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Event Description

The Hatch-Waxman Act, passed by Congress more than 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has succeeded in lowering patent-related barriers to generic drug entry, thereby spurring additional competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act. Concern about rising drug prices has caused policymakers to question whether there are obstacles to generic entry that prevent competition from keeping prices in check.

The first session explored generic drug markets, including considerations that may preclude entry after relevant patents have expired. Panelists will discuss price and non-price factors that may influence entry in these markets. The second session evaluated intermediaries in the pharmaceutical supply chain, focusing on pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs). Panelists discussed how the contractual relationships between intermediaries, manufacturers and health plan sponsors ultimately affect the prices consumers pay for prescription drugs. Throughout the day, speakers discussed means to encourage entry and eliminate competitive impediments in prescription drug markets.

To aid our analysis of these issues and various proposals intended to address them, the staff of the Federal Trade Commission seek public comment from interested parties. In particular, we invite comment on the following questions:

  1. Do generic drug manufacturers have sufficient incentives to enter markets where the brand drug is off-patent? Do policymakers or market participants have a role in providing incentives to encourage entry decisions that better align with the public interest?
  1. Some report strategies to reduce generic drug competition when the branded drug is off-patent. Are these reports accurate? If so, what steps are taken to reduce competition? If not, are there other reasons why generic entry is not seen as robust? What can be done?
  1. What role do intermediaries, such as pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) play in prescription drug pricing, consumer access, and quality? What are the benefits and costs of intermediaries in the pharmaceutical supply chain? Has consolidation affected price, access, or quality?
  1. How do companies assess the benefits, costs, and risks of contracting with intermediaries? How well do consumers understand intermediaries’ roles? Is more information necessary?
  1. How should stakeholders evaluate proposals to reduce drug prices and increase consumer access in prescription drug markets? What role can the FTC play in addressing these issues?

ATTENDING THE WORKSHOP

The workshop was held at the Constitution Center, 400 7th Street, SW, Washington, DC 20024. The workshop was free and open to the public.

The workshop was webcast live.

  • 8:00 am

    Registration

    8:35 am

     

    Introductory Remarks

    • Svetlana S. Gans
      Chief of Staff, Federal Trade Commission

    8:45 am

     

    Keynote Remarks

    • The Honorable Maureen K. Ohlhausen
      Acting Chairman, Federal Trade Commission
    • The Honorable Scott Gottlieb, M.D.
      Commissioner, U.S. Food and Drug Administration

    9:15 am

    Panel 1: Generic Drug Competition: Understanding Demand, Price and Supply Issues

    Panelists:

    • Michael A. Carrier
      Distinguished Professor, Rutgers Law School
    • Chester “Chip” Davis, Jr.
      President and Chief Executive Officer, Association for Accessible Medicines
    • Aharon (Ronny) Gal, Ph.D.
      Senior Vice President and Senior Research Analyst, Sanford Bernstein
    • Aaron S. Kesselheim, M.D., J.D., M.P.H.
      Associate Professor of Medicine at Harvard Medical School, Director, Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital
    • Stephen W. Schondelmeyer, Pharm.D, Ph.D.
      Professor and Head, Department of Pharmaceutical Care and Health Systems, University of Minnesota

    Panel Moderators:

    • Suzanne Munck
      Deputy Director, Office of Policy Planning, Federal Trade Commission
    • Maarika Kimbrell
      Deputy Chief of Staff, Office of the Commissioner, U.S. Food and Drug Administration

    10:45 am

    Break

    11:00 am

    Panel 2: Understanding Intermediaries: Pharmacy Benefit Managers

    Panelists:

    • Rob Andrews
      CEO, Health Transformation Alliance
    • Jennifer Bryant
      Senior Vice President, Policy and Research, PhRMA
    • Adam J. Fein, Ph.D.
      President, Pembroke Consulting, Inc.
    • Mark Merritt
      President and CEO, Pharmaceutical Care Management Association
    • Susan Pilch
      Vice President, Policy and Regulatory Affairs, National Community Pharmacy Association
    • Neeraj Sood, Ph.D.
      Professor and Vice Dean for Research, Sol Price School of Public Policy, University of Southern California

    Panel Moderator:

    • David R. Schmidt, Ph.D.
      Assistant Director, Office of Applied Research and Outreach, Bureau of Economics, Federal Trade Commission

    12:45 pm

    Lunch (on your own)

    2:00 pm

    Panel 3: Understanding Intermediaries: Group Purchasing Organizations

    Panelists:

    • Anthony Barrueta
      Senior Vice President, Government Relations, Kaiser Foundation Health Plan, Inc.
    • Todd Ebert, R.Ph.
      President and CEO, Healthcare Supply Chain Association
    • Erin R. Fox, Pharm.D
      Senior Director, Drug Information and Support Services, University of Utah Health
    • Hal Singer, Ph.D.
      Principal, Economists Incorporated
    • Stephanie Trunk
      Partner, Arent Fox LLP

    Panel Moderator:

    • Markus Meier
      Acting Deputy Director , Bureau of Competition, Federal Trade Commission

    3:30 pm

    Break

    3:45 pm

    Discussion: Potential Next Steps to Encourage Entry and Expand Access through Lower Prices

    Speakers:

    • Rena Conti, Ph.D.
      Assistant Professor, Departments of Pediatrics and Public Health Services, University of Chicago
    • David Mitchell
      Co-Founder and President, Patients for Affordable Drugs

    4:15 pm

    Closing Remarks

    • Suzanne Munck
      Deputy Director, Office of Policy Planning, Federal Trade Commission

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Under the Freedom of Information Act (“FOIA”) or other laws, we may be required to disclose to outside organizations the information you provide when you pre-register. The Commission will consider all timely and responsive public comments, whether filed in paper or electronic form, and as a matter of discretion, we make every effort to remove home contact information for individuals from the public comments before posting them on the FTC website.

The FTC Act and other laws we administer permit the collection of your pre-registration contact information and the comments you file to consider and use in this proceeding as appropriate. For additional information, including routine uses permitted by the Privacy Act, see the Commission’s comprehensive Privacy Policy.

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