S. 2300Senate109th Congress (2005-2007)In Committee

Lower PRICED Drugs Act

Introduced February 16, 2006

Legislative Activity

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3 earlier actions
SenateFloor Latest Action

Star Print ordered on the bill.

February 27, 2006

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SenateIntro Referral

Introduced in Senate

February 16, 2006

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S1420-1421)

February 16, 2006

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1421-1422)

February 16, 2006

SenateFloor

Star Print ordered on the bill.

February 27, 2006

Floor Debate

21 members

What members said about S. 2300 on the floor

6 Republicans15 Democrats
Barack Obama
Sen. Barack ObamaD-IL · Sep 28, 2006

Mr. President, I rise today to introduce the Lead Poisoning Reduction Act of 2006. I am pleased that Senator Clinton is joining me in this effort. Lead is a poison we have known about for a long…

Tom Harkin
Sen. Tom HarkinD-IA · Feb 16, 2006

Mr. President, today I, along with Mr. Enzi and Mr. Thomas are introducing the ``Competitive and Fair Agricultural Markets Act of 2006.'' This legislation seeks to even the playing field for…

Daniel K. Akaka
Sen. Daniel K. AkakaD-HI · Sep 28, 2006

Mr. President, I rise to introduce ``The Intelligence Community Audit Act of 2006,'' with Senator Lautenberg which would reaffirm the Comptroller General of the United States and head of the…

Max Baucus
Sen. Max BaucusD-MT · Feb 16, 2006

Mr. President, I rise to support one of our Nation's most important domestic policy issues--national security. I understand that some would expect me to say competitiveness or health care or farms or…

Christopher J. Dodd
Sen. Christopher J. DoddD-CT · Feb 16, 2006

Mr. President, I rise with my colleague from Virginia, Senator Warner, to introduce the Safe Teen and Novice Driver Uniform Protection, STANDUP, Act of 2006--an important piece of legislation that…

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Dianne Feinstein
Sen. Dianne FeinsteinD-CA · Feb 16, 2006

Mr. President, I rise today in support of the California Ocean and Coastal Protection Act, introduced by Senator Boxer and myself, to permanently protect California's coast from oil and gas drilling.…

Joseph R. Biden Jr.
Sen. Joseph R. Biden Jr.D-DE · Sep 28, 2006

Mr. President, I rise today to introduce the Homeland Security Trust Fund Act of 2006. And, I do so because it is my sincere belief, that in order to better prevent attacks here at home, we must…

Daniel K. Akaka
Sen. Daniel K. AkakaD-HI · Feb 16, 2006

Mr. President, I rise today to introduce legislation aimed to address the disposal of chemical weapons by the military from World War II until 1970. A report titled, Off-Shore Disposal of Chemical…

Hillary Rodham Clinton
Sen. Hillary Rodham ClintonD-NY · Sep 28, 2006

Mr. President, I am pleased today to introduce a bill that will help inform the Congress and the American people about our Nation's trade agreements. The trade policy debate here in Washington is…

Arlen Specter
Sen. Arlen SpecterR-PA · Feb 16, 2006

Mr. President, today, I am introducing legislation to overhaul the Mine Safety and Health Act to make this Nation's mines the safest in the world. The recent events at the Sago mine in Tallmansville…

Susan M. Collins
Sen. Susan M. CollinsR-ME · Feb 16, 2006

Mr. President, in recent years, we have become increasingly aware of the great challenges facing our Nation as our population ages. While much discussion revolves around health care, social security,…

Herb Kohl
Sen. Herb KohlD-WI · Sep 28, 2006

Mr. President, I rise today to introduce the Citizen Petition Fairness and Accuracy Act of 2006. This legislation will help speed the introduction of cost-saving generic drugs by preventing abuses of…

Carl Levin
Sen. Carl LevinD-MI · Feb 16, 2006

Mr. President, I am pleased today to be joined by Senators DeWine, Dorgan and Bond in introducing legislation that will save lives by increasing the number of kidneys available for transplantation.…

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Barbara Boxer
Sen. Barbara BoxerD-CA · Sep 28, 2006

Mr. President, today I rise to introduce the Latina Health Access Act. This important legislation addresses the serious health care access barriers, and consequently higher incidences of disease and…

Jeff Bingaman
Sen. Jeff BingamanD-NM · Sep 28, 2006

Mr. President, the legislation I am introducing today, entitled the ``Community Health Workers Act of 2006,'' would improve access to health education and outreach services to women in medically…

William H. Frist
Sen. William H. FristR-TN · Sep 28, 2006

Mr. President, 6 years ago, my great-nephew had some peanut butter. He was 13 months old. For most 13-month-old children, this wouldn't be an issue. But for McClain Portis, it was. You see,…

Barack Obama
Sen. Barack ObamaD-IL · Feb 16, 2006

Mr. President, as our Nation faces staggering healthcare costs, rising rates of chronic conditions, and a growing wage gap between the haves and the have-nots, we must acknowledge the vital…

