SWMissourian

Judge Watford, 

 

It is a pleasure to have you here. Congratulations to you on your nomination, and thank you for your patience under the circumstances. 
 

I would like to go along the same path of questioning. With the doctrine of stare decisis, the Supreme Court tries to avoid overturning its own precedent. However, the Supreme Court has overturned its own precedent before, in well-known cases and more obscure ones. What do you think goes into the decision to overturn precedent? How would you apply these factors on the Court? 

Mr. President, 

 

I move for cloture on the bill and yield. 

Mr. President,

 

I continue to believe that the gentleman from Pennsylvania's insistence on addressing the NAFTA issue is best done as part of a separate debate. This bill is not about international trade or international relations at all. This is a bill about domestic policy aimed at assisting working class Americans. Injecting the intricacies of foreign policy into this only serves as a potential barrier to final passage or as a delay tactic. We would be better off without the posturing and saving foreign policy debate for more relevant bills.

 

With this in mind, I oppose the proposed amendment offered by the gentleman from Pennsylvania and urge my colleagues to oppose its inclusion in this bill.

 

I yield.

Mr. President,

 

I maintain my belief that the legislation these amendments would insert into this bill are better considered separately. I do not see the need to change the name of the bill, so I voted against Stewart I. I believe that prematurely pulling out of NAFTA without a real plan beforehand is a very poor idea, potentially jeopardizing millions of jobs and throwing unnecessary chaos into the markets. Regardless of the need to renegotiate or augment NAFTA, I think these facts stand, and that means I had to oppose Stewart III.

 

Regarding Stewart II, while I believe that the End Outsourcing Act is worth consideration by this august body, I do wonder if it should receive its own dedicated debate, separate from this one. However, as I do not oppose it in principle, nor could I find a specific reason to oppose it at this time, and with my and my constituents' own concerns over outsourcing, I voted present.

 

While changing the name of the bill is ultimately not a big deal, unilaterally withdrawing from NAFTA on such a short timeline--a huge, sudden departure from policy--is a very bad idea. More time, more consideration, more debate, and more diplomacy is necessary. I urge my colleagues to reject such a short-sighted amendment.

 

I yield.

Stewart I: Nay

Stewart II: Present

Stewart III: Nay

Welcome!

Yea

Mr. President, 

 

I think this bill would be best considered on its own merits without lumping in related but substantially different matters, especially international trade. Those are very important and impactful issues that deserve their own dedicated debate and attention, which shouldn’t detract from what we are aiming to do with this bill. We are not limited to one bill to address any given issue, after all. 
 

I yield. 

Senator Andrew Clarke, for himself and others (and with thanks to Rep. Takano), introduced the following bill: 

 

To make innovative technology loan guarantee support available for battery storage technologies.

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

SECTION 1. SHORT TITLE.

SEC. 2. BATTERY STORAGE TECHNOLOGIES.

“(11) Battery storage technologies for residential, industrial, or transportation applications.”.

 

PES: 

This bill amends the Energy Policy Act of 2005 to expand the categories of projects that are eligible for innovative technology loan guarantees to include a category of projects for battery storage technologies for residential, industrial, or transportation applications.

Senator Andrew Clarke, for himself and others (and with thanks to Sen. Blunt), introduced the following bill: 

 

To require Federal agencies and Federal courts to comply with address confidentiality programs, and for other purposes. 

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

SECTION 1. SHORT TITLE.

SEC. 2. DEFINITIONS.

PES: 

This bill requires each federal agency and federal court to accept, for any purpose for which an individual is required to provide an address to the agency or court, an address designated to that individual pursuant to an address confidentiality program. An individual who provides an address pursuant to such a program shall not be subject to any federal regulatory, civil, or criminal penalties for providing such address in lieu of the individual's actual physical address.

 

An address confidentiality program is a state-implemented program that provides a designated address in lieu of the individual's actual physical address to an individual who: (1) is determined to be at risk of being a victim of domestic violence, rape, sexual assault, human trafficking, or stalking or who otherwise fears for their safety; or (2) resides in the same household as such an individual.

 

An agency or court seeking to acquire such individual's actual address shall comply with applicable procedures of such a program. Such address shall be considered confidential and shall not be subject to a Freedom of Information Act request.

Senator Andrew Clarke, for himself and others (and with thanks to Sen. Shaheen) introduced the following bill: 

 

To advance the integration of clean distributed energy into electric grids, and for other purposes. 

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

SECTION 1. SHORT TITLE.

SEC. 2. FINDINGS.

Senators Andrew Clarke and John Carlsen, for themselves and others (and with thanks to Sen. Daines), introduced the following bill: 

 

A BILL

To amend the Internal Revenue Code of 1986 to provide a child tax credit for pregnant moms.

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 “Child Tax Credit for Pregnant Moms Act of 2017”.

 

SEC. 2. CHILD TAX CREDIT ALLOWED WITH RESPECT TO UNBORN CHILDREN.

(a) In General.—Subsection (c) of section 24 of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraph:

“(3) CREDIT ALLOWED WITH RESPECT TO UNBORN CHILDREN.—

“(A) IN GENERAL.—The term ‘qualifying child’ includes an unborn child for any taxable year if such child is born and issued a social security number before the due date for the return of tax (without regard to extensions) for the taxable year. For purposes of the preceding sentence, the term ‘social security number’ means a social security number issued to an individual by the Social Security Administration, but only if the social security number is issued to a citizen of the United States or is issued pursuant to subclause (I) (or that portion of subclause (III) that relates to subclause (I)) of section 205(c)(2)(B)(i) of the Social Security Act.

