The Federal Trade Commission will hold two roundtables on emerging health care competition and consumer issues. They will focus on two distinct areas in which competition and consumer protection policies are implicated: (1) competition among health care providers based on quality information; and (2) competition provided by developing an abbreviated regulatory approval pathway for follow-on biologic drugs.
Competitive Significance of Health Care Quality Information (October 30, 2008)
Competition Issues Involving Follow-on Biologic Drugs (November 21, 2008)
PARTICIPANT'S ARTICLES & PRESENTATIONS: COMPETITIVE ISSUES INVOLVING FOLLOW-ON BIOLOGIC DRUGS
- Rachel Behrman, Follow-on Biologics: A Brief Overview [PDF]
- Ronny Gal, Eight Thoughts On Biosimilars [PDF]
- Paul Heldman, Follow-On Biologic Market: Initial Lessons and Challenges Ahead [PDF]
- Linda Horton, The European Experience With Follow-on Biologics Legislation (Long Version) (Short Version) [PDF]
PARTICIPANT'S ARTICLES & PRESENTATIONS: COMPETITIVE SIGNIFICANCE OF HEALTH CARE QUALITY INFORMATION
- Kristin Madison, Regulating Health Care Quality in an Information Age (UC Davis Law Review) [PDF]
- Clyde Chumbley, Community Leadership in Creating Value-Driven Health Care: The Wisconsin Collaborative for Healthcare Quality [PDF]
- Irene Fraser, Competing on Quality: 6 Barriers to a Healthy Health Care Market [PDF]
- Karen Milgate, Use of Medicare Information to Improve Health Care Delivery [PDF]
- Barbra Rabson, Massachusetts Health Quality Partners Performance Reporting [PDF]
- Peter V. Lee, Employers’ Promoting Competition: Seeking Answers -- Facing Uncertainty [PDF]
- Vincent E. Kerr, Performance Measurement: What the Marketplace Requires [PDF]
The event is free and open to the public. All attendees will be required to display a current driver's license or other valid form of photo identification. FTC Headquarters are accessible to people with disabilities. If you need an accommodation related to a disability, please call Carrie McGlothlin, (202) 326-3388.
Pre-registration for this workshop is not necessary, but is encouraged, so that we may better plan for the event.
To pre-register, email your name and affiliation to firstname.lastname@example.org.
NOTE: When you pre-register, we will collect your name, affiliation, and your email address. This information will be used to estimate how many people will attend. We may use your email address to contact you with information about the workshop.
FILING A COMMENT
The Commission invites interested persons to submit written comments on issues related to this workshop. All comments in response to the Federal Register Notice [PDF] are due by September 30, 2008. In addition, any interested person may submit written comments to any of the topics addressed during the workshops. Comments directed at a particular subject considered in a workshop or roundtable must be submitted not later than 30 days after the date of that workshop or roundtable.
Comments should be captioned “Emerging Health Care Competition and Consumer Issues – Comment, Project No. P083901” and be submitted according to the instructions below.
To File Electronically:
Comments filed in electronic form should be submitted by using the following weblink: http://secure.commentworks.com/ftc-healthcarecompetition and following the instructions on the web-based form.
To File in Paper Form:
Include “Emerging Health Care Competition and Consumer Issues – Comment, Project No. P083901” both in the text and on the envelope, and mail or deliver to the following address:
Federal Trade Commission/Office of the Secretary
600 Pennsylvania Avenue, N.W.
Room H-135 (Annex F)
Washington, DC 20580
Because postal mail in the Washington area and at the Commission is subject to delay, please consider submitting your comments in electronic form, as prescribed above. The FTC requests that you send any comment by courier or overnight service, if possible.
To Request Confidential Treatment:
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with Commission Rule 4.9(c). Comments should not include any sensitive personal information, such as an individual’s Social Security Number; date of birth; driver’s license number or other state identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records and other individually identifiable health information.
Comments received will be available to the public on the FTC website, to the extent practicable, at http://www.ftc.gov/os/publiccomments.htm.
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.
FOR FURTHER INFORMATION
For questions related to the workshop, contact:
Bureau of Competition,
600 Pennsylvania Avenue, N.W.,
Washington, D.C. 20580
Phone (202) 326-2435