DOCSLIB.ORG

Antitrust Concerns and the Fda Approval Process

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Antitrust Concerns and the Fda Approval Process ANTITRUST CONCERNS AND THE FDA APPROVAL PROCESS HEARING BEFORE THE SUBCOMMITTEE ON REGULATORY REFORM, COMMERCIAL AND ANTITRUST LAW OF THE COMMITTEE ON THE JUDICIARY HOUSE OF REPRESENTATIVES ONE HUNDRED FIFTEENTH CONGRESS FIRST SESSION JULY 27, 2017 Serial No. 115–27 Printed for the use of the Committee on the Judiciary ( Available via the World Wide Web: http://judiciary.house.gov U.S. GOVERNMENT PUBLISHING OFFICE 30–235 WASHINGTON : 2018 VerDate Sep 11 2014 06:19 Jun 07, 2018 Jkt 028040 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 E:\HR\OC\A235.XXX A235 COMMITTEE MEMBERSHIP ONE HUNDRED FIFTEENTH CONGRESS COMMITTEE ON THE JUDICIARY BOB GOODLATTE, Virginia, Chairman F. JAMES SENSENBRENNER, JR., JOHN CONYERS, JR., Michigan Wisconsin JERROLD NADLER, New York LAMAR SMITH, Texas ZOE LOFGREN, California STEVE CHABOT, Ohio SHEILA JACKSON LEE, Texas DARRELL E. ISSA, California STEVE COHEN, Tennessee STEVE KING, Iowa HENRY C. ‘‘HANK’’ JOHNSON, JR., Georgia TRENT FRANKS, Arizona THEODORE E. DEUTCH, Florida LOUIE GOHMERT, Texas LUIS V. GUTIE´ RREZ, Illinois JIM JORDAN, Ohio KAREN BASS, California TED POE, Texas CEDRIC L. RICHMOND, Louisiana JASON CHAFFETZ, Utah HAKEEM S. JEFFRIES, New York TOM MARINO, Pennsylvania DAVID CICILLINE, Rhode Island TREY GOWDY, South Carolina ERIC SWALWELL, California RAUL LABRADOR, Idaho TED LIEU, California BLAKE FARENTHOLD, Texas JAMIE RASKIN, Maryland DOUG COLLINS, Georgia PRAMILA JAYAPAL, Washington RON DESANTIS, Florida BRAD SCHNEIDER, Illinois KEN BUCK, Colorado JOHN RATCLIFFE, Texas MARTHA ROBY, Alabama MATT GAETZ, Florida MIKE JOHNSON, Louisiana ANDY BIGGS, Arizona SHELLEY HUSBAND, Chief of Staff and General Counsel PERRY APELBAUM, Minority Staff Director and Chief Counsel SUBCOMMITTEE ON REGULATORY REFORM, COMMERCIAL AND ANTITRUST LAW TOM MARINO, Pennsylvania, Chairman BLAKE FARENTHOLD, Texas, Vice-Chairman DARRELL E. ISSA, California DAVID CICILLINE, Rhode Island DOUG COLLINS, Georgia HENRY C. ‘‘HANK’’ JOHNSON, JR., Georgia KEN BUCK, Colorado ERIC SWALWELL, California JOHN RATCLIFFE, Texas PRAMILA JAYAPAL, Washington MATT GAETZ, Florida BRAD SCHNEIDER, Illinois (II) VerDate Sep 11 2014 06:19 Jun 07, 2018 Jkt 028040 PO 00000 Frm 00002 Fmt 5904 Sfmt 6646 E:\HR\OC\A235.XXX A235 C O N T E N T S JULY 27, 2017 OPENING STATEMENTS Page The Honorable Bob Goodlatte, Virginia, Chairman, Committee on the Judici- ary ......................................................................................................................... 5 The Honorable John Conyers, Jr., Michigan, Ranking Member, Committee on the Judiciary ................................................................................................... 4 The Honorable Tom Marino, Pennsylvania, Chairman, Subcommittee on Reg- ulatory Reform, Commercial and Antitrust Law, Committee on the Judici- ary ......................................................................................................................... 1 The Honorable David Cicilline, Rhode Island, Ranking Member, Sub- committee on Regulatory Reform, Commercial and Antitrust Law, Com- mittee on the Judiciary ........................................................................................ 3 WITNESSES Hon. Scott Gottlieb, M.D., Commissioner, Food & Drug Administration Oral Statement ..................................................................................................... 8 Mr. Markus H. Meier, Acting Director, Bureau of Competition and Assistant Director, Health Care Division, Federal Trade Commission Oral Statement ..................................................................................................... 