“(B) DOUBLE CREDIT IN CASE OF CHILDREN UNABLE TO CLAIM CREDIT.—In the case of any child who is not taken into account under subparagraph (A) for the taxable year immediately preceding the taxable year in which the child is born, the amount of the credit determined under this section with respect to such child for the taxable year of the child's birth shall be increased by 100 percent.

“(C) UNBORN CHILD.—For purposes of this paragraph—

“(i) UNBORN CHILD.—The term ‘unborn child’ means a child in utero.

“(ii) CHILD IN UTERO.—The term ‘child in utero’ means a member of the species homo sapiens, at any stage of development, who is carried in the womb.”.

(b) Effective Date.—The amendment made by this section shall apply to taxable years beginning after December 31, 2017.

 

PES: 

This bill amends the Internal Revenue Code, with respect to the child tax credit, to allow the credit to be used for an unborn child if the child is born and issued a Social Security number before the due date for the tax return (without regard to extensions) for the taxable year. 

The bill defines an "unborn child" as a member of the species homo sapiens, at any stage of development, who is carried in the womb.

If a child is not taken into account for the credit for the year immediately preceding the year of the child's birth, the bill doubles the amount of the credit allowed for the year of the birth.

 

S. 1

 

Senator Andrew Clarke, for Senator Carlsen, Senator Stewart, himself and others (and with thanks to Sen. Durbin), introduced the following bill: 
 

A BILL

To address the needs of workers in industries likely to be impacted by rapidly evolving technologies. 

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 “Investing in Tomorrow's Workforce Act of 2017”.

SEC. 2. FINDINGS.

Congress makes the following findings:

(1) In 2014, the United States spent just 0.1 percent of the Nation's Gross Domestic Product on labormarket policies, less than half of what the United States spent on labor market policies 30 years ago.

(2) The number of workers receiving federally supported training has declined in the past 3 decades as advances in technology have simultaneously shifted labormarket demand over time.

(3) As much as 47 percent of all jobs in the United States are at risk of being replaced by automation technology, and job losses from automation are more likely to impact workers making less than $40,000 annually.

(4) Strong Federal investment in expanding training services for workers whose jobs may be lost due to automation could prepare the United States workforce to better adapt to changes in the labor market and enter into skilled positions in technologically oriented occupations and industries.

(5) A focus on preparing the workforce of the United States for jobs that utilize advanced technologies could grow wages, increase economic productivity, and boost the competitiveness of the United States.

 

SEC. 3. DEFINITIONS.

In this Act:

(1) AUTOMATION.—The term “automation” means a device, process, or system that functions without continuous input from an operator, including—

(A) advanced technologies, such as—

(i) data collection, classification processing, and analytics; and

(ii) 3-D printing, digital design and simulation, and digital manufacturing;

(B) robotics, including collaborative robotics, and worker augmentation technology;

(C) autonomous vehicle technology; or

(D) autonomous machinery technology.

(2) DISLOCATED WORKER.—The term “dislocated worker” has the meaning given the term in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102).

(3) IN-DEMAND INDUSTRY SECTOR OR OCCUPATION.—The term “in-demand industry sector or occupation” has the meaning given the term in section 3 of that Act.

(4) INTEGRATED EDUCATION AND TRAINING.—The term “integrated education and training” has the meaning given the term in section 3 of that Act.

(5) ELIGIBLE PARTNERSHIP.—The term “eligible partnership” means an industry or sector partnership, as defined in section 3 of that Act, except that—

(A) for purposes of applying paragraph (26)(A)(iii) of that section, the term “institution of higher education” has the meaning given the term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001); and

(B) the partnership shall include representatives of—

(i) a State workforce development board or a local workforce development board; and

(ii) an economic development organization.

(6) LOCAL AND STATE WORKFORCE DEVELOPMENT BOARDS.—The terms “local workforce development board” and “State workforce development board” have the meanings given the terms in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102).

(7) SECRETARY.—The term “Secretary” means the Secretary of Labor.

(8) TRAINING SERVICES.—The term “training services” means training services described in section 134(c)(3)(D) of that Act (29 U.S.C. 3174(c)(3)(D)).

 

SEC. 4. GAO STUDY ON BARRIERS TO AND OPPORTUNITIES FOR RETRAINING WORKERS.

(a) Study.—

(1) IN GENERAL.—The Comptroller General of the United States shall conduct a study of the barriers to providing, and opportunities for improving, training for workers in industries that have, or are likely to have, high rates of job loss due to automation.

(2) CONTENTS.—In conducting the study, the Comptroller General shall study—

(A) considerations impacting, and strategies to improve data collection with respect to, the workforce in industries with high rates of job loss or a high likelihood of automation in the United States, including considerations and data collection strategies concerning—

(i) industries and occupations most likely to be impacted by automation, including—

(I) the geographical location of those industries and occupations;

(II) the annual average wages of those occupations; and

(III) demographic data on the race, gender, and age of workers in those industries and occupations;

(ii) employer-based training practices in those industries and occupations;

(iii) the frequency with which employers provide worker training to address skills needs and react to changes in the labor market; and

(iv) projected job losses;

(B) considerations impacting, and strategies to improve data collection with respect to, the workforce in in-demand industry sectors and occupations in the United States, such as advanced manufacturing, information technology, and health care, including considerations and data collection strategies concerning—

(i) industry sectors and occupations that may emerge or become in-demand industry sectors or occupations as a result of automation, including—

