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FDA Tightens Limits On Expert Drug Advisers

Posted by Jenny Albano
Thursday, August 07, 2008 12:50 PM EST
Category: Major Medical, Protecting Your Family
Tags: Conflict-of-Interest, FDA and Prescription Drugs, Drug Makers, Drug Products, Vioxx

Advisers have new financial guidelines





In order to reduce apparent conflicts-of-interest, the Food and Drug Administration (FDA) announced Monday that members of the advisory committee that recommend the approval of drugs for the FDA must abide by new financial limits.

Appointments to this advisory committee have recently come under fire from Congress and watchdog groups after the withdrawal of the painkiller Vioxx in 2004.

In 2006, the consumer group Public Citizen completed a study that found that in 73% of the advisory committee meetings from 2001 to 2004, at least one member of the group had a financial tie to the drug company that was seeking approval of its new medicine. Some of the voting members' grants or consulting fees exceeded $100,000.

Advisory committee members are often the world's leading experts on a particular disease or condition. Because of this, drug and device makers frequently pay them high consulting and speaking fees, but these financial interests also can lead to a conflict-of-interest.

The appearance of being impartial is tainted when drug experts are also on the receiving end of tens of thousands of dollars in grants or consulting fees.

Because of the publics’ reaction and new congressional requirements, the FDA has created four guidance documents that are meant to limit bias from committee members and to let the public view committee procedures.

According to Randall Lutter, Ph.D., deputy commissioner for policy, “The FDA’s regulatory decisions affect the health of millions of Americans, and we don’t make those decisions in a vacuum. It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent. Today’s announcement strengthens our processes.”

The new financial guidelines state that prior to each meeting the members of the committee will be screened to find out whether they have a potential conflict-of-interest with the drug or device makers they are voting on. Members who have a financial interest that is greater than $50,000 in any company that is being voted on in that meeting will not be allowed to participate.

Advisers that have stocks, grants, or other financial ties that are less than $50,000 may be allowed to participate in meetings and vote if the FDA deems their expertise necessary. To do this the FDA would grant a waiver which would include a description of the adviser’s financial interest and why his or her expertise is essential. All this information will be available to the public on the FDA’s website prior to the meeting.

Dr. Sidney Wolfe, director of Public Citizen health research group, stated that the new regulations are weaker than the guidelines the FDA had released more than a year ago. Under the old proposal, advisers who had a financial interest of less than $50,000 would be allowed to attend meetings, but would be unable to vote. Wolfe believes that the FDA changed the proposal because the agency does not want to expend the energy to find experts that don’t have a conflict-of-interest.

FDA senior policy adviser Jill Warner said the agency has been trying to recruit independent experts, but finding advisers without any ties to the industry is difficult. She stated that the new guidelines are more strict than required by current law and advisers would be disqualified from participating on a committee under certain conditions, even if their financial stake did not surpass $50,000.

Committee members would be ruled out if, for example, they served as principal investigators on a clinical trial of the product submitted to FDA for approval or if they led a clinical trial on a competing product.

The FDA also announced several other policy changes on Monday. The recommended that advisory board members vote all at one time, rather than one at a time and that all votes be announced immediately at the meeting. Votes will now be detailed on the FDA’s website for public viewing.

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