S. 1128Senate109th Congress (2005-2007)In Committee

Pharmaceutical Advertising and Prudent Purchasing Act

Sponsored by Ron WydenSen. Ron Wyden (D-OR)
Introduced May 26, 2005

Legislative Activity

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2 earlier actions
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Finance.

May 26, 2005

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SenateIntro Referral

Introduced in Senate

May 26, 2005

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S6056-6057)

May 26, 2005

SenateIntro Referral

Read twice and referred to the Committee on Finance.

May 26, 2005

Floor Debate

21 members

What members said about S. 1128 on the floor

9 Republicans12 Democrats
Lamar Alexander
Sen. Lamar AlexanderR-TN · May 26, 2005

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I would like to say a few words about the nomination of John Bolton. The Presiding Officer is a…

John McCain
Sen. John McCainR-AZ · May 26, 2005

Mr. President, I am pleased to join with Senator Lieberman today in introducing an amended version of the Climate Stewardship Act, which we introduced in February. The legislation we submit today…

George Allen
Sen. George AllenR-VA · May 26, 2005

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I rise to offer to my colleagues my strong and unequivocal support for John Bolton and his…

John F. Kerry
Sen. John F. KerryD-MA · May 26, 2005

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, what is the parliamentary situation? Fifty? How much does the majority have remaining? I thank…

Russell D. Feingold
Sen. Russell D. FeingoldD-WI · May 26, 2005

Mr. President, I rise to oppose the confirmation of John Bolton to be the next U.S. ambassador to the United Nations. I do not take this decision lightly. As the Senator from Virginia just pointed…

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George V. Voinovich
Sen. George V. VoinovichR-OH · May 26, 2005

Mr. President, first, I thank the Senator from South Carolina for his kind remarks about this Senator early today and this afternoon. What we are doing here today is what the Senate should be doing;…

Edward M. Kennedy
Sen. Edward M. KennedyD-MA · May 26, 2005

Mr. President, hate crimes are a violation of everything our country stands for. They send the poisonous message that some Americans deserve to be victimized solely because of who they are. They're…

Mel Martinez
Sen. Mel MartinezR-FL · May 26, 2005

Mr. President, I rise to strongly support the nomination of John Bolton to be the United States next permanent representative to the United Nations. I do so because I believe this is a man of great…

Joseph R. Biden Jr.
Sen. Joseph R. Biden Jr.D-DE · May 26, 2005

Mr. President, I rise to speak about the vote we will be casting at 6 o'clock today, the cloture vote. I had some opportunity to speak on the merits and demerits of the Bolton nomination yesterday…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · May 26, 2005

Mr. President, I rise today in opposition to the nomination of Undersecretary of State John Bolton as United States Ambassador to the United Nations, an institution which he has openly and repeatedly…

Barack Obama
Sen. Barack ObamaD-IL · May 26, 2005

Mr. President, let me begin my statement today by outlining what I think this debate is not about. I do not believe this debate is about Mr. Bolton being rude on occasion. This debate is not about…

Orrin G. Hatch
Sen. Orrin G. HatchR-UT · May 26, 2005

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I am pleased that, after much too long a delay, the Senate will meet its constitutional…

Harry Reid
Sen. Harry ReidD-NV · May 26, 2005

Mr. President, let me say at the outset, that I do not intend to vote for cloture on John Bolton, nor do I intend to support him for the position of United States Ambassador to the United Nations. As…

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Orrin G. Hatch
Sen. Orrin G. HatchR-UT · May 26, 2005

Mr. President, I rise today to introduce a bill, S. 1156, to extend and enhance a provision in the Internal Revenue Code that gives tax incentives for the production of electricity from renewable…

Dianne Feinstein
Sen. Dianne FeinsteinD-CA · May 26, 2005

Mr. President, I rise today to express my opposition to the nomination of John Bolton to be the next United States Ambassador to the United Nations. Simply put, he is the wrong man at the wrong time…

Barbara A. Mikulski
Sen. Barbara A. MikulskiD-MD · May 26, 2005

Mr. President, I rise today to speak on the nomination of John Bolton to be the United States Representative to the United Nations. I have three criteria I use to evaluate all executive branch…

Jon Kyl
Sen. Jon KylR-AZ · May 26, 2005

Mr. President, I rise in very strong support of John Bolton to be our next ambassador to the United Nations. I have known Mr. Bolton for a long time. He is a great individual, a great representative…

Olympia J. Snowe
Sen. Olympia J. SnoweR-ME · May 26, 2005

Mr. President, I rise today to introduce the Medicare Mental Health Copayment Equity Act of 2005 with my colleagues, Senator John Kerry, Senator Gordon Smith, and Senator Susan Collins. Briefly, our…

Joseph I. Lieberman
Sen. Joseph I. LiebermanD-CT · May 26, 2005

Mr. President, I rise today with my friend and colleague Senator John McCain to introduce a second version of our Climate Stewardship Act with improvements--the Climate Stewardship AND Innovation Act…

