By Lisa Seachrist

Washington Editor

WASHINGTON ¿ With increasingly complex drug and biologics applications to review, the FDA is faced with reviewing products with which it has little experience or expertise.

In response, the agency is searching for ways to strengthen the scientific basis by which it decides whether a product comes to market, and has asked for suggestions from stakeholders. The Biotechnology Industry Organization (BIO) proposed that the agency might achieve that end though improved use of its advisory committee system.

¿We think that there are too many drugs going to committee,¿ said Allan Goldhammer, director of technical affairs at BIO. ¿It¿s an important resource, and there could be some improvements in how the agency makes use of that resource.¿

Unfortunately, many drug sponsors see the process of presenting their products to the advisory panels as fraught with capricious pitfalls.

In a letter to the FDA, BIO suggested the agency establish on every advisory panel an ad hoc member who has clinical experience with the product being reviewed. In addition, BIO called on the agency to send a product to an advisory panel only when there are complex scientific issues that need to be addressed, and to enhance the consistency of review by keeping the sponsor well informed about the meeting agenda.

BIO suggested the benefit of a non-voting, ad hoc member who would participate in questioning both the sponsors and the FDA reviewers presenting at the panel hearing, as well as contribute to the discussion the panel members have following the presentation.

Currently, sponsors often include clinicians in their presentations, but they don¿t serve on the advisory panel.

¿When you are talking about scientific issues with a product, hearing from someone who has worked with it in the clinic would provide meaningful input to the committee¿s discussion,¿ Goldhammer said. ¿They would be prevented from voting on the product by conflict-of-interest concerns, but they would still provide unique experience with the product.¿

BIO also is recommending that the agency provide more consistency for the advisory panel process. The agency has no standard operating procedure establishing whether it can provide amendments to the package the panel reviews. As a result, sponsors sometimes are caught by surprise with the questions that are the focus of the committee meeting.

Instead, BIO proposed that the FDA develop an agency-wide standard that would provide all amendments to both committee members and the sponsors prior to the hearing.

¿If something is going to the advisory committee, the sponsors need to prepare,¿ Goldhammer said. ¿Last-minute surprises aren¿t fair to either the sponsors or the committee.¿

With the crush of products coming to advisory committees, BIO is concerned the agency will have difficulty convincing qualified scientists to serve on the committees. BIO maintains that too often these panel hearings simply provide a rubber stamp for decisions that the agency already has made. Instead, BIO called for the FDA to require advisory committee meetings only for products that present significant scientific issues on which the agency truly needs advice.

¿If the idea is to identify some critical scientific questions, then a panel hearing is appropriate,¿ Goldhammer said. ¿But we don¿t think the advisory committees should be used as a routine affirmation of FDA¿s review.¿ n