By Lisa Seachrist

Washington Editor

WASHINGTON — When the Senate Labor and Human Resources Committee meets Wednesday to consider the nomination of Jane Henney to head the FDA, the highlight of the proceedings is likely to be a discussion of last year's Food and Drug Administration Modernization Act (FDAMA).

Having steered the measure to almost unanimous support, committee Chairman Sen. Jim Jeffords (R-Vt.) wants to ensure that whoever takes up the post that has been vacant since former commissioner David Kessler left in February 1997 is committed to implementing those reforms.

Judging from the responses to 140 written questions that Clinton administration nominee Henney submitted to the committee last week, industry sources say early indications are that Jeffords is satisfied with Henney's willingness to implement FDAMA. As a result, some industry lobbyists are anticipating a relatively smooth confirmation process.

A committee spokesman also pointed to a cooled-down atmosphere concerning the FDA compared to a few years ago when Kessler was at the helm.

"If this nomination doesn't attract a lot of attention, it is possible that she could be confirmed before the Senate adjourns," the spokesman said. "The position of FDA commissioner doesn't create the emotional response it once did."

The first step for Henney, currently vice president of health sciences at the University of New Mexico, in Albuquerque, is Wednesday's committee hearing. Following the hearing, the committee could take an "off-the-floor" vote on recommending her to the entire Senate. Majority Leader Trent Lott (R-Miss.) may choose to entertain floor debate on the nominee or simply put her nomination to a vote at the end of business.

FDAMA Commitment BIO's No. 1 Concern

Regardless of her route to a confirmation vote, tomorrow's hearing and Henney's responses will be closely watched by FDA-regulated industries.

"First and foremost, we are concerned with the nominee's commitment to FDAMA," said Alan Goldhammer, executive director of technical affairs for the Biotechnology Industry Organization (BIO). "We are certainly going to be paying attention to all of her answers during the hearing."

While calling the vast majority of Henney's responses to the committee's questions reasonable, BIO found four responses the organization said needed more discussion and clarification from the nominee.

BIO wants a more detailed answer concerning clinical trials needed to support an indication that has already become the standard of care.

For example, Henney, an oncologist, is familiar with having a regimen of chemotherapy as the accepted treatment for combating a particular cancer even though the regimen has never received FDA approval for treating that cancer. During the FDAMA negotiations last year, Goldhammer pointed out that improving the supplemental application process was the subject of "a great deal of discussion."

"We don't believe that a placebo-controlled clinical trial is relevant in this situation," Goldhammer said. "We would like to see Henney discuss what standards are to be used."

In addition to supplemental applications, BIO has concerns over how Henney would interpret the "substantial evidence" needed to grant a full approval to a product that has received a fast-track approval based on a surrogate endpoint.

Policies On Generic Biologics Hazy

The fact that biologics can be regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) raised additional questions, Goldhammer noted. First, advisory committees for the two centers function quite differently. All divisions in CBER, for instance, allow sponsors to review the briefing documents provided to the advisory committee to ensure that the information is accurate and up to date. This practice varies widely between divisions at CDER.

BIO wants Henney to offer more explanation to her response concerning the harmonization of advisory committees. "We'd really like to see her discuss how the FDA and sponsors interact will the committees and the role and usefulness of advisory panels in general," Goldhammer said.

Goldhammer also pointed to Henney's response concerning setting up a generic drug program for biologicals. Currently, there is no specific provision in the law permitting generic biologicals, and Henney indicated that she had no intention of establishing a generic approval system for biological products.

However, because some biologics are regulated by CDER, it is unclear whether generic forms of these drugs could be approved under the current abbreviated application system used for drugs. Goldhammer said BIO maintains there is insufficient science supporting a move to a generic system for biologics.

"Just because you can express a protein doesn't mean it is biologically active," Goldhammer said. "We think that you have to establish this with clinical trials. We would like to know where she believes the science is today." *