William H. Frist
Sen. William H. FristR-TN · May 26, 2005

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, in 15 minutes or so, we will vote on the nomination of Under Secretary of State John Bolton to…

Mary L. Landrieu
Sen. Mary L. LandrieuD-LA · May 26, 2005

Mr. President, over 50 years ago, Sir Winston Churchill uttered the immortal words, ``never in the field of human conflict has so much been owed by so many to so few.'' Although Prime Minister…

Ron Wyden
Sen. Ron WydenD-OR · May 26, 2005

Madam President, the cost of medicine is a matter of concern to every Senator. Today, Senator Sununu and I have introduced legislation to take a fresh approach to holding down the cost of medicines…

Ron Wyden
Sen. Ron WydenD-OR · May 26, 2005

Madam President, the cost of medicine is a matter of concern to every Senator. Today, Senator Sununu and I have introduced legislation to take a fresh approach to holding down the cost of medicines…

Edward M. Kennedy
Sen. Edward M. KennedyD-MA · May 26, 2005

Mr. President, would the Chair remind me when I have 2 minutes left, please. Mr. President, it is premature for this nomination even to be brought up before the Senate until we have the opportunity…

Bill Text

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Introduced in SenateIssued May 26, 2005

II

109th CONGRESS

1st Session

S. 1128

IN THE SENATE OF THE UNITED STATES

May 26, 2005

Mr. Wyden (for himself and Mr. Sununu) 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 provide for increased rebates under the medicaid program for prescription drugs that are directly advertised to consumers, to require other Federal programs purchasing or reimbursing for such drugs to establish payment and reimbursement mechanisms that reduce the costs of those drugs, and for other purposes.

1.

Short title

This Act may be cited as the Pharmaceutical Advertising and Prudent Purchasing Act.

2.

Increased rebates under the medicaid program for prescription drugs directly advertised to consumers

(a)

In general

Section 1927(b) of the Social Security Act (42 U.S.C. 1396r–8(b)) is amended by adding at the end the following:

(5)

Increase in amount of rebate for covered outpatient drugs directly advertised to consumers

(A)

In general

A rebate agreement under this subsection shall provide for an increase in the amount of the rebate determined under subsection (c) with respect to each covered outpatient drug of a manufacturer for which payment is made under the State program under this title if the manufacturer of such drug fails to certify to the Secretary that the drug was not directly advertised to consumers during the rebate period applicable to such agreement.

(B)

Adjustment of rebate formula

(i)

In general

Not later than 180 days after the date of enactment of this paragraph, the Secretary shall determine appropriate adjustments to make to the formula used to calculate the amount of a rebate under subsection (c) to determine the increased amount of the rebate required under subparagraph (A), including, to the extent the Secretary determines appropriate, to the application of the average manufacturer price and best price in such formula.

(ii)

Requirements

In determining the adjustments required under clause (i), the Secretary shall—

(I)

take into account the increased costs to the State program established under this title resulting from the purchase of covered outpatient drugs that are directly advertised to consumers; and

(II)

consult with manufacturers.

(C)

Definition of directly advertised to consumers

In this section, the term directly advertised to consumers means a reminder ad or product claim regarding a covered outpatient drug that is disseminated through radio, television, or other electronic media, print media, or outdoor advertising.

.

(b)

Effective date

The amendment made by this section applies to rebate agreements entered into or renewed under section 1927 of the Social Security Act (42 U.S.C. 1396r–8) on or after the date that is 180 days after the date of enactment of this Act.

3.

Reduced payment and reimbursement mechanisms for other federal programs that purchase or provide reimbursement for prescription drugs that are directly advertised to consumers

(a)

In general

Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services and the Secretary of Veterans Affairs each shall develop and implement procedures under which any master agreement, pricing agreement, or contract entered into on or after that date for the procurement or purchase of a covered drug or a covered outpatient drug by a Federal agency or reimbursement program described in subsection (b) shall provide that the agency or program shall pay a negotiated reduced price for such drug unless the manufacturer has certified to the head of the agency or program that the drug was not directly advertised to consumers during the 12-month period preceding the date of such procurement or purchase.

(b)

Federal agencies and programs described

For purposes of subsection (a), the Federal agencies and reimbursement programs described in this subsection are the following:

(1)

The Public Health Service, including health-related programs administered by the Indian Health Service, and health-related programs funded under the Public Health Service Act, including the drug pricing agreement program established under section 340B of such Act (42 U.S.C. 256b).

(2)

The Department of Veterans Affairs and the program of medical care furnished by the Secretary of Veterans Affairs.

(3)

The Department of Defense and the Defense Health Program.

(c)

Definitions

In this section:

(1)

Covered drug

The term covered drug has the meaning given that term in section 8126(h)(2) of title 38, United States Code.

(2)

Covered outpatient drug

The term covered outpatient drug has the meaning given that term in section 1927(k)(2) of the Social Security Act (42 U.S.C. 1396r–8(k)(2)).

(3)

Directly advertised to consumers

The term directly advertised to consumers means a reminder ad or product claim regarding a covered drug or a covered outpatient drug that is disseminated through radio, television, or other electronic media, print media, or outdoor advertising.

