From the Editor in Chief: An All-or-Nothing Approach Could Tie FDA's Hands - - BioPharm International

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From the Editor in Chief: An All-or-Nothing Approach Could Tie FDA's Hands


BioPharm International
Volume 19, Issue 9


Laura Bush
FDA announced in July that it would develop new guidance to address concerns about potential conflicts of interest among advisory committee members. This action was taken, presumably, to preempt Congress from passing more restrictive rules, particularly those in the Hinchley Bill. Narrowly passed by the House last year, the bill prohibits anyone with a financial stake in the topic under discussion from participating in an FDA advisory committee. While this attempt to prevent bias is admirable, it is also unrealistic.

In debates like this, it is tempting to be a purist and adopt an all-or-nothing approach. However, that can have unexpected consequences.

The plight of Hutcheson Memorial Forest provides an example. Hutcheson, in central New Jersey, is one of few remaining virgin forests in the Eastern United States. For more than two centuries, the family that owned the land resisted the temptation to harvest its valuable timbers. When they finally gave in, around 1955, a small portion was saved for posterity by an unlikely group—a carpenter's union. Passionate about preserving the woods, the group ceded the land to Rutgers University under a deed that prohibits any land management on the property.

That sounded like a good, protective policy—at least for 50 years ago, before commercial and residential overdevelopment led to enormous growth in the deer population. Today, deer thrive on the edge of these woods, with no natural enemies to control their numbers. The deer are decimating the undergrowth at Hutcheson, including all the white oak saplings that should create the next generation of canopy. This allows Japanese stilt grass, an invasive species the deer don't eat, to overtake many areas. But because the rules are so strict, Rutgers cannot do anything to control either the deer or the stilt grass, or any other problem that threatens the future of the forest.

The carpenters, in their quest to save the trees from logging, surely didn't intend to leave the woods vulnerable to other forms of destruction.

Before finalizing any legislation designed to protect FDA from conflicts of interest, Congress should recall Hutcheson Memorial Forest. Yes, it is necessary to manage industry influence at FDA. But legislators should be sure that the rules are not so restrictive that they interfere with FDA's mission to protect the public.

The focus of the current debate is FDA committees involved in evaluating new drugs. But new legislation, if not carefully worded, could also affect the agency's other committees, such as CDER's Advisory Committee for Pharmaceutical Science. This committee, and others like it, provide the agency with invaluable advice about manufacturing. FDA doesn't produce drugs and can never have the level of manufacturing expertise that industry does. For this reason, FDA needs these boards. (FDA should probably hire more folks with industry experience, but it's hard to lure experts away from lucrative industry jobs for life in the public sector.)

Rather than going to extremes, Congress should implement moderate measures, like those in last year's Senate version of the Hinchley law, and in other legislation proposed more recently, such as the Enzi–Kennedy bill. Those measures seek to limit industry influence, not by cutting off FDA's ability to get advice from experts with financial ties to industry, but by revealing the sources of the advice. Such measures can help protect FDA's unbiased role without sacrificing information-gathering, a critical aspect of decision-making.










Laura Bush is the editor in Chief of BioPharm International,

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