(I) the geographical location of those industry sectors and occupations;

(II) the average annual wages of those occupations; and

(III) demographic data on the race, gender, and age of workers in those occupations;

(ii) the skills and education needed to fill the positions in those industries;

(iii) employer-based training practices in those industry sectors; and

(iv) projected job gains;

(C) barriers to, and opportunities for, retraining workers in industries that have a high likelihood of being impacted by automation;

(D) the impact of the geographical location of workers and their access to transportation on the ability of the workers to access job training and related higher-skilled positions;

(E) the impact of workers’ access to other benefits and services, including child care, paid sick leave, paid family and medical leave, or a retirement plan, on the ability of the workers to access job training and related higher-skilled positions; and

(F) how reduced Federal funding for job training programs has impacted the ability of State and local governments, employers, and communities to respond to changes in the labor market, including rapidly evolving technologies.

(b) Report.—On completion of the study required by subsection (a), the Comptroller General of the United States shall prepare and submit to the appropriate committees of Congress a report concerning the results of the study.

 

SEC. 5. GRANTS TO IMPROVE TRAINING FOR WORKERS IMPACTED BY AUTOMATION.

(a) Grants Authorized.—

(1) IN GENERAL.—From the amounts appropriated under subsection (g), the Secretary of Labor shall award grants, on a competitive basis, to eligible partnerships to support demonstration and pilot projects relating to the training needs of workers who are, or are likely to become, dislocated workers as a result of automation.

(2) DURATION.—A grant awarded under this section shall be for a period not to exceed 3 years.

(b) Applications.—

(1) IN GENERAL.—To be eligible to receive a grant under this section, an eligible partnership shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably require.

(2) CONTENTS.—Each application submitted under paragraph (1) shall include a description of the demonstration or pilot project to be completed with the grant funds, which description shall include—

(A) a description of the members of the eligible partnership who will be involved in the demonstration or pilot program and the services each member will provide;

(B) a description of the training services that will be available to individuals participating in the demonstration or pilot project, which may include—

(i) a plan to train dislocated workers from industries likely to be impacted by automation and transition the workers into regionally in-demand industry sectors or occupations; and

(ii) a plan to partner with local businesses to retrain, upskill, and re-deploy workers within an industry as an alternative to layoffs;

(C) a plan to provide workers with technology-based skills training, which may include training to provide skills related to coding, systems engineering, or information technology security, in addition to other skills; and

(D) a description of the goals that the eligible partnership intends to achieve to upskill workers and prepare them for in-demand industry sectors or occupations.

(c) Priorities.—In awarding grants under this section, the Secretary shall give priority to—

(1) eligible partnerships that are located in an area with a high concentration of—

(A) industries with a higher likelihood of being impacted by automation; or

(B) industries included in in-demand industry sectors, as determined under subparagraphs (A)(i) and (B) of section 3(23) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102(23));

(2) eligible partnerships—

(A) with a plan to provide incumbent worker training—

(i) to assist workers in obtaining the skills necessary to retain employment or avert layoffs; or

(ii) that allows a worker working for an employer to acquire new skills that allow the worker to obtain a higher-skilled or higher-paid position with such employer; and

(B) that partner with local employers that intend to backfill the pre-training positions of the incumbent workers by hiring new workers to fill those positions;

(3) eligible partnerships that will provide workers with a transportation stipend, paid sick leave, paid family and medical leave, access to child care services, or other employment benefits; or

(4) eligible partnerships with a plan to develop a shared training curriculum that can be used across local and regional networks of employers and training providers.

(d) Use Of Funds.—An eligible partnership that receives a grant under this section shall use the grant funds for 1 or more of the following:

(1) Providing training services under the demonstration or pilot project, which may include training services that prepare workers for in-demand industry sectors or occupations.

(2) Providing assistance for employers in developing a staff position for an individual who will be responsible for supporting training services provided under the grant.

(3) Purchasing equipment or technology necessary for training services provided under paragraph (1).

(4) Providing job search and other transitional assistance to workers in industries with high rates of job loss.

(5) Providing a training stipend to workers for training services.

(6) Providing integrated education and training.

(e) Report.—Not later than 1 year after an eligible partnership’s completion of a demonstration or pilot project supported under this section, the eligible partnership shall prepare and submit to the Secretary a report regarding—

(1) the number of workers who received training services through the demonstration or pilot project, disaggregated by type of training service and the age, gender, and race of the workers;

(2) the number of such workers who successfully transitioned into a new position following completion of the training services;

(3) the number of individuals who successfully transitioned into an in-demand industry sector or occupation following completion of the training services;

(4) annual earnings data for individuals who have completed training services through the demonstration or pilot project;

(5) the percentage of individuals described in paragraph (4) who are in education or training activities, or in employment, during the second quarter after exit from the training services;

(6) the percentage of individuals described in paragraph (4) who are in education or training activities, or in employment, during the fourth quarter after exit from the training services; and

(7) any practices used by the partnership that should be considered best practices with respect to training workers in industries that have, or are expected to have, high rates of job loss as a result of automation.

(f) General Requirements.—An eligible partnership that receives a grant under this section shall use the grant funds in a manner that is consistent with the labor standards and protections described in section 181 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3241) and nondiscrimination provisions described in section 188 of such Act (29 U.S.C. 3248).

(g) Authorization Of Appropriations.—There are authorized to be appropriated to carry out this section such sums as may be necessary for the first 5 full fiscal years after the date of enactment of this Act.

 

SEC. 6. EXPANSION OF WORKER TRAINING SERVICES.