10 Prof. David S. Olson, Esq., Associate Professor of Law, Boston College Law School Oral Statement ..................................................................................................... 27 Prof. Erika Lietzan, Esq., Associate Professor of Law, University of Missouri School of Law Oral Statement ..................................................................................................... 29 Mr. Alden Abbott, Esq., Deputy Director and Senior Legal Fellow, The Herit- age Foundation Oral Statement ..................................................................................................... 31 Prof. Aaron S. Kesselheim, M.D., M.P.H., Associate Professor of Medicine, Harvard Medical School Oral Statement ..................................................................................................... 32 ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD Responses to Questions for the Record from the Hon. Scott Gottlieb, M.D., Commis- sioner, Food & Drug Administration Statement and letters submitted by the Honorable Tom Marino, Pennsylvania, Chairman, Subcommittee on Regulatory Reform, Commercial and Antitrust Law, Committee on the Judiciary. This material is available at the Committee and can be accessed on the Committee Repository at: https://docs.house.gov/meetings/JU/JU05/20170727/106333/HHRG-115- JU05-20170727-SD002.pdf Article submitted by the Honorable David Cicilline, Rhode Island, Ranking Member, Subcommittee on Regulatory Reform, Commercial and Antitrust Law, Committee on the Judiciary. These materials are available at the Committee and can be accessed on the Committee Repository at: https://docs.house.gov/meetings/JU/JU05/20170727/106333/HHRG-115- JU05-20170727-SD003.pdf (III) VerDate Sep 11 2014 06:19 Jun 07, 2018 Jkt 028040 PO 00000 Frm 00003 Fmt 5904 Sfmt 6621 E:\HR\OC\A235.XXX A235 IV Page Oral Statement —Continued Statement submitted by the Honorable Bob Goodlatte, Virginia, Chairman, Com- mittee on the Judiciary. These materials are available at the Committee and can be accessed on the Committee Repository at: https://docs.house.gov/meetings/JU/JU05/20170727/106333/HHRG-115- JU05-20170727-SD005.pdf VerDate Sep 11 2014 06:19 Jun 07, 2018 Jkt 028040 PO 00000 Frm 00004 Fmt 5904 Sfmt 6621 E:\HR\OC\A235.XXX A235 ANTITRUST CONCERNS AND THE FDA APPROVAL PROCESS THURSDAY, JULY 27, 2017 HOUSE OF REPRESENTATIVES SUBCOMMITTEE ON REGULATORY REFORM COMMERCIAL AND ANTITRUST LAW COMMITTEE ON THE JUDICIARY Washington, DC. The Subcommittee met, pursuant to call, at 1:00 p.m., in room 2141, Rayburn House Office Building, Hon. Tom Marino (Chairman of the Subcommittee) presiding. Present: Representatives Marino, Goodlatte, Gaetz, Cicilline, Conyers, Johnson, Swalwell, and Schneider. Staff Present: Ryan Dattilo, Counsel; Andrea Woodard, Clerk; and Slade Bond, Minority Counsel. Mr. MARINO. Good morning. The Subcommittee on Regulatory Reform, Commercial and Antitrust Law will come to order. We are going to vote in anywhere from 20 to 30 minutes. I may be speaking a little faster than I normally do because I would like to get our opening statements in and our distinguished witnesses’ opening statements in. So let’s begin. Without objection, the Chair is authorized to declare a recess of the committee at any time. We welcome everyone to today’s hearing on antitrust concerns and the FDA approval process. And I now recognize myself for an opening statement. The Committee has a robust history of examining competition in the healthcare marketplace to ensure patients receive the highest quality treatment at the lowest cost. In the past few years, the Subcommittee has held four hearings in this area, covering the top- ics of market consolidation, the impact of the Patient Protection and Affordable Care Act on competition, opioid