In a Clinton administration health care double-play last Friday,David Kessler was reappointed as head of FDA and BernadineHealy resigned as director of the National Institutes of Health.
Healy, who has been in office less than two years and is thefirst woman to hold that position, will return to the ClevelandClinic Foundation to take up her cardiology practice after June30, when the resignation becomes effective.
Healy's goals and policies were often controversial on The Hill.But Eric Christiansen, head of government relations at theIndustrial Biotechnology Association, praised her performanceon issues of concern to the biotechnology industry.
For one, she recruited Francis Collins, the co-discoverer of thecystic fibrosis gene, to run the National Center for HumanGenome Research. In an arrangement that is unique at NIH,Collins not only will direct the extramural research program,but also will run a laboratory focused on human genetics.
"This program will provide the NIH community with access tothe kinds of genetic analysis, statistical analysis and mappingthat are needed to do disease gene searches," said Leslie Fink,public affairs officer for the genome project.
IBA's Christiansen also praised Healy for the way she dealtwith the issue of patenting of genes or gene fragments by thegovernment. "The NIH's filing for gene patents was an excellentinterim step to protect the domestic and international rights tothe research that NIH is doing," said Christiansen.
"My personal feeling is that Healy is an extraordinarilyqualified, competent person," said Peter Barton Hutt, formerchief counsel to FDA. "In the area of recombinant DNA researchand the human genome project, and things of that nature, shetried very hard to push ahead on the relevant science."
Healy was not afraid to take on controversial issues, to thebenefit of science, said Hutt. "She raised the issue of how tobalance investigator-initiated research with directed research,"and came down on the side of directed research, "picking outareas of national importance and placing greater emphasis" onthem. "I admire her very much for doing that even though Idisagree with her.
"I hope we get an equally capable sound scientist, and frankly,tough thinker, because we are certainly not guaranteedunlimited funding in the future, and issues of this kind willhave to be raised," said Hutt.
Samuel Ronel, president of Interferon Sciences Inc. of NewBrunswick, N.J., and former president of the Association ofBiotechnology Companies, commended Healy for focusing onwomen's health, "an area which science has ignored," butstrongly criticized her for her stand on fetal tissue research,"which I think is very important to the development of newtherapies."
As for Kessler, "We are happy to see him stay on," saidChristiansen. "He was instrumental in developing the FDA userfee system which we believe will be critical in clearing up thebacklog of products awaiting FDA approval. His appointment ofKathy Zoon (to head the Center for Biologics Evaluation andReview) was excellent. We have worked well with Dr. Kessler."
-- David C. Holzman Special to BioWorld
(c) 1997 American Health Consultants. All rights reserved.