(a) Adult And Dislocated Worker Employment And Training.—Section 134(d)(1)(A) of the Workforce Innovation and Opportunity Act (29 U.S.C. 3174(d)(1)(A)) is amended—

(1) in clause (xi), by striking “and” at the end;

(2) in clause (xii), by striking the period and inserting “; and”; and

(3) by adding at the end the following:

“(xiii) training programs for individuals who are, or are likely to become, dislocated workers as a result of automation, including activities that prepare the individuals for occupations in the technology sector.”.

(b) National Dislocated Worker Grants.—Section 170 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3225) is amended—

(1) in subsection (b)(1)(A), by inserting “advances in automation technology,” before “plant closures,”; and

(2) by adding at the end the following:

“(e) Authorization Of Appropriations.—In addition to any funds reserved under section 132(a)(2)(A) to carry out this section, there are authorized to be appropriated to carry out this section $40,000,000 for each of fiscal years 2017 through 2019.”.

 

SEC. 7:  Ending Outsourcing

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“Sec. 280I. Outsourcing expenses.”.

 

 

 

 

 

 

 

 

 

 

 

“Sec. 280J. Limitations for outsourcing employers.”.

 

“Sec. 54BB. Recapture of credits for outsourcing employers.

“SEC. 54BB. RECAPTURE OF CREDITS FOR OUTSOURCING EMPLOYERS.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“Sec. 45S. Credit for insourcing expenses.”.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

“2327a. Contracts: consideration of outsourcing of jobs.”.

 

 

 

 

 

 

 

 

 

 

 

“3303a. Bidders outsourcing jobs: disclosure of outsourcing; consideration of outsourcing in award; exclusion from sources.”.

 

 

 

 

PES: 

This bill (1) directs the Government Accountability Office to study the barriers to providing, and opportunities for improving, training for workers in industries that have, or are likely to have, high rates of job loss due to automation; (2) directs the Department of Labor to award grants to eligible partnerships to support demonstration and pilot projects relating to the training needs of workers who are, or are likely to become, dislocated workers as a result of automation; and (3) expands training programs for such workers and funding for national dislocated worker grants.

Senators Andrew Clarke and John Carlsen, for Senator Fakhouri, Senator James, themselves and others (and with thanks to Sen. Klobuchar), introduced the following bill: 

 

A BILL

To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.

 

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 “Preserve Access to Affordable Generics and Biosimilars Act”.

 

SEC. 2. CONGRESSIONAL FINDINGS AND DECLARATION OF PURPOSES.

(a) Findings.—Congress finds the following:

(1) In 1984, the Drug Price Competition and Patent Term Restoration Act (Public Law 98–417) (referred to in this Act as the “1984 Act”), was enacted with the intent of facilitating the early entry of generic drugs while preserving incentives for innovation.

(2) Prescription drugs make up approximately 10 percent of the national health care spending.

(3) Initially, the 1984 Act was successful in facilitating generic competition to the benefit of consumers and health care payers, although 88 percent of all prescriptions dispensed in the United States are generic drugs, they account for only 28 percent of all expenditures.

(4) Generic drugs cost substantially less than brand name drugs, with discounts off the brand price averaging 80 to 85 percent.

(5) Federal dollars currently account for over 40 percent of the $325,000,000,000 spent on retail prescription drugs, and this share is expected to rise to 47 percent by 2025.

(6) (A) In recent years, the intent of the 1984 Act has been subverted by certain settlement agreements in which brand name companies transfer value to their potential generic competitors to settle claims that the generic company is infringing the branded company’s patents.

(B) These “reverse payment” settlement agreements—

(i) allow a branded company to share its monopoly profits with the generic company as a way to protect the branded company’s monopoly; and

(ii) have unduly delayed the marketing of low-cost generic drugs contrary to free competition, the interests of consumers, and the principles underlying antitrust law.

(C) Because of the price disparity between brand name and generic drugs, such agreements are more profitable for both the brand and generic manufacturers than competition and will become increasingly common unless prohibited.

(D) These agreements result in consumers losing the benefits that the 1984 Act was intended to provide.

(7) In 2010, the Biologics Price Competition and Innovation Act (Public Law 111–148) (referred to in this Act as the “BPCIA”), was enacted with the intent of facilitating the early entry of biosimilar and interchangeable follow-on versions of branded biological products while preserving incentives for innovation.

(8) Biological drugs play an important role in treating many serious illnesses, from cancers to genetic disorders. They are also expensive, representing more than 40 percent of all prescription drug spending.

(9) Competition from biosimilar and interchangeable biological products promises to lower drug costs and increase patient access to biological medicines. But “reverse payment” settlement agreements also threaten to delay the entry of biosimilar and interchangeable biological products, which would undermine the goals of BPCIA.

(b) Purposes.—The purposes of this Act are—

(1) to enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug and biosimilar biological product manufacturers that limit, delay, or otherwise prevent competition from generic drugs and biosimilar biological products; and

(2) to support the purpose and intent of antitrust law by prohibiting anticompetitive practices in the pharmaceutical industry that harm consumers.

 

SEC. 3. UNLAWFUL COMPENSATION FOR DELAY.

(a) In General.—The Federal Trade Commission Act (15 U.S.C. 44 et seq.) is amended by inserting after section 26 (15 U.S.C. 57c–2) the following:

“SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS AND BIOSIMILARS.

“(a) In General.—

“(1) ENFORCEMENT PROCEEDING.—The Commission may initiate a proceeding to enforce the provisions of this section against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product or biological product.