addiction, and trends in pharmacy benefit management. We continue that tradi- tion today, focusing on the pharmaceutical industry and antitrust concerns surrounding the FDA drug approval process. Competition in the pharmaceutical market involves a delicate balance. On one hand, we want to encourage pharmaceutical man- ufacturers to invest in needed, but often expensive research and de- velopment in order to bring innovative and life-saving drugs to the market. On the other hand, we want to encourage sufficient com- (1) VerDate Sep 11 2014 06:19 Jun 07, 2018 Jkt 028040 PO 00000 Frm 00005 Fmt 6633 Sfmt 6602 E:\HR\OC\A235.XXX A235 2 petition to ensure that there is an appropriate check on consumer prices. Innovation is one of the hallmarks of our pharmaceutical indus- try and should be celebrated. However, there have been allegations that some companies may be abusing their roles as innovators to engage in the manipulation of regulations to preclude generic man- ufacturers from bringing competing products to the market. Such conduct is anticompetitive and should be put to a stop. Since its enactment, the Hatch-Waxman Act has provided oppor- tunities for manufacturers to make lower-cost generic versions of previously approved drugs available to the people of the United States in a timely manner, thereby lowering overall prescription drug costs for patients and taxpayers by billions of dollars each year. An essential piece of this framework is the ability of generic drug manufacturers to obtain sufficient samples of branded drugs to con- duct the testing necessary to support an application for FDA ap- proval of the drugs’ generic version. Concerns have been raised that generic manufacturers have been prevented from obtaining such samples, in some instances based on the position that the drugs in question are subject to a risk evaluation and mitigation strategy with elements to assure safe use under Section 505-1, the Federal Food, Drug, and Cosmetic Act. This is more commonly re- ferred to as the REMS program. While the enforcement of existing antitrust laws could address the refusal by some branded manufacturers to
Load more

Recommended publications
  • Senate Section
    E PL UR UM IB N U U S Congressional Record United States th of America PROCEEDINGS AND DEBATES OF THE 116 CONGRESS, FIRST SESSION Vol. 165 WASHINGTON, WEDNESDAY, NOVEMBER 13, 2019 No. 181 Senate The Senate met at 10 a.m. and was crease of 4,000 from the previous year. at George Mason University’s Antonin called to order by the President pro However, the number of children wait- Scalia Law School. tempore (Mr. GRASSLEY). ing for adoption also increased. That Even the American Bar Association’s f number rose to 125,000. Unfortunately, Standing Committee on the Federal teenagers, sibling groups, and those Judiciary, which has lately—lately PRAYER with medical challenges often wait made headlines for treating President The Chaplain, Dr. Barry C. Black, of- much longer to be adopted. Every child Trump’s nominees in a less-than-even- fered the following prayer: deserves a safe, permanent, loving handed way, has rated this nominee Let us pray. home, so I want to commend all those ‘‘well-qualified.’’ Eternal God, hear us when we cry to who have chosen to adopt children in Obviously, a majority of our col- You. You have been our help in ages foster care. leagues on the Judiciary Committee past and our hope for the years to If you wonder where I get the opinion concurred, and now the entire Senate come. that it is unfortunate that people want will have the opportunity to confirm You don’t keep a record of our trans- a permanent, safe, and loving home, all yet another outstanding jurist to the gressions but shower us daily with you have to do is listen to the kids in Federal bench.
