Background
The Medicare Modernization Act (MMA) of 2003 eliminated many of the techniques that original drug manufacturers employed to protect their franchises from generic competition. However, there was one major brand-preservation avenue - the use of authorized generics (AGs) - that the MMA did not touch. As a result, AGs have become the favored strategy for defending branded drug sales from generic encroachment in recent years and, in the process, AGs have arisen as one of the most controversial issues in the US pharmaceutical industry.

To date, efforts by regulators and the generic industry to combat Authorized Generics have been largely unsuccessful. With the new Democratic-controlled Congress and a federal budget increasingly burdened by pharmaceutical expenditures, that may change in the near future.

Todd Clark
Throughout his career, Todd Clark has worked extensively in healthcare marketing, consulting, consumer goods and technology. His focus for the last ten years has been on the healthcare industry. Since founding VOI Consulting in 1998, he has worked with a range of clients to develop successful valuation, commercialization, marketing and competitive strategies for both US and international efforts. Areas of specialization include market analysis, marketing strategy, business development, regulatory compliance and finance. Todd is the author of the GenericHandbook and PharmaHandbook: A Guide to the International Pharmaceutical Industry an annual publication which provides decision-makers with information on the healthcare business and regulatory environments in over 35 global pharmaceutical markets. He has published in Pharmaceutical Executive and has been quoted as an expert in other industry trade press.

• Define authorized generics
• Impact of new Democratic Congress -- review of some anti-AG legislation under consideration, its likelihood of passage and implementation
• Discuss legislation to allow lower-cost follow-ons of biotechnology drugs while protecting intellectual property and innovation
• Patent Challenges -- summary of recent court decisions on authorized generics, recent out-of-court settlements, etc.
• Would a ban on AGs may actually benefit the branded drug industry while hurting generic manufacturers

Additional Resources

• GenericHandbook