Teleconference Information
Unlocking the Secrets of FDA's Orange Book:
An Introduction to Therapeutic Equivalence, Drug Patents & Exclusivities, and More
A Teleconference Presented by Mr. David Rosen;
Foley & Lardner LLP
Sponsored by FOI Services, Inc. and REEDFAX
Thursday, April 22, 2010; 1:00pm - 2:30pm EDT (GMT -4)
The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, was first published in 1979, and since its introduction has unquestionably been the authoritative reference source for drug products approved by FDA under the Federal Food, Drug & Cosmetic Act.
In 1984, with the passage of the Drug Price Competition Act and Patent Term Restoration Act, FDA's Orange Book took on additional significance -- it was designated as the repository and official source for identifying affected patents and periods of marketing exclusivity associated with referenced products.
No longer a printed book, but a database available on FDA’s website, the Orange Book lists all products that have been approved by FDA for safety and effectiveness, and explains the therapeutic equivalence code for multi-source products.
Professionals in the pharmaceutical industry must have a working understanding of FDA's Orange Book to insure successful navigation of the rigorous FDA approval process and comply with appropriate patent restrictions and marketing exclusivities. With many blockbuster drugs losing patent and exclusivity protection over the years 2010 - 2014, the Orange Book is more important than ever in anticipating the competitive pressures of upcoming generic products.
On Thursday, April 22 at 1:00 pm EDT, join FOI Services, Reedfax and David Rosen for a 90-minute teleconference designed to:
(a) explain the history of the FDA's Orange Book;
(b) review how it is organized and maintained;
(c) provide an understanding of the meaning of therapeutic equivalence codes;
(d) review how and why patents may be affected and define the codes associated with those patents; and
(e) provide an understanding of the provisions of market exclusivity codes associated with products.
Don't miss this valuable chance to gain a thorough understanding and appreciation of the Orange Book -- make sure you can comfortably and confidently use the wealth of information this standard industry reference offers.
What will be covered:
- Why and when FDA's Orange Book was developed
- How to find product information
- What patent information can be listed
- Controversies about listing and delisting patents
- How and when the Orange Book is updated and how to correct inaccurate information
- The meaning of Therapeutic Equivalence codes and how they are used by state Boards of Pharmacy and Pharmacists
- The various types of exclusivity and their impact on product approval
- Practical tips for using this information in product development and approval
What You'll Learn:
- How to easily navigate and understand the contents of the FDA's Orange Book
- Why the book is Orange
- How to mine the Orange Book for the information you need in developing and protecting products
- What to do if you suspect Orange Book information is inaccurate
- Why and when patent information is included in product records
- How to interpret marketing exclusivity information
- Why it is important to monitor the Orange Book regularly
- How the drug approval process and the Orange Book interrelate
What You'll Get:
- A thorough working knowledge of the FDA's Orange Book
- An understanding of why FDA is involved with patent terms
- Practical insight into the importance of the information in the Orange Book
- An understanding and appreciation of the relationship of the NDA and ANDA drug approval process and the Orange Book
- Links to the Orange Book and additional important information
- Links to responsible FDA staff
- Regulatory and legal perspectives
- An experienced and engaging instructor who was a principal author of the FDA's Orange Book and a respected member of the FDA Bar
About Your Presenter:
David Rosen is a partner at the law firm Foley & Lardner, where he chairs the firm's FDA Regulatory Group and co-chairs the Life Sciences Industry Team. He has extensive in health law, life sciences, and food and drug regulation, including a range of FDA regulatory issues affecting prescription and over-the-counter drugs, medical devices and biologics. David was formerly a partner with the two other large law firms, which he joined after 14 years at FDA. At FDA, he progressed rapidly to supervisory positions involving virtually all aspects related to the drug approval process and related compliance activities. He was particularly involved in generic drug products, and was one of the originators of FDA's Orange Book. More information about David Rosen's background and qualifications is available here.
Who Should Attend:
Anyone responsible for, or affected by, FDA pharmaceutical regulations:
- Management
- Legal staff
- Drug patent researchers
- Regulatory affairs personnel
- Product development professionals
- Business development and competitive intelligence staff
- Library and information specialists
How it Works:
Each toll-free (even if international) dial in is $449; put the teleconference on your speakerphone and have as many attendees as you like for this price. REEDFAX will provide a handout 1-2 days before the teleconference. The materials may be duplicated for anyone attending.