    [Show full text]
  • Nomination of Scott Gottlieb, M.D., to Serve As Commissioner of Food and Drugs Hearing Committee on Health, Education, Labor, An
    S. HRG. 115–341 NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS COMMISSIONER OF FOOD AND DRUGS HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED FIFTEENTH CONGRESS FIRST SESSION ON EXAMINING THE NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS COMMISSIONER OF FOOD AND DRUGS APRIL 5, 2017 Printed for the use of the Committee on Health, Education, Labor, and Pensions ( Available via the World Wide Web: http://www.gpo.gov/fdsys/ U.S. GOVERNMENT PUBLISHING OFFICE 25–027 PDF WASHINGTON : 2018 VerDate Nov 24 2008 14:29 Oct 15, 2018 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 S:\DOCS\25027.TXT CAROL HELPN-004 with DISTILLER COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS LAMAR ALEXANDER, Tennessee, Chairman MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont JOHNNY ISAKSON, Georgia ROBERT P. CASEY, JR., Pennsylvania RAND PAUL, Kentucky AL FRANKEN, Minnesota SUSAN M. COLLINS, Maine MICHAEL F. BENNET, Colorado BILL CASSIDY, M.D., Louisiana SHELDON WHITEHOUSE, Rhode Island TODD YOUNG, Indiana TAMMY BALDWIN, Wisconsin ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts LISA MURKOWSKI, Alaska TIM KAINE, Virginia TIM SCOTT, South Carolina MAGGIE HASSAN, New Hampshire DAVID P. CLEARY, Republican Staff Director LINDSEY WARD SEIDMAN, Republican Deputy Staff Director EVAN SCHATZ, Minority Staff Director JOHN RIGHTER, Minority Deputy Staff Director (II) VerDate Nov 24 2008 14:29 Oct 15, 2018 Jkt 000000 PO 00000 Frm 00002 Fmt 0486 Sfmt 0486 S:\DOCS\25027.TXT CAROL HELPN-004 with DISTILLER CONTENTS STATEMENTS WEDNESDAY, APRIL 5, 2017 Page COMMITTEE MEMBERS Alexander, Hon.
    [Show full text]
  • Sharing, Samples, and Generics: an Antitrust Framework Michael A
    Cornell Law Review Volume 103 Article 1 Issue 1 November 2017 Sharing, Samples, and Generics: an Antitrust Framework Michael A. Carrier Rutgers Law School Follow this and additional works at: https://scholarship.law.cornell.edu/clr Part of the Antitrust and Trade Regulation Commons Recommended Citation Michael A. Carrier, Sharing, Samples, and Generics: an Antitrust Framework, 103 Cornell L. Rev. 1 (2017) Available at: https://scholarship.law.cornell.edu/clr/vol103/iss1/1 This Article is brought to you for free and open access by the Journals at Scholarship@Cornell Law: A Digital Repository. It has been accepted for inclusion in Cornell Law Review by an authorized editor of Scholarship@Cornell Law: A Digital Repository. For more information, please contact [email protected]. \\jciprod01\productn\C\CRN\103-1\CRN101.txt unknown Seq: 1 15-NOV-17 14:39 SHARING, SAMPLES, AND GENERICS: AN ANTITRUST FRAMEWORK Michael A. Carrier† Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies (“REMS”). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug’s risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition.
