fda to speed approval of biotechnology drugs

1
NEWS OF THE WEEK meter waves (microwaves) radiating at the specific frequencies of water vapor, chlorine monoxide, and ozone to obtain a better understanding of their distribu- tion through the upper atmosphere. Several of the ATLAS-1 instruments will fly on future ATLAS missions, slat- ed to launch at about one-year intervals. ATLAS-2 is scheduled for spring 1993. Beyond its own science mission, a key goal of the ATLAS series is to calibrate NASA's Upper Atmosphere Research Satellite, launched last September. Richard Seltzer FDA to speed approval of biotechnology drugs In an effort to speed up approval of an expected onslaught of new biotechnol- ogy drugs, David A. Kessler, commis- sioner of the Food & Drug Administra- tion, has announced the hiring of 50 new reviewers and the appointment of a new director for the center responsi- ble for approving such drugs. Kessler's move comes on the heels of the Bush Administration's issuance of a new policy for regulating biotechnolo- gy (C&EN, March 2, page 5). As Kessler recently told the Massachusetts Biotechnology Council: "FDA recog- nizes the value and enormous potential of biotechnology. ... We will insist on high standards, but FDA will not be a bottleneck in the development of these new products/ 7 A first sign of FDA's position is Kessler's appointment of Ph.D. biochem- ist Kathryn C. Zoon to head the Center for Biologies Evaluation & Research. Zoon has been at FDA since 1980. And Kessler points out that she not only is "an eminent scientist," but also "an ex- perienced FDA regulator with critical knowledge about the agency and the workings of the center." Since 1988, Zoon has directed the center's division of cytokine biology. This division carries out research in cell biology and cellular and molecular immunology. Before going to FDA, Zoon was a postdoctoral fellow at the National Insti- tutes of Health, working with chemist and Nobel Laureate Christian B. Anfin- sen. Their joint project was the purifica- tion of human interferon alpha, one of the first biotechnology-derived products. Industry spokesmen highly praise Zoon's appointment. Says Thomas L. Copmann, Pharmaceutical Manufac- turers Association assistant vice presi- dent for biotechnology, "She is an ener- getic individual, well-liked, and an out- standing scientist who makes decisions on sound scientific principles." Kessler also is giving Zoon 50 new re- viewers to boost the 200 or so already dealing with biotechnology drugs. FDA is not receiving any additional funds for these positions, but will pay for them out of current appropriations. However, an FDA spokesman can't say how this will affect other programs. Zoon says she will use the new positions "to opti- mize and streamline our review pro- cess." The Industrial Biotechnology Associa- tion (IBA) is very pleased by the in- creased number of reviewers, despite the lack of additional FDA funding. Alan R. Goldhammer, IBA director of technical affairs, believes it will help keep FDA on track. It will prevent the agency from getting behind as more and more bio- technology products come up for review and approval, he says. According to FDA, 15 biotechnology drugs have been approved in the past nine years. Last year, it approved only two, both cytokines. Twenty-one others now await review and approval. If the past is prologue, Copmann calculates, "it will take FDA 13 years just to take care of these 21." But of even more concern to industry are the 300 biotech- nological products now in clinical trials that at some point will reach FDA. Lois Ember Long-term technology, science strategy urged The House Committee on Science, Space & Technology, or at least its Democratic members, has taken the opportunity presented by the end of the Cold War to lay out a strategic, long-term vision for civilian science and technology. What the committee is aiming for, says its chairman, Rep. George E. Brown Jr. (D.- Calif.), is a coordinated national technol- ogy policy to stimulate economic growth and creation of high-technology jobs. Basically, the plan—outlined in the committee's annual report to the House Budget Committee discussing R&D spending during the coming fiscal year (1993)—calls for an orderly, phased, and planned transfer of funding from de- fense R&D accounts to civilian R&D. These transfers would total about $2 bil- lion in fiscal 1993, and about $14 billion over five years. They would be applied immediately to civilian investments in technology and education designed to enhance U.S. industrial competitiveness. The report calls for funding the $2 billion transfer by denying the $1.1 bil- lion increase proposed by the Adminis- tration for the Strategic Defense Initia- tive, and by taking $900 million out of the Department of Energy's weapons research, development, testing, and evaluation budget. From the 1993 transfer, the commit- tee's Democrats would provide addi- tional funding for a number of Depart- ment of Commerce initiatives. These include $100 million for advanced tech- nology programs, $60 million for in- dustry-government consortia working on advancing critical technologies, $50 million for manufacturing technology centers, and startup funding of $20 mil- lion for a low-cost federal commercial- ization loan program. For the National Science Foundation, the committee would provide a total of $150 million for academic facilities, up from $16.5 million this year, and an ad- ditional $25 million for the engineering research centers program. However, for any of these transfers to occur, the "fire wall" erected between defense and civilian spending accounts by the 1990 budget act would have to be breached. Committee Democrats argue it should be breached. Recent funding debates that pit civilian R&D and its "big science" projects against veterans housing, water projects, and environ- mental programs should be replaced, the report says, by a debate that focuses on the rate and extent to which civilian R&D should replace military R&D in the federal budget. However, others in Congress strongly believe the wall should not be breached, saying any defense savings should be applied to deficit reduction. Committee Republicans don't want to breach the wall, either. In a separate section of the report, they agree with the Democrats on the need to increase "real" federal investments in civilian R&D contributing to economic growth. However, they would fund the in- crease by cutting back other civilian R&D spending, such as a new space launch system. Janice Long 6 MARCH 16,1992 C&EN

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Page 1: FDA to speed approval of biotechnology drugs

NEWS OF THE WEEK

meter waves (microwaves) radiating at the specific frequencies of water vapor, chlorine monoxide, and ozone to obtain a better understanding of their distribu­tion through the upper atmosphere.