“(2) PRESUMPTION AND VIOLATION.—

“(A) IN GENERAL.—Subject to subparagraph (B), in such a proceeding, an agreement shall be presumed to have anticompetitive effects and shall be a violation of this section if—

“(i) an ANDA filer or a biosimilar biological product application filer receives anything of value, including an exclusive license; and

“(ii) the ANDA filer or biosimilar biological product application filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the ANDA product or biosimilar biological product, as applicable, for any period of time.

“(B) EXCEPTION.—Subparagraph (A) shall not apply if the parties to such agreement demonstrate by clear and convincing evidence that—

“(i) the value described in subparagraph (A)(i) is compensation solely for other goods or services that the ANDA filer or biosimilar biological product application filer has promised to provide; or

“(ii) the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement.

“(b) Limitations.—In determining whether the settling parties have met their burden under subsection (a)(2)(B), the fact finder shall not presume—

“(1) that entry would not have occurred until the expiration of the relevant patent or statutory exclusivity; or

“(2) that the agreement’s provision for entry of the ANDA product or biosimilar biological product prior to the expiration of the relevant patent or statutory exclusivity means that the agreement is procompetitive.

“(c) Exclusions.—Nothing in this section shall prohibit a resolution or settlement of a patent infringement claim in which the consideration granted by the NDA holder or biological product license holder to the ANDA filer or biosimilar biological product application filer, respectively, as part of the resolution or settlement includes only one or more of the following:

“(1) The right to market the ANDA product or biosimilar biological product in the United States prior to the expiration of—

“(A) any patent that is the basis for the patent infringement claim; or

“(B) any patent right or other statutory exclusivity that would prevent the marketing of such ANDA product or biosimilar biological product.

“(2) A payment for reasonable litigation expenses not to exceed $7,500,000.

“(3) A covenant not to sue on any claim that the ANDA product or biosimilar biological product infringes a United States patent.

“(d) Enforcement.—

“(1) ENFORCEMENT.—A violation of this section shall be treated as a violation of section 5.

“(2) JUDICIAL REVIEW.—

“(A) IN GENERAL.—Any party that is subject to a final order of the Commission, issued in an administrative adjudicative proceeding under the authority of subsection (a)(1), may, within 30 days of the issuance of such order, petition for review of such order in—

“(i) the United States Court of Appeals for the District of Columbia Circuit;

“(ii) the United States Court of Appeals for the circuit in which the ultimate parent entity, as defined in section 801.1(a)(3) of title 16, Code of Federal Regulations, or any successor thereto, of the NDA holder or biological product license holder is incorporated as of the date that the NDA or biological product license application, as applicable, is filed with the Commissioner of Food and Drugs; or

“(iii) the United States Court of Appeals for the circuit in which the ultimate parent entity of the ANDA filer or biosimilar biological product application filer is incorporated as of the date that the ANDA or biosimilar biological product application is filed with the Commissioner of Food and Drugs.

“(B) TREATMENT OF FINDINGS.—In a proceeding for judicial review of a final order of the Commission, the findings of the Commission as to the facts, if supported by evidence, shall be conclusive.

“(e) Antitrust Laws.—Nothing in this section shall modify, impair, limit, or supersede the applicability of the antitrust laws as defined in subsection (a) of the first section of the Clayton Act (15 U.S.C. 12(a)), and of section 5 of this Act to the extent that section 5 applies to unfair methods of competition. Nothing in this section shall modify, impair, limit, or supersede the right of an ANDA filer or biosimilar biological product application filer to assert claims or counterclaims against any person, under the antitrust laws or other laws relating to unfair competition.

“(f) Penalties.—

“(1) FORFEITURE.—Each party that violates or assists in the violation of this section shall forfeit and pay to the United States a civil penalty sufficient to deter violations of this section, but in no event greater than 3 times the value received by the party that is reasonably attributable to the violation of this section. If no such value has been received by the NDA holder or biological product license holder, the penalty to the NDA holder or biological product license holder shall be sufficient to deter violations, but in no event greater than 3 times the value given to the ANDA filer or biosimilar biological product application filer reasonably attributable to the violation of this section. Such penalty shall accrue to the United States and may be recovered in a civil action brought by the Commission, in its own name by any of its attorneys designated by it for such purpose, in a district court of the United States against any party that violates this section. In such actions, the United States district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate.

“(2) CEASE AND DESIST.—

“(A) IN GENERAL.—If the Commission has issued a cease and desist order with respect to a party in an administrative adjudicative proceeding under the authority of subsection (a)(1), an action brought pursuant to paragraph (1) may be commenced against such party at any time before the expiration of 1 year after such order becomes final pursuant to section 5(g).

“(B) EXCEPTION.—In an action under subparagraph (A), the findings of the Commission as to the material facts in the administrative adjudicative proceeding with respect to the violation of this section by a party shall be conclusive unless—

“(i) the terms of such cease and desist order expressly provide that the Commission’s findings shall not be conclusive; or

“(ii) the order became final by reason of section 5(g)(1), in which case such finding shall be conclusive if supported by evidence.

“(3) CIVIL PENALTY.—In determining the amount of the civil penalty described in this section, the court shall take into account—

“(A) the nature, circumstances, extent, and gravity of the violation;

“(B) with respect to the violator, the degree of culpability, any history of violations, the ability to pay, any effect on the ability to continue doing business, profits earned by the NDA holder or biological product license holder, compensation received by the ANDA filer or biosimilar biological product application filer, and the amount of commerce affected; and

“(C) other matters that justice requires.