    [Show full text]
  • Prescription Drug Affordability and Innovation: Addressing Challenges in Today’S Market
    S. HRG. 115–727 PRESCRIPTION DRUG AFFORDABILITY AND INNOVATION: ADDRESSING CHALLENGES IN TODAY’S MARKET HEARING BEFORE THE COMMITTEE ON FINANCE UNITED STATES SENATE ONE HUNDRED FIFTEENTH CONGRESS SECOND SESSION JUNE 26, 2018 ( Printed for the use of the Committee on Finance U.S. GOVERNMENT PUBLISHING OFFICE 38–796—PDF WASHINGTON : 2020 VerDate Sep 11 2014 20:23 Jan 09, 2020 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 R:\DOCS\38796.000 TIM COMMITTEE ON FINANCE ORRIN G. HATCH, Utah, Chairman CHUCK GRASSLEY, Iowa RON WYDEN, Oregon MIKE CRAPO, Idaho DEBBIE STABENOW, Michigan PAT ROBERTS, Kansas MARIA CANTWELL, Washington MICHAEL B. ENZI, Wyoming BILL NELSON, Florida JOHN CORNYN, Texas ROBERT MENENDEZ, New Jersey JOHN THUNE, South Dakota THOMAS R. CARPER, Delaware RICHARD BURR, North Carolina BENJAMIN L. CARDIN, Maryland JOHNNY ISAKSON, Georgia SHERROD BROWN, Ohio ROB PORTMAN, Ohio MICHAEL F. BENNET, Colorado PATRICK J. TOOMEY, Pennsylvania ROBERT P. CASEY, JR., Pennsylvania DEAN HELLER, Nevada MARK R. WARNER, Virginia TIM SCOTT, South Carolina CLAIRE MCCASKILL, Missouri BILL CASSIDY, Louisiana SHELDON WHITEHOUSE, Rhode Island A. JAY KHOSLA, Staff Director JOSHUA SHEINKMAN, Democratic Staff Director (II) VerDate Sep 11 2014 20:23 Jan 09, 2020 Jkt 000000 PO 00000 Frm 00002 Fmt 0486 Sfmt 0486 R:\DOCS\38796.000 TIM C O N T E N T S OPENING STATEMENTS Page Hatch, Hon. Orrin G., a U.S. Senator from Utah, chairman, Committee on Finance .................................................................................................................. 1 Wyden, Hon. Ron, a U.S. Senator from Oregon .................................................... 4 ADMINISTRATION WITNESS Azar, Hon. Alex M., II, Secretary, Department of Health and Human Services, Washington, DC ..................................................................................................
    [Show full text]
  • Congressional Record—Senate S3862
    S3862 CONGRESSIONAL RECORD — SENATE June 14, 2016 sexually transmitted infections (STIs), in their remaining years, and urging generic drugs and biosimilar biological including HIV, and the prevention of the Federal Republic of Germany to re- products; to the Committee on the Ju- dating violence and sexual assault, and affirm its commitment to that goal diciary. for other purposes. through a financial commitment to Mr. LEAHY. Mr. President, in recent S. 2800 comprehensively address the unique months, the high cost of pharma- At the request of Mr. COONS, the health and welfare needs of vulnerable ceutical products has been front and name of the Senator from Georgia (Mr. Holocaust victims, including home center in national news, sometimes ISAKSON) was added as a cosponsor of S. care and other medically prescribed with astonishing examples like the un- 2800, a bill to amend the Internal Rev- needs. conscionable price-hike by Turing enue Code of 1986 and the Higher Edu- S. RES. 349 Pharmaceuticals of their drug for pa- cation Act of 1965 to provide an exclu- At the request of Mr. ROBERTS, the tients with HIV from $13.50 to $750 per sion from income for student loan for- names of the Senator from Kentucky pill overnight. giveness for students who have died or (Mr. MCCONNELL) and the Senator from Pharmaceutical companies should be become disabled. Montana (Mr. DAINES) were added as compensated for their important work cosponsors of S. Res. 349, a resolution developing life-saving treatments, but S. 2856 congratulating the Farm Credit Sys- when companies engage in predatory At the request of Mr.
