
              MULTIPLE SOURCE DRUGS.

    (a) In General.--Section 1927(c)(1) of the Social Security Act (42 
U.S.C. 1396r-8(c)(1)) is amended--
            (1) in subparagraph (A), in the matter preceding clause 
        (i), by striking ``or an innovator multiple source drug'' and 
        inserting ``, an innovator multiple source drug, or an 
        authorized generic drug or any other drugs sold under a new 
        drug application approved under section 505(c) of the Federal 
        Food, Drug, and Cosmetic Act''; and
            (2) in subparagraph (C)(i), by striking ``or innovator 
        multiple source drug'' and inserting ``, an innovator multiple 
        source drug, or an authorized generic drug or any other drugs 
        sold under a new drug application approved under section 505(c) 
        of the Federal Food, Drug, and Cosmetic Act''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
take effect on the date of enactment of this Act and shall apply to 
rebate agreements entered into or renewed on or after that date.
                                 <all>