“(4) REMEDIES IN ADDITION.—Remedies provided in this subsection are in addition to, and not in lieu of, any other remedy provided by Federal law. Nothing in this paragraph shall be construed to affect any authority of the Commission under any other provision of law.

“(g) Definitions.—In this section:

“(1) AGREEMENT.—The term ‘agreement’ means anything that would constitute an agreement under section 1 of the Sherman Act (15 U.S.C. 1) or section 5 of this Act.

“(2) AGREEMENT RESOLVING OR SETTLING A PATENT INFRINGEMENT CLAIM.—The term ‘agreement resolving or settling a patent infringement claim’ includes any agreement that is entered into within 30 days of the resolution or the settlement of the claim, or any other agreement that is contingent upon, provides a contingent condition for, or is otherwise related to the resolution or settlement of the claim.

“(3) ANDA.—The term ‘ANDA’ means an abbreviated new drug application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) or a new drug application filed under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)).

“(4) ANDA FILER.—The term ‘ANDA filer’ means a party that owns or controls an ANDA filed with the Food and Drug Administration or has the exclusive rights under such ANDA to distribute the ANDA product.

“(5) ANDA PRODUCT.—The term ‘ANDA product’ means the product to be manufactured under the ANDA that is the subject of the patent infringement claim.

“(6) BIOLOGICAL PRODUCT.—The term ‘biological product’ has the meaning given such term in section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)).

“(7) BIOLOGICAL PRODUCT LICENSE APPLICATION.—The term ‘biological product license application’ means an application under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).

“(8) BIOLOGICAL PRODUCT LICENSE HOLDER.—The term ‘biological product license holder’ means—

“(A) the holder of an approved biological product license application for a biological product;

“(B) a person owning or controlling enforcement of any patents that claim the biological product that is the subject of such approved application; or

“(C) the predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with any of the entities described in subparagraphs (A) and (B) (such control to be presumed by direct or indirect share ownership of 50 percent or greater), as well as the licensees, licensors, successors, and assigns of each of the entities.

“(9) BIOSIMILAR BIOLOGICAL PRODUCT.—The term ‘biosimilar biological product’ means the product to be manufactured under the biosimilar biological product application that is the subject of the patent infringement claim.

“(10) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION.—The term ‘biosimilar biological product application’ means an application under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) for licensure of a biological product as biosimilar to, or interchangeable with, a reference product.

“(11) BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FILER.—The term ‘biosimilar biological product application filer’ means a party that owns or controls a biosimilar biological product application filed with the Food and Drug Administration or has the exclusive rights under such application to distribute the biosimilar biological product.

“(12) DRUG PRODUCT.—The term ‘drug product’ has the meaning given such term in section 314.3(b) of title 21, Code of Federal Regulations (or any successor regulation).

“(13) NDA.—The term ‘NDA’ means a new drug application filed under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).

“(14) NDA HOLDER.—The term ‘NDA holder’ means—

“(A) the holder of an approved NDA application for a drug product;

“(B) a person owning or controlling enforcement of the patent listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the ‘FDA Orange Book’) in connection with the NDA; or

“(C) the predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with any of the entities described in subparagraphs (A) and (B) (such control to be presumed by direct or indirect share ownership of 50 percent or greater), as well as the licensees, licensors, successors, and assigns of each of the entities.

“(15) PARTY.—The term ‘party’ means any person, partnership, corporation, or other legal entity.

“(16) PATENT INFRINGEMENT.—The term ‘patent infringement’ means infringement of any patent or of any filed patent application, extension, reissue, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patents of addition, and extensions thereof.

“(17) PATENT INFRINGEMENT CLAIM.—The term ‘patent infringement claim’ means any allegation made to an ANDA filer or biosimilar biological product application filer, whether or not included in a complaint filed with a court of law, that its ANDA or ANDA product, or biological product license application or biological product, may infringe any patent held by, or exclusively licensed to, the NDA holder or biological product license holder of the drug product or biological product, as applicable.

“(18) STATUTORY EXCLUSIVITY.—The term ‘statutory exclusivity’ means those prohibitions on the approval of drug applications under clauses (ii) through (iv) of section 505(c)(3)(E) (5- and 3-year data exclusivity), section 527 (orphan drug exclusivity), or section 505A (pediatric exclusivity) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E), 360cc, 355a), or on the licensing of biological product applications under section 351(k)(7) (12-year exclusivity) or paragraph (2) or (3) of section 351(m) (pediatric exclusivity) of the Public Health Service Act (42 U.S.C. 262) or under section 527 of the Federal Food, Drug, and Cosmetic Act (orphan drug exclusivity).”.

(b) Effective Date.—Section 27 of the Federal Trade Commission Act, as added by this section, shall apply to all agreements described in section 27(a)(1) of that Act entered into after June 17, 2013. Section 27(f) of the Federal Trade Commission Act, as added by this section, shall apply to agreements entered into on or after the date of enactment of this Act.

 

SEC. 4. CERTIFICATION OF AGREEMENTS.

Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (21 U.S.C. 355note) is amended by adding at the end the following:

“(d) Certification.—The Chief Executive Officer or the company official responsible for negotiating any agreement under subsection (a) or (b) that is required to be filed under subsection (c), within 30 days after such filing, shall execute and file with the Assistant Attorney General and the Commission a certification as follows: ‘I declare that the following is true, correct, and complete to the best of my knowledge: The materials filed with the Federal Trade Commission and the Department of Justice under section 1112 of subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, with respect to the agreement referenced in this certification—’

“(1) represent the complete, final, and exclusive agreement between the parties;

“(2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the referenced agreement; and

“(3) include written descriptions of any oral agreements, representations, commitments, or promises between the parties that are responsive to subsection (a) or (b) of such section 1112 and have not been reduced to writing.”.

