On October 27, 2005, from 1:00 - 2:00 pm EDT, Peter Barton Hutt, senior counsel at the law firm of Covington and Burling, will discuss the current regulatory climate and its effect on the pharmaceutical and medical device industries. He will share his perspective on:

• The effect that each Commissioner has on the daily operations of the FDA,
• What to do when FDA seems reluctant to take any action on a product application,
• How to appeal an adverse decision,
• How to deal with a hostile investigator or reviewer,
• The effect that Congress, the press, and patient groups have on agency decisions,
• The regulatory risk of off-label promotions, and
• The effect that the "new" risk management initiative will have on FDA in 2006.

Peter Barton Hutt is senior counsel at the law firm of Covington & Burling and has been an advisor to FDA and industry officials since 1971 when he served as the agency's chief counsel. He was named by The Washingtonian magazine as one of Washington's 50 best lawyers (out of more than 40,000) and, as one of Washington's 100 most influential people, by the National Law Journal; as one the 40 best health care lawyers in the United States; and by European Counsel as the best FDA regulatory specialist in Washington, D.C. Business Week recently referred to Mr. Hutt in June 2003 as the "unofficial dean of Washington food and drug lawyers."

It is a live event that includes an interactive question and answer period, and access for an unlimited number of participants at each call-in site. However, only one site can be offered per registration. It is impermissible for an organization to purchase one registration and to operate multiple sites through an internal telephone system. During the live Audioconference participants will be able to ask questions and make comments. The Audioconference faculty has agreed to take follow-up questions via email. Pharma Summit Audioconferences are simple, accessible, cost effective and reach a broad audience locally.

Pharmaceutical and Medical Device Health Care Executives and Board Members, Healthcare Compliance Professionals, Health Plan, Health System and Physician Organization Medical Directors, Physicians, Pharmacists, Purchasers, including Private Employers and Public Manufacturers, Generic Pharmaceutical Manufacturers, Site Management Organizations, Clinical Research Organizations, Pharmacy Benefit Management Companies, Health Plans and Health Insurers , Wholesale, Retail, Mail Order and Internet Pharmacies, Health Care Attorneys and In-house Counsel, Compliance Officers, Privacy Officers, Ethics Officers, Food and Drug Law Attorneys, Pharmaceutical and Medical Device Consultants, Investment Bankers, Venture Capitalists, Health Care Regulators and Policy Makers, Health Services Researchers and Academics, Health Care Auditors.

All Faculty Materials will be Posted on the Pharma Audioconference website: www.PharmaAudioconferences.com/pcaudio20051027 in downloadable PDF Formats.