John Warner
Sen. John WarnerR-VA · Feb 16, 2006

Mr. President, I rise today to introduce an important piece of legislation related to our Navy and National Security. The Department of Defense has submitted its report to the Congress on the…

Craig Thomas
Sen. Craig ThomasR-WY · Sep 28, 2006

Mr. President, I am pleased to rise today to introduce the ``Access to Physical Medicine and Rehabilitation Services Improvement Act of 2006.'' This bill would improve patient access to physical…

Debbie Stabenow
Sen. Debbie StabenowD-MI · Feb 16, 2006

Mr. President, I rise today to introduce the Lower PRICED Drugs Act. I want to thank Senator Trent Lott for joining me on this important legislation, and for his leadership in increasing the…

Daniel K. Inouye
Sen. Daniel K. InouyeD-HI · Feb 16, 2006

Mr. President, I rise to speak in support of the Commission on Wartime Relocation and Internment of Latin Americans of Japanese Descent Act. I am introducing this bill today in commemoration of…

Christopher J. Dodd
Sen. Christopher J. DoddD-CT · Sep 28, 2006

Mr. President, food allergies are an increasing food safety and public health concern in this country, especially among young children. I know first-hand just how frightening food allergies can be in…

Byron L. Dorgan
Sen. Byron L. DorganD-ND · Feb 16, 2006

Mr. President, I am pleased to join Senators Levin, DeWine and Bond to introduce the Kidney Transplant Clarification Act of 2006. This legislation will help save lives by increasing the number of…

Chuck Grassley
Sen. Chuck GrassleyR-IA · Sep 28, 2006

Mr. President, I am pleased to introduce the ``Fiscal Accountability, Integrity and Responsibility in SCHIP'' or FAIR-SCHIP Act. I am pleased to be joined in this effort by Senator Johnny Isakson,…

Bill Text

Latest available legislative text

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Introduced in SenateIssued February 16, 2006

II

109th CONGRESS

2d Session

S. 2300

IN THE SENATE OF THE UNITED STATES

February 16, 2006

Ms. Stabenow (for herself and Mr. Lott) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes.

1.

Short title

This Act may be cited as the Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act.

2.

Generic drug use certification

(a)

In general

Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is amended—

(1)

in clause (vii), by striking ; and and inserting a semicolon;

(2)

in clause (viii), by striking the period and inserting ; and;

(3)

by inserting after clause (viii) the following:

(ix)

if with respect to a listed drug product referred to in clause (i) that contains an antibiotic drug and the antibiotic drug was the subject of any application for marketing received by the Secretary under section 507 (as in effect before the date of enactment of the Food and Drug Administration Modernization Act of 1997) before November 20, 1997, the approved labeling includes a method of use which, in the opinion of the applicant, is claimed by any patent, a statement that—

(I)

identifies the relevant patent and the approved use covered by the patent; and

(II)

the applicant is not seeking approval of such use under this subsection.

; and

(4)

in the last sentence, by striking clauses (i) through (viii) and inserting clauses (i) through (ix).

(b)

Effective date

The amendments made by this section shall apply to any abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that is submitted on, before, or after the date of enactment of this Act.

3.

Preventing abuse of the thirty-month stay-of-effectiveness period

(a)

In general

Section 505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iii)) is amended—

(1)

in the second sentence by striking may order and inserting shall order; and

(2)

by adding at the end the following: In determining whether to shorten the thirty-month period under this clause, the court shall consider the totality of the circumstances, including whether the plaintiff sought to extend the discovery schedule, delayed producing discovery, or otherwise acted in a dilatory manner, and the public interest..

(b)

Effective date

The amendments made by this section shall apply to any stay of effectiveness period under section 505(j)(5)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iii)) pending or filed on or after the date of enactment of this Act.

4.

Ensuring proper use of pediatric exclusivity

(a)

Drug product

Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by striking drug each place it appears and inserting drug product.

(b)

Market exclusivity for new drugs

Section 505A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(b)) is amended—

(1)

in the matter preceding paragraph (1), by—

(A)

striking health and inserting therapeutically meaningful;

(B)

striking and after (which shall include a timeframe for completing such studies),; and

(C)

inserting , and based on the results of such studies the Secretary approves labeling for the new drug product that provides specific, therapeutically meaningful information about the use of the drug product in pediatric patients after in accordance with subsection (d)(3);

(2)

in paragraph (1)(A)—

(A)

in clause (i), by—

(i)

striking the period and inserting any period; and

(ii)

inserting that is applicable to the drug product at the time of initial approval after in subsection (j)(5)(F)(ii) of such section; and

(B)

in clause (ii), by—

(i)

striking the period and inserting any period; and

(ii)

inserting that is applicable to the drug product at the time of initial approval after of subsection (j)(5)(F) of such section; and

(3)

in paragraph (2)—

(A)

in subparagraph (A)—

(i)

in clause (i), by striking a listed patent and inserting a patent that was either listed when the pediatric study was submitted to the Food and Drug Administration or listed as a result of the approval by the Food and Drug Administration of new pediatric labeling that is claimed by the patent, and; and

(ii)

in clause (ii) by striking a listed patent and inserting a patent that was either listed when the pediatric study was submitted to the Food and Drug Administration or listed as a result of the approval by the Food and Drug Administration of new pediatric labeling that is claimed by the patent, and; and

(B)

in subparagraph (B), by striking a listed patent and inserting a patent that was either listed when the pediatric study was submitted to the Food and Drug Administration or listed as a result of the approval by the Food and Drug Administration of new pediatric labeling that is claimed by the patent, and.