    [Show full text]
  • Congressional Record United States Th of America PROCEEDINGS and DEBATES of the 116 CONGRESS, FIRST SESSION
    E PL UR UM IB N U U S Congressional Record United States th of America PROCEEDINGS AND DEBATES OF THE 116 CONGRESS, FIRST SESSION Vol. 165 WASHINGTON, WEDNESDAY, MAY 15, 2019 No. 81 House of Representatives The House met at 10 a.m. and was hands of the chief executive officer of The Framers of the Constitution called to order by the Speaker pro tem- the government, in fact, is to prevent a never intended for a President to just pore (Ms. SHALALA). concentration of power in any aspect. totally disregard the Congress. And f There is power that is spread across notwithstanding all that might happen the government. in the courts, notwithstanding all of DESIGNATION OF SPEAKER PRO There are three branches of the gov- the subpoenas that may be taken to TEMPORE ernment. I want to focus this morning, court and have them litigated properly, The SPEAKER pro tempore laid be- if I may, on two—the executive and the the ultimate check on a President is fore the House the following commu- legislative—because, Madam Speaker, Article II, Section 4 of the Constitu- nication from the Speaker: this morning, as I stand before you, a tion, and that is impeachment when he WASHINGTON, DC, proud American, I must inform all that commits impeachable acts. May 15, 2019. the system of checks and balances is at We have the Mueller report. It speaks I hereby appoint the Honorable DONNA E. risk. for itself. And there are many constitu- SHALALA to act as Speaker pro tempore on It is at risk because we now have a tional scholars who have said there has this day.
    [Show full text]
  • Alderson Reporting Company
    HJU120000 PAGE 1 1 ALDERSON COURT REPORTING 2 CHRISTINE ALLEN 3 HJU120000 4 MARKUP OF H.R. 965, THE CREATES ACT; 5 H.R. 2375, THE PRESERVE ACCESS TO AFFORDABLE GENERICS AND 6 BIOSIMILARS ACT; 7 H.R. 2374, THE STOP SIGNIFICANT AND TIME-WASTING ABUSE 8 LIMITING LEGITIMATE INNOVATION OF NEW GENERICS ACT; AND 9 H.R. 2376, THE PRESCRIPTION PRICING FOR PEOPLE ACT OF 2019. 10 Tuesday, April 30, 2019 11 House of Representatives 12 Committee on the Judiciary 13 Washington, D.C. 14 The committee met, pursuant to call, at 2:22 p.m., in 15 Room 2141, Rayburn Office Building, Hon. Jerrold Nadler 16 [chairman of the committee] presiding. 17 Present: Representatives Nadler, Lofgren, Jackson Lee, 18 Cohen, Jeffries, Cicilline, Lieu, Raskin, Demings, Correa, 19 Scanlon, Garcia, Neguse, Stanton, Dean, Murcarsel-Powell, 20 Collins, Sensenbrenner, Chabot, Gohmert, Jordan, Buck, Roby, HJU120000 PAGE 2 21 Johnson of Louisiana, Biggs, McClintock, Reschenthaler, 22 Cline, Armstrong, and Steube. 23 Staff present: David Greengrass, Senior Counsel; Senior 24 Advisor; Lisette Morton, Director of Policy, Planning, and 25 Member Services; Madeline Strasser, Chief Clerk; Moh Sharma, 26 Member Services and Outreach Advisor; Susan Jensen, 27 Parliamentarian/Senior Counsel; Amanda Lewis, ACAL Counsel; 28 Joseph Van Wye, Professional Staff Member, ACAL; Lina Khan, 29 Counsel, ACAL Subcommittee; Slade Bond, Chief Counsel, ACAL; 30 Brendan Belair, Minority Chief of Staff; Robert Parmiter, 31 Minority Deputy Chief of Staff; Jon Ferro, Minority 32 Parliamentarian; Tom Stoll, Minority Chief Counsel, 33 Intellectual Property Subcommittee; Daniel Flores, Minority 34 Chief Counsel, Antitrust Subcommittee; Erica Barker, Minority 35 Chief Clerk; and Andrea Woodard, Minority Professional Staff 36 Member.
