WASHINGTON _ FDA Commissioner David Kessler,who six months ago resisted any suggestions that hisagency needs reform, in an exclusive interview withBioWorld Today, explained why he met his critics halfway. Kessler spelled out why he struck a deal withleaders of the biotech industry earlier this month toeliminate and standardize several key regulations, addingthat he plans to continue talks about how to implementadditional administrative reforms _ but on his terms.

Kessler described the compromise with the industryunveiled earlier this month (see BioWorld Today, Nov.10, 1995, p. 1) as a "very positive experience to be able toreverse 30 years of regulations in three weeks and to do itin a collegial, cordial, professional and scientific way. Webuilt a lot of bridges."

Kessler said he and his top staff during a three-week timeframe went back and forth with leaders of theBiotechnology Industry Organization (BIO) to nail downways to eliminate burdensome regulations. Their effortsproduced a three-prong initiative that addressed theindustry's fundamental problems with FDA regulation:lot release, establishment license applications (ELA) andcharacterization of a biotech product.

The agreement was elevated to a state ceremony thatfeatured Kessler, leaders of the biotech industry, Sens.Barbara Mikulski (D-Md.) and Edward Kennedy (D-Mass.) standing side-by-side with Vice President AlGore. The agreement was a natural fit for Gore'sgovernment-wide initiative to streamline unnecessaryregulation and paperwork. Kessler's celebration of thisregulatory initiative was in contrast to rumors that hadbeen circulating for months that he was privately resistingGore's attempts to streamline FDA regulation, accordingto industry sources.

But despite the show of good will that day, the industrycontinues to stress the need for legislation to codify andexpand upon those changes. BIO President CarlFeldbaum and other industry leaders have voicedconcerns that the regulatory relief could be turned back ifthe changes are not enacted into law.

But despite his commitment to continue talks with theindustry about eliminating more unnecessary FDAregulations, Kessler shied away from backing theindustry's number one policy goal: enactment of newfederal legislation to streamline FDA regulation. "I'mrelatively neutral on the need for legislation," he said.Kessler sought to ameliorate his neither pro nor conanswer by adding, "I am fully supportive of the[regulatory changes] struck with the biotech industry. Butthe basic issue with the legislation is whether it isreasonable and thoughtful."

He disagreed with those in industry who have said theseregulatory changes now need to be codified. "You don'tneed legislation to get rid of this stuff." (See the article onp. 2 for the latest details on some of those administrativechanges.)

Kessler attributed his new-found conversion to FDAregulatory reform to both Mikulski and Kennedy.Reminded that Mikulski last April publicly scolded himat a Senate hearing for not taking industry's demand forregulatory relief seriously (see BioWorld Today, April 7,1995, p. 1), Kessler admitted that "she was tough" butadded that she "appropriately" raised the issue.

Kessler's attribution of his success to both Kennedy andMikulski are typical of his attempts to strike a politicallymoderate or bipartisan stance in partisan Washington. Hetold BioWorld Today that he served as a staff aide to thenSenate Labor and Human Resources CommitteeChairman Orrin Hatch (R-Utah), noting that "Hatch didnot have the votes in that committee so that anything thatgot through . . . had to be done with the help of Sen.Kennedy." Kessler added, " I had as many friends onKennedy's staff as I did on Hatch's staff."

His Bipartisan Stance Works

Kessler's bipartisan stripe may explain why he has beenable to hold down the job of FDA commissioner for fiveyears, about twice as long as most commissioners haveheld the position in the last 20 years. Kessler noted that arumor "each week" circulates around Washington that heis leaving but he denied any plans to resign.

He is eager to continue a dialog with the biotech industryabout regulatory relief but added, "first I have to bringthis home." FDA has a tight timetable to issue thepertinent implementing regulations within the next 90days.

Kessler gave the industry a lot of credit for changing hismind. "They were very persuasive," he said, referring toBIO Chairman and Genzyme Corp. President HenriTermeer and other board members who presented theirarguments to standardize FDA regulation of biotechdrugs with synthetics.

"They argued that it didn't make any sense to haveproducts in both the Center for Biologics Evaluation andResearch [CBER] and the Center for Drug Evaluationand Research and to be regulated very differently." WhileKessler disagreed that synthetic drugs and biotechproducts should be regulated identically, he agreed thatwell-characterized biotech drugs should be regulatedalike. "They also made a good case for how cumbersomeELAs were," he told BioWorld Today.

The commissioner made it clear that agency officialsalready had anticipated many of the industry's proposals.The agency's on-going commitment to regulatory reformhelped Kessler meet his commitment to forge acompromise in only three weeks, he said.

`The Real Issue Was Trust'

But the culmination of the agreement was nearly lostwhen at the last minute the industry hesitated, not trustingKessler and his staff's intentions. "The real issue wastrust. That was the hardest thing we had to surmount,"Kessler said. "We had to overcome [their reluctance] thatwe were and are very serious about changing theframework to one that makes sense."

But there are a number of regulatory reform issues onwhich Kessler is not committed to compromise.Promotional materials is one of them. Permitting drugcompanies to promote an off-label use of a drug is "theback door way to lower the efficacy standard," he said.

Kessler said he believes that permitting off-label use willprompt drug manufacturers to design clinical trials for a"small well-defined population" and then "promote it toeverybody. That basically eliminates the incentives to dothe study in a rigorous way and bring the results to theagency. A company might say, `I can increase my saleswithout doing the kind of definitive studies I need forFDA approval.' This undercuts . . . the efficacy standard,"he said.

However, Kessler admits to deliberately lowering theefficacy standard when it comes to AIDS drugs. "We areapproving with less information than before. Let's face it.We have lowered our standards for conditional approvals.But we keep to our standards in the confirmatory trials. Iam not going to sit here and tell you that we have notlowered our standards. We are taking greater risks and Ithink it is OK to do that."

Kessler also struck an artful pose on the issue of summarydata. "While conceding that there was "room fordiscussion," with industry he added that "reviewers dofind things by looking at the case records."

And What About Genetic Engineering?

Kessler declined to give his opinion about the less-than-rosy prospects for genetic engineering. "I'll leave that toDr. Varmus," referring to National Institutes of Health(NIH) Director Harold Varmus, who is currentlyreviewing gene therapy research funding from the NIH.

But he said he was proud of efforts by the FDA to definethe central regulatory issues raised by genetic therapy andtransgenic transplantation. He pointed to Phil Noguchi,director of the division of cellular and gene therapieswithin CBER.

"They have asked the right kind of questions and raisedthe right kind of issues," he said. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.