 

SEC. 5. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting “section 27 of the Federal Trade Commission Act or” after “that the agreement has violated”.

 

SEC. 6. COMMISSION LITIGATION AUTHORITY.

Section 16(a)(2) of the Federal Trade Commission Act (15 U.S.C. 56(a)(2)) is amended—

(1) in subparagraph (D), by striking “or” after the semicolon;

(2) in subparagraph (E), by inserting “or” after the semicolon; and

(3) inserting after subparagraph (E) the following:

“(F) under section 27;”.

 

SEC. 7. STATUTE OF LIMITATIONS.

The Federal Trade Commission shall commence any enforcement proceeding described in section 27 of the Federal Trade Commission Act, as added by section 3, except for an action described in section 27(f)(2) of the Federal Trade Commission Act, not later than 6 years after the date on which the parties to the agreement file the certification under section 1112(d) of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (21 U.S.C. 355note).

 

SEC. 8. SEVERABILITY.

If any provision of this Act, an amendment made by this Act, or the application of such provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such Act or amendments to any person or circumstance shall not be affected.

 

PES: 

This bill amends the Federal Trade Commission Act to authorize the Federal Trade Commission to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and violates this bill if the filer of an abbreviated new drug (generic) application or a biosimilar biological product application: (1) receives anything of value; and (2) agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar biological product for any period of time.

Name: Andrew Clarke (D-MO) 

Media/Outlet: NBC

Reason: New Congress 

• I am looking forward to the new Congress. We have a divided government, but there’s a lot to be happy about for Democrats. We have a brand new President, the first Latina woman to ever hold the office. We have a majority in the Senate as well, and that includes two Democratic U.S. Senators from Missouri for the first time in decades. 
• But there is still a need for both practical and moral reasons to work with our Republican colleagues, and I look forward to that. We talk all the time about increased polarization, but I think we can find common ground. In Missouri, voters elected a Republican trifecta to govern the state but sent a Democratic Senator to Washington last year. There’s common ground here and I look forward to finding it and advancing solutions to the problems facing our country from it. 
• We must work to protect and expand healthcare access for working Americans. We must also work to raise real wages for all Americans, not just the wealthy elite. In light of recent events, we must work to secure our border, our streets, and our communities from violence, hate, and chaos. Additionally, our nation’s infrastructure problem must be addressed by leaders in Washington, and at the same time, we must ensure that future generations are not saddled with the consequences of irresponsible budgeting today. I think we can find common ground solutions to at least make great progress on all of these fronts. 
• Our primary focus should be on building a better future where everyday Americans are safe, prosperous, healthy, and free. Americans should be free to start families, buy decent homes, afford a decent living, believe as they wish, speak as they want, and go to sleep at night safe from violence and chaos in their communities. That’s the vision that I will continue to fight for in D.C. 

Wow, he’s from Michigan and Arkansas! He’s a true (Hillary) Clinton Democrat. 

Welcome back!

Welcome

Welcome!

Name: Andrew Clarke (D-MO) 

Media/Outlet: Fox News - The Kelly File 

Reason: 2016 Missouri Elections 

• The Missouri GOP nominated Catherine Hanaway to be our next Governor in the Show Me State. Catherine Hanaway and her political allies bullied former State Auditor Tom Schweich, also a Republican, into committing suicide with nasty public smears and a gross behind-the-scenes whisper campaign. Don’t just take it from me, take it from former Republican US Senator John Danforth—he’s saying the same thing. This is not the kind of gross behavior we need in the Governor’s Mansion, and I know that Republicans, Democrats, and Independents can agree on that. 
• Missouri is a potentially competitive state this year. All eyes are on Missouri. We need to loudly proclaim what our values are, independent of party labels. In Missouri, we value life, liberty, and the pursuit of happiness. We value smart, capable leadership that knows not to overstep. We value leaders who stand up for the working man. We value good, honest work supporting happy families. We value our faith in God and the community of believers around us. Chris Koster supports common sense like this. He’s a Missourian first, and he’ll put our state and the people’s values above all else, even party labels. That’s what we need—not another corrupt political bully bought by corporations. 
• I know I speak for all Missouri Democratic candidates on the ticket when I say we are not running on radical changes at the federal level to the Supreme Court, to the Senate, none of that. We are running to protect schools and boost education. We are running to ensure capable governance. We are running to raise wages and bring back jobs that support everyday families, all across the state from Cape Girardeau to St. Joseph, Kirskville to Mountain View, Joplin to Hannibal, and St. Louis to Kansas City. We are focused on the values and interests of Missouri, and that will always come first. 