    [Show full text]
  • Lobbying, Research & Drugs
    Class 10 – Lobbying, research, drugs Ellen Andrews, PhD Spring 2018 PCH 358 SCSU comparative effectiveness research • New treatments, drugs, devices, procedures largest driver of rising health costs • Little information on which are worth the expense over current care – Half of current treatments unknown effectiveness • Very little science backs up health care treatments • Most Americans believe more is better and are suspicious of CER • Not rationing, will improve health overtreatment • Study of 27,000 treatment recommendations by cardiologists found that only 11% were supported by good science • Expert panel at Harvard reviewed angiograms for patients recommended for bypass surgery, found one in three didn’t need it • Only 20 to 30% of depressed patients are prescribed anti- depressants and one third of those are prescribed the wrong dose • Spine surgery for low back pain performed twice as often in US, six- fold variation across US, often no better or worse outcomes than physical therapy and medications – Among 1500 workers comp back pain cases, those with surgery were out of work 824 more days than those who got therapy and medication, were only 1/3rd as likely to be back at work after two years • Patients with metastatic lung cancer who received early palliative care and less aggressive treatment lived 2.7 months longer than those who received usual oncology care Comparative Effectiveness Research Source: Clinical Evidence, BMJ, January 2013 Drug costs are a priority March Kaiser Foundation 2018 poll of Americans finds: • 52% say
    [Show full text]
  • Rising Drug Costs & Persistent Drug Shortages
    Issue Brief Rising Drug Costs & Persistent Drug Shortages ISSUE SUMMARY Rising pharmaceutical drug costs and an increasing number of drug shortages have had a tremendous impact on the treatment of ophthalmology patients in recent years. Frequent, large, and often unexplained increases in the costs of both brand name and generic prescription drugs for patients are forcing physicians to prescribe alternatives to recommended therapies. Practices have also seen spikes in the cost of the diagnostic drugs they use in their offices. In other instances, commonly-used, inexpensive drugs are suddenly being discontinued or going into shortage, causing disruption to patient care, comprising patient outcomes and leaving ophthalmologists searching for alternative treatments. Request: To increase competition and options for ophthalmic patients, the Academy encourages members of Congress to cosponsor the Creating and Restoring Equal Access to Equivalent Samples Act (S.340/H.R.965). The Academy is also urging Congress to continue working with the Academy and other key stakeholders to identify solutions to drug shortages to ensure patients and physician practices have access to all the treatments that they need. BACKGROUND Drug Pricing: In recent years, the Academy has expressed growing concern over unexpected and spiking costs of both brand name and generic drugs, which are driving up practice expenses and leaving patients with higher out-of-pocket expenses. Ophthalmologists have seen dramatic price increases for commonly used generic drugs that have been low cost for more than a decade. One such example is the ophthalmic preparation of phenylephrine which has increased in cost by 1000% over the past few years.
    [Show full text]
  • Senate Section
    E PL UR UM IB N U U S Congressional Record United States th of America PROCEEDINGS AND DEBATES OF THE 116 CONGRESS, FIRST SESSION Vol. 165 WASHINGTON, WEDNESDAY, APRIL 10, 2019 No. 62 Senate The Senate met at 9:45 a.m. and was Senator from the State of Tennessee, to per- The ACTING PRESIDENT pro tem- called to order by the Honorable MAR- form the duties of the Chair. pore. The clerk will read the bill by SHA BLACKBURN, a Senator from the CHUCK GRASSLEY, title for the second time. State of Tennessee. President pro tempore. The legislative clerk read as follows: Mrs. BLACKBURN thereupon as- f A bill (H.R. 1585) to reauthorize the Vio- sumed the Chair as Acting President lence Against Women Act of 1994, and for PRAYER pro tempore. other purposes. The ACTING PRESIDENT pro tem- The Chaplain, Dr. Barry C. Black, of- Mr. MCCONNELL. In order to place pore. The Senator from Iowa. the bill on the calendar under the pro- fered the following prayer: Mr. GRASSLEY. Madam President, I Let us pray. visions of rule XIV, I object to further ask unanimous consent to speak to the proceedings. God of grace and glory, we bless Your Senate for 1 minute as in morning busi- Holy Name. Give us a hunger and thirst The ACTING PRESIDENT pro tem- ness. pore. Objection having been heard, the for Your righteousness. Lord, we con- The ACTING PRESIDENT pro tem- bill will be placed on the calendar. fess that we often fall short of Your pore. Without objection, it is so or- high standards for living.
    [Show full text]