Senators Seek Change in FDA's Interest Conflict Rule

A vital amendment is on way. US senators are about to bring change in rule for advisers involve in reviewing new drug approvals. This is because there were lots of cases when FDA could not find experts because of conflicts of interest.

Lawmakers want FDA to loose regulations according to which advisers are not allowed to review new drug application if the respective person is financially associated with manufacturers. Current regulation makes it hard to find experts to be hired on review panel.

FDA is largely funded by fees taken from manufacturer of drug who are seeking FDA approval to make drug available in market. Hence, FDA's funding bill is a way to make major changes in the way FDA work.

Issue was raised by Mike Enzi and Al Franken, senators from Republican and Democratic party respectively.

FDA has to postpone meeting of drug-review committee while finding adviser without any conflicts. Expert doctors are already recruited by manufacturers as consultant and rule prevents FDA to hire same doctor in advisory panel.

FDA in May reported 23% vacant position in advisory panel.

Although FDA is free to avoid recommendations from advisor, it usually follows.

In the wake of Vioxx pain drug controversy, FDA made regulatory changes which restricted appointment of a person with financial ties fearing impact on one's view.

There are currently 10 panelists in FDA advisory panel who were also consulted by drug manufacturers. 9 panelists recommended bringing a drug in market which was called back in 2004.

Hamburg, FDA Commissioner, is also in favour of relaxed rule.