ROCKVILLE, Maryland—The April 12 Food and Drug Administration (FDA) Arthritis Advisory Committee meeting to consider approval of Merck's Arcoxia® (etoricoxib) might be the last one before it and other advisory committees are roiled by application of the FDA's proposed tough new conflict-of-interest rules.¹

The proposed change, called a "draft guidance," limits to $50,000 the financial interest a person can hold in any entity likely to gain or lose as a result of government action on a particular topic, and includes:

• stock ownership (except for diversified mutual funds, unit investment trusts, sector mutual funds, and total securities interests in affected entities less than $15,000)
  
• research funding, and
  
• consulting arrangements

The draft guidance applies not only to the potential advisory committee member but also to a spouse, minor children, business partners, prospective employers, and any organization in which the member serves as an officer, director, trustee, employee, or general partner. In addition, the $50,000 limit applies not only to current financial holdings or relationships but also to those in the previous 12-month period. It will be indexed for inflation according to increases in the Consumer Price Index.

"Affected organization" refers to any company or entity that could be affected by the advisory committee proceedings, including the sponsor of a new drug application before the committee or of "drugs that closely compete with the subject drug."

The multistep vetting process is illustrated in the algorithm [Figure, click to enlarge image].