Several of the ATLAS-1 instruments will fly on future ATLAS missions, slat­ed to launch at about one-year intervals. ATLAS-2 is scheduled for spring 1993. Beyond its own science mission, a key goal of the ATLAS series is to calibrate NASA's Upper Atmosphere Research Satellite, launched last September.

Richard Seltzer

FDA to speed approval of biotechnology drugs In an effort to speed up approval of an expected onslaught of new biotechnol­ogy drugs, David A. Kessler, commis­sioner of the Food & Drug Administra­tion, has announced the hiring of 50 new reviewers and the appointment of a new director for the center responsi­ble for approving such drugs.

Kessler's move comes on the heels of the Bush Administration's issuance of a new policy for regulating biotechnolo­gy (C&EN, March 2, page 5). As Kessler recently told the Massachusetts Biotechnology Council: "FDA recog­nizes the value and enormous potential of biotechnology. . . . We will insist on high standards, but FDA will not be a bottleneck in the development of these new products/7

A first sign of FDA's position is Kessler's appointment of Ph.D. biochem­ist Kathryn C. Zoon to head the Center for Biologies Evaluation & Research. Zoon has been at FDA since 1980. And Kessler points out that she not only is "an eminent scientist," but also "an ex­perienced FDA regulator with critical knowledge about the agency and the workings of the center." Since 1988, Zoon has directed the center's division of cytokine biology. This division carries out research in cell biology and cellular and molecular immunology.

Before going to FDA, Zoon was a postdoctoral fellow at the National Insti­tutes of Health, working with chemist and Nobel Laureate Christian B. Anfin-sen. Their joint project was the purifica­tion of human interferon alpha, one of the first biotechnology-derived products.

Industry spokesmen highly praise Zoon's appointment. Says Thomas L.

Copmann, Pharmaceutical Manufac­turers Association assistant vice presi­dent for biotechnology, "She is an ener­getic individual, well-liked, and an out­standing scientist who makes decisions on sound scientific principles."

Kessler also is giving Zoon 50 new re­viewers to boost the 200 or so already dealing with biotechnology drugs. FDA is not receiving any additional funds for these positions, but will pay for them out of current appropriations. However, an FDA spokesman can't say how this will affect other programs. Zoon says she will use the new positions "to opti­mize and streamline our review pro­cess."

The Industrial Biotechnology Associa­tion (IBA) is very pleased by the in­creased number of reviewers, despite the lack of additional FDA funding. Alan R. Goldhammer, IBA director of technical affairs, believes it will help keep FDA on track. It will prevent the agency from getting behind as more and more bio­technology products come up for review and approval, he says.

According to FDA, 15 biotechnology drugs have been approved in the past nine years. Last year, it approved only two, both cytokines. Twenty-one others now await review and approval. If the past is prologue, Copmann calculates, "it will take FDA 13 years just to take care of these 21." But of even more concern to industry are the 300 biotech-nological products now in clinical trials that at some point will reach FDA.

Lois Ember

Long-term technology, science strategy urged The House Committee on Science, Space & Technology, or at least its Democratic members, has taken the opportunity presented by the end of the Cold War to lay out a strategic, long-term vision for civilian science and technology. What the committee is aiming for, says its chairman, Rep. George E. Brown Jr. (D.­Calif.), is a coordinated national technol­ogy policy to stimulate economic growth and creation of high-technology jobs.

Basically, the plan—outlined in the committee's annual report to the House Budget Committee discussing R&D spending during the coming fiscal year (1993)—calls for an orderly, phased, and planned transfer of funding from de­

fense R&D accounts to civilian R&D. These transfers would total about $2 bil­lion in fiscal 1993, and about $14 billion over five years. They would be applied immediately to civilian investments in technology and education designed to enhance U.S. industrial competitiveness.

The report calls for funding the $2 billion transfer by denying the $1.1 bil­lion increase proposed by the Adminis­tration for the Strategic Defense Initia­tive, and by taking $900 million out of the Department of Energy's weapons research, development, testing, and evaluation budget.

From the 1993 transfer, the commit­tee's Democrats would provide addi­tional funding for a number of Depart­ment of Commerce initiatives. These include $100 million for advanced tech­nology programs, $60 million for in­dustry-government consortia working on advancing critical technologies, $50 million for manufacturing technology centers, and startup funding of $20 mil­lion for a low-cost federal commercial­ization loan program.

For the National Science Foundation, the committee would provide a total of $150 million for academic facilities, up from $16.5 million this year, and an ad­ditional $25 million for the engineering research centers program.

However, for any of these transfers to occur, the "fire wall" erected between defense and civilian spending accounts by the 1990 budget act would have to be breached. Committee Democrats argue it should be breached. Recent funding debates that pit civilian R&D and its "big science" projects against veterans housing, water projects, and environ­mental programs should be replaced, the report says, by a debate that focuses on the rate and extent to which civilian R&D should replace military R&D in the federal budget.

However, others in Congress strongly believe the wall should not be breached, saying any defense savings should be applied to deficit reduction.

Committee Republicans don't want to breach the wall, either. In a separate section of the report, they agree with the Democrats on the need to increase "real" federal investments in civilian R&D contributing to economic growth. However, they would fund the in­crease by cutting back other civilian R&D spending, such as a new space launch system.

Janice Long

6 MARCH 16,1992 C&EN