Editor's Viewpoint

Looking forward to 2009
Part I of this FDLI SmartBrief special year-end report looked back at the most important trends and stories of 2008. Part II, below, highlights our predictions and yours -- the FDLI SmartBrief readers -- for what's in store for 2009.

The upcoming year will present many challenges and opportunities in the food and drug law arena. Companies will work to adjust to the regulatory environment under a new, as-yet-unannounced FDA commissioner, while seeking to renew consumer confidence in drug and food safety. Generic drugs, including follow-on biologics, could gain attention as power in the executive branch transitions from President George W. Bush to President-elect Barack Obama. Also, Congress is expected to begin to examine the possibilities for health care reform, reduction in medical costs and food safety regulations, among other important industry topics.

As for FDLI events, 2009 will see several significant conferences held in Washington, D.C., including the 2nd Annual Conference on Nanotechnology Law, Regulation & Policy; the 52nd Annual FDLI & FDA Conference; and the 21st Annual Advertising & Promotion Conference. Visit the FDLI Web site for full details.

Your Predictions

What is the most pressing issue facing the drug industry?

• Drug safety -- 46%
• Drug costs -- 22%
• FDA approval process -- 25%
• Reimbursement -- 7%
  

What is the most pressing issue facing the food and ingredients industry?

• Pathogens in produce and meat -- 39%
• Imports -- 43%
• Melamine and other contaminants -- 12%
• Origin labeling -- 6%

Which legislative/regulatory issue will be most important in 2009?

• Reimbursement of drugs and devices -- 12%
• Monitoring of imported drugs and devices -- 39%
• Drug and device companies' gifts to doctors -- 0%
• Universal health care -- 49%
  

Upcoming Events

Upcoming FDLI conferences and events
New Administration Forecast -- Focusing on Food Safety Legislation, Funding, FDA Initiatives and Pending Nutrition Issues
Dec. 15
Audioconference

Pharmaceutical Risk Management: Practical Applications
Jan. 13, 2009
Washington, D.C.

Introduction to Food Law and Regulation
Jan. 27 to 28, 2009
Washington, D.C.

Introduction to Drug Law and Regulation
Feb. 3 to 4, 2009
Washington, D.C.

2nd Annual Conference on Nanotechnology Law, Regulation & Policy
Feb. 18 to 19, 2009
Washington, D.C.

Introduction to Medical Device Law and Regulation
Feb. 26 to 27, 2009
Washington, D.C.

52nd Annual FDLI & FDA Conference
April 22 to 23, 2009
Washington, D.C.

Introduction to Biotechnology Law and Regulation
May 28 to 29, 2009
Washington, D.C.

Introduction to Drug Law and Regulation
June 25 to 26, 2009
Washington, D.C.

21st Annual Advertising & Promotion Conference
Sept. 22 to 23, 2009
Washington, D.C.

Introduction to Drug Law and Regulation
Nov. 5 to 6, 2009
Washington, D.C.

Introduction to Medical Device Law and Regulation
Nov. 17 to 18, 2009
Washington, D.C.

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