(4)

Manufacturer

The term manufacturer has the meaning given that term in section 8126(h)(4) of title 38, United States Code, and section 1927(k)(5) of the Social Security Act (42 U.S.C. 1936r–8(k)(5)).

(d)

Conforming amendments

(1)

Prescription drugs purchased by covered entities under agreements entered into under the public health service act

Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended—

(A)

in paragraph (1), by inserting or required under paragraph (11) after as provided by the Secretary; and

(B)

by adding at the end the following:

(11)

Reduced negotiated price for covered drugs advertised directly to consumers

(A)

In general

An agreement entered into under paragraph (1) shall provide that with respect to each covered drug of the manufacturer that is purchased by a covered entity, the price charged shall not exceed the reduced negotiated price for that drug in accordance with the procedures established under section 3(a) of the Pharmaceutical Advertising and Prudent Purchasing Act if the manufacturer fails to certify to the Secretary that the drug was not directly advertised to consumers during the 12-month period preceding the date of such purchase.

(B)

Definition of directly advertised to consumers

In subparagraph (A), the term directly advertised to consumers means a reminder ad or product claim regarding a covered outpatient drug that is disseminated through radio, television, or other electronic media, print media, or outdoor advertising.

.

(2)

Procurement of prescription drugs by the department of veterans affairs, department of defense, the public health service (including the indian health service) and the coast guard

Section 8126 of title 38, United States Code, is amended—

(A)

in subsection (a)—

(i)

in paragraph (3), by striking and at the end;

(ii)

by redesignating paragraph (4) as paragraph (5);

(iii)

in paragraph (5) (as redesignated by clause (ii)), by striking and (3) and inserting (3), and (4); and

(iv)

by inserting after paragraph (3), the following:

(4)

with respect to each covered drug of the manufacturer that is procured by a Federal agency described in subsection (b) under depot contracting systems, a national contract entered into by the Secretary, or under the Federal Supply Schedule, the price charged shall not exceed the reduced negotiated price for that drug in accordance with the procedures established under section 3(a) of the Pharmaceutical Advertising and Prudent Purchasing Act if the manufacturer fails to certify to the Secretary or the head of the Federal agency involved that the drug was not directly advertised to consumers during the 12-month period preceding the date of such procurement;

; and

(B)

in subsection (h), by adding at the end the following:

(7)

Directly advertised to consumers

The term directly advertised to consumers means a reminder ad or product claim regarding a covered drug that is disseminated through radio, television, or other electronic media, print media, or outdoor advertising.

.

(e)

Effective date

The amendments made by this section apply to master agreements, pricing agreements, and contracts entered into or renewed on or after the date that is 180 days after the date of enactment of this Act.

4.

Report to congress on strategies to reduce the cost of prescription drugs covered under medicare and other federal programs that are directly advertised to consumers

(a)

In general

Not later than January 1, 2007, the Secretary of Health and Human Services, in consultation with the Secretary of Veterans Affairs, shall submit a report to Congress that contains the following information:

(1)

The percentage of costs for prescription drugs that are directly advertised to consumers that are passed on to Federal agencies and programs that purchase or provide reimbursement for such drugs.

(2)

The 25 most frequently prescribed drugs that are directly advertised to consumers and are purchased or reimbursed by Federal agencies and programs.

(3)

The 25 most costly prescription drugs that are directly advertised to consumers and are purchased or reimbursed by Federal agencies and programs.

(4)

The aggregate amount spent by manufacturers of prescription drugs—

(A)

to directly advertise to consumers; and

(B)

for the 25 most costly prescription drugs that are directly advertised to consumers.

(5)

Mechanisms for Federal agencies and programs to share information concerning—

(A)

which prescription drugs are directly advertised to consumers;

(B)

the costs to Federal agencies and programs of such drugs; and

(C)

utilization, cost, and reimbursement data regarding the purchase of such drugs, separately identified with respect to the medicare program and other Federal agencies and programs, and disaggregated for age cohorts, gender, and diagnoses of the individuals using such drugs.

(6)

Recommendations for legislative or administrative changes or alternative strategies, separately identified with respect to the medicare program and other Federal agencies and programs, to ensure that Federal payments for prescription drugs are reduced for prescription drugs directly advertised to consumers.

(7)

Strategies to ensure that prescription drug utilization under Federal agencies and programs is based on health needs.

(8)

Such other recommendations for legislation or administrative action as the Secretary determines to be appropriate.

(b)

Definitions

In this section:

(1)

Directly advertised to consumers

The term directly advertised to consumers has the meaning given that term in section 1927(b)(5)(C) of the Social Security Act (as added by section 2(a)).

(2)

Federal agency and program

The term Federal agency and program means the Federal agencies and programs described in section 3(b) and includes the medicare program established under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).

(3)

Manufacturer

The term manufacturer has the meaning given that term in section 8126(h)(4) of title 38, United States Code, and section 1927(k)(5) of the Social Security Act (42 U.S.C. 1396r–8(k)(5)).