(c)

Market exclusivity for already-Marketed drugs

Section 505A(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(c)) is amended—

(1)

in the matter preceding paragraph (1), by—

(A)

striking health and inserting therapeutically meaningful;

(B)

striking and after the studies are completed within any such timeframe,; and

(C)

inserting , and based on the results of such studies the Secretary approves labeling for the approved drug product that provides specific, therapeutically meaningful information about the use of the drug product in pediatric patients after in accordance with subsection (d)(3);

(2)

in paragraph (1)(A)—

(A)

in clause (i)—

(i)

by striking the period and inserting any period; and

(ii)

by inserting that is applicable to the drug product at the time of initial approval after in subsection (j)(5)(F)(ii) of such section; and

(B)

in clause (ii)—

(i)

by striking the period and inserting any period; and

(ii)

by inserting that is applicable to the drug product at the time of initial approval after of subsection (j)(5)(F) of such section; and

(3)

in paragraph (2)—

(A)

in subparagraph (A)—

(i)

in clause (i), by striking a listed patent and inserting a patent that was either listed when the pediatric study was submitted to the Food and Drug Administration or listed as a result of the approval by the Food and Drug Administration of new pediatric labeling that is claimed by the patent, and; and

(ii)

in clause (ii), by striking a listed patent and inserting a patent that was either listed when the pediatric study was submitted to the Food and Drug Administration or listed as a result of the approval by the Food and Drug Administration of new pediatric labeling that is claimed by the patent, and; and

(B)

in subparagraph (B), by striking a listed patent and by inserting a patent that was either listed when the pediatric study was submitted to the Food and Drug Administration or listed as a result of the approval by the Food and Drug Administration of new pediatric labeling that is claimed by the patent, and.

(d)

Three-month exclusivity

Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by—

(1)

by striking six months each place it appears and inserting three months;

(2)

by striking six-month each place it appears and inserting three-month;

(3)

by striking 6-month each place it appears and inserting three-month;

(4)

in subsection (b)(1)(A)(i), by striking four and one-half years, fifty-four months, and eight years, respectively and inserting four years and three months, fifty-one months, and seven years and nine months, respectively; and

(5)

in subsection (c)(1)(A)(i), by striking four and one-half years, fifty-four months, and eight years, respectively and inserting four years and three months, fifty-one months, and seven years and nine months, respectively.

(e)

Definition

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

(o)

Drug product

(1)

In general

For purposes of this section, the term drug product has the same meaning given such term in section 314.3(b) of title 21, Code of Federal Regulations (or any successor regulation).

(2)

Separate drug products

For purposes of this section, each dosage form of a drug product shall constitute a different drug product.

.

(f)

Technical corrections

Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended—

(1)

by striking subsection (c)(3)(D) each place it appears and inserting subsection (c)(3)(E); and

(2)

in subsection (n), by striking under subsection (a) or (c) and inserting under subsection (b) or (c).

(g)

Effective date

The amendments made by this section shall apply to requests by the Secretary of Health and Human Services for pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) after the date of enactment of this Act.

5.

Citizen petitions and petitions for stay of agency action

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)

Citizens petitions and petitions for stay of agency action

With respect to any petition that seeks to have the Secretary take, or refrain from taking, any form of action relating to the approval of an application submitted under subsection (b)(2) or (j), the following shall apply:

(1)

No delay of approval

The Secretary shall not delay approval of an application submitted under subsection (b)(2) or (j) while a petition is reviewed and considered. Consideration of a petition shall be separate and apart from the review and approval of an application submitted under either such subsection.

(2)

Timing of final agency action

The Secretary shall take final agency action with respect to a petition within six months of receipt of that petition. The Secretary shall not extend such six-month review period, even with consent of the petitioner, for any reason, including based upon the submission of comments relating to a petition or supplemental information supplied by the petitioner. If the Secretary has not taken final agency action on a petition by the date that is six months after the date of receipt of the petition, such petition shall be deemed to have been denied on such date.

(3)

Verification

The Secretary shall not accept for review a petition unless it is signed and contains the following verification: I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information which are unfavorable to the petition were disclosed to me. I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is filed on or about __________. I verify under penalty of perjury that the foregoing is true and correct., with the date of the filing of such petition inserted in the blank space.

(4)

Extension of period

The thirty-month period referred to in subsection (j)(5)(D)(i)(IV) shall automatically be extended by the amount of time that lapses from the date that the Secretary receives a petition and the date of final agency action on that petition, without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in part, that petition.

.