Constitution Center
400 7th St SW
Washington
DC
20024
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 Â鶹´«Ã½ Trade Commission seek public comment from interested parties. In particular, we invite comment on the following questions:
- 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?
- 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?
- 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?
- How do companies assess the benefits, costs, and risks of contracting with intermediaries? How well do consumers understand intermediaries’ roles? Is more information necessary?
- 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, Â鶹´«Ã½ Trade Commission
8:45 am
Keynote Remarks
- The Honorable Maureen K. Ohlhausen
Acting Chairman, Â鶹´«Ã½ 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, Â鶹´«Ã½ 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, Â鶹´«Ã½ 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, Â鶹´«Ã½ 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, Â鶹´«Ã½ Trade Commission
FileAgenda (100.67 KB) - Svetlana S. Gans
- FileSpeakers’ Bios (204.9 KB)
-
Event Materials
FilePresentation Slides (8.86 MB)
-
Videos
-
Location
Request for Comments
The FTC will be accepting public comments through December 8, 2017, one month after the workshop. To submit a comment, go to: . You may also read comments that have already been received.