Name: Andrew Clarke (D-MO)

Media/Outlet: NBC

Reason: Law and Order/Combatting Gun Violence, Crime, and Disorder 

• The basic job of the government is to protect the people from crime, disorder, and chaos. But right now, we are failing. There is an epidemic of gun violence and shootings in our cities, and now, we are seeing public land illegally occupied. 
• Armed occupation of public land undermines the safety of everyone by legitimizing violence as a means of solving problems instead of the justice system. I pray a peaceful and safe resolution is found quickly, but at the end of the day, we can not afford to normalize armed occupation of public land if we want a stable, safe country. 
• Gun violence is another problem that we must tackle head on because right now, governments across our country are failing to keep their citizens safe. There are meaningful changes and reforms we must pursue—closing loopholes, ensuring background checks are properly performed, keeping violent and abusive people from accessing guns—but we also have to make sure that we are also properly enforcing the laws we currently have. That means adequate funding for the justice system and law enforcement, sound practice and process, good training and education, and a commitment to upholding the rule of law. 
• Cities like my home of St. Louis are hit particularly hard by the epidemic of gun violence, but it’s a problem everywhere. Minority and underserved communities are disproportionately harmed, but it’s a problem none of us can afford to ignore. In order to have a just, equal country, we must have a country that respects and upholds law and order. That comes with electing responsible leaders on Election Day. 

Name: Andrew Clarke (D-MO) 

Media/Outlet: The Kelly File/Fox News

Reason: In Support of Reinstating Nebraska Death Penalty 

• I support Nebraska voters reinstating the state’s death penalty. As a former prosecutor and former Attorney General of Missouri, I am intimately familiar with the process that leads to the death penalty being levied against someone. Let me tell you, we aren’t executing some random schmuck who broke into a car at night or stole a pack of gum. We’re talking about hardened, dangerous, violent criminals—serial rapists, brutal murderers, truly depraved individuals. 
• The death penalty isn’t something we should take lightly, but it is an essential tool of justice. Some people are just so truly depraved and violent, and what they’ve done is so terrible, it is the only adequate means of punishment and prevention available. We are talking about the people who stand out even amongst other violent criminals, after all. 
• Not only is it pragmatic, but it is also essential for the morality and soul of the nation and trust in the justice system. How can you look the mother and father of a young woman who was kidnapped, brutally assaulted and tortured, before being killed and left in a barrel, in their eyes and tell them their daughter’s killer deserves to live? What kind of justice are they getting? I’ve seen terrible cases come across my desk throughout my many years as a prosecutor, and I know I could never do that. 
• Justice for the victims of crime and their families isn’t a partisan issue. We should never allow it to become one. That’s why I’m also throwing my support behind the effort to reinstate the death penalty in Nebraska. 

Senator Andrew Clarke Advocates for Minimum Wage Increase

KANSAS CITY, MO - Senator Andrew Clarke (D-MO) endorsed raising the federal minimum wage today while speaking to reporters in Kansas City, Missouri. Currently, the federal minimum wage is $7.25, while the statewide minimum wage in Missouri is $7.65. While there is a broad range of proposals--from $10.10 all the way up to $15.00, Senator Clarke believes that the vast majority of people can agree that at least some raise is needed, with $10.10 a good starting point.

 

"The minimum wage right now is still at a historical low. Raising it even to just $10.10, which I think is a good starting point for a deal, would put the minimum wage back to a comparable level as when I was a kid. We're talking about lifting millions of people out of poverty and increasing economic opportunity and activity hugely. Working Americans need a raise, and it is time we give them one," he told reporters.

 

Minimum wage increases have largely been blocked by Republicans at both the state and the federal level in an effort to protect the profits of their corporate donors. "They say that they're just worried about killing jobs, but economists have studied this time and time again, and the results are clear. A reasonable minimum wage increase would see a net increase in new jobs, meaning people get paid more without forcing millions of people out of the job market," Senator Clarke explained.

 

Ultimately, the likelihood of a minimum wage increase passing a Republican-controlled Congress is slim. The issue will come down to voters across the country as they elect their US Representatives and Senators, along with a new President. "I think people are ready for a Congress that fights for working people again," Senator Clarke said, "not one that protects the interests of wealthy Wall Street elites."

Clarke: Border Security "Absolutely an Issue That Must be Addressed" During Campaign

ST. LOUIS, MO - Speaking to reporters about the upcoming presidential campaign back in his home state of Missouri, Senator Andrew Clarke (D-MO) highlighted the importance of issues from the economy to crime and national security. Particularly, he highlighted the importance he believes issues surrounding border security and immigration will play.

 

"Immigration and border security, these are two issues that the public has practically been screaming at Washington to address for years," he said. "Every time it looks like we have some progress, something that will finally bring some solutions from the table into reality, it gets shot down. It happened back during the Bush Administration, and it happened just a couple years ago with the bipartisan border security agreement. This is an issue that isn't going away. It is absolutely an issue that must be addressed by every candidate who wants to win in 2016."

 

Senator Clarke has been a big proponent of increased security infrastructure and strengthened enforcement along the southern border. "That's why I supported the bipartisan agreement in 2013. You could argue that it wasn't perfect, sure, but you'll never get 'perfect' out of Washington--you have to go with what is possible, what is better than what we have now." Senator Clarke says that anyone who wants to abandon the border as an issue or fails to address the understandable concerns of the American people is leaving a lot of votes on the table. "I see it every time I come back home to Missouri. No matter where I am in the state, it is an issue people are frustrated and angry about, year after year, and we aren't even a border state!"

 

Senator Clarke was quick to express the importance of other issues as well. "The economy and jobs, that is always going to rank at the top of people's concerns. Right now, we are in a state of stable improvement, but we are still facing problems with infrastructure, slow wage growth, gas price shocks, energy dependence on countries like Saudi Arabia and Russia, the loss of good jobs as plants and factories shut their doors, negative economic effects of climate change, rising costs of living, the list goes on and on. And that's not to mention healthcare costs, rising education costs and poor funding, the terrible toll of crime and gun violence. All of these issues matter, and we need a candidate who has a plan to address them if we are going to win in 2016."