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FDA Drug Advisers Have Financial Conflict of Interest

In two recent articles on September 25, 2000 by both Reuters News and USA Today came reports that that 54 percent of the experts the FDA asks for advice on which medicines should be approved for sale had a direct financial interest in the drugs or topics they were evaluating. These financial conflicts or interest typically include stock ownership, consulting fees or research grants.

Federal law prohibits the FDA from using experts with financial conflicts of interest, but the FDA has waived the restriction more than 800 times since 1998. Although the FDA does reveal when financial conflicts exist, since 1992 it has kept the details of any conflict secret so it is not possible to determine the amount of money or the drug company involved.

The USA Today article stated, "These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice."

USA TODAY conducted an analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30. The following are listed in the article as their findings:

  • At 92% of the meetings, at least one member had a financial conflict of interest.
  • At 55% of meetings, half or more of the FDA advisers had conflicts of interest.
  • Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts.
  • At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict.
  • Larry Sasich of the advocacy group, "Public Citizen", concluded by saying, "The industry has more influence on the process than people realize."