Food and Drug Administration Advisory Committees (1992) / Chapter Skim
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3 The FDA Advisory Committee System
3 The FDA Advisory Committee System
Pages 70-99
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From page 70... ...
The discussion in this chapter is frequently organized around the three different categories of medical technologie~that is, drugs, biologics, and devices. The Drug Evaluation Process When, after in vitro testing and animal studies of toxicity, a new chemical entity appears promising enough to consider clinical trials in humans, the sponsor must notify the FDA of its intention to conduct such trials.)
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From page 71... ...
The data from all three phases, but particularly those from Phase III, form the basis for the FDA's decision on approval, including its specification of indications and other parts of the official label. The FDA issued proposed regulations in April 1992 for the accelerated approval of drugs for serious or life-threatening illnesses (57 Federal Regrsmr 13234, April 15, 1992~.
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From page 72... ...
Biologics, however, are regulated under a regime based on the Public Health Service Act of 1944 rather than the Food, Drug, and Cosmetics Act. Although the evaluation process parallels the drug evaluation process, manufacturers submit a product license application (PLA)
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From page 73... ...
A quantitative indication of the work of the three centers is presented in the following tables. Table 3-1 indicates the number and type of submissions or applications that were received by CDER for the years 1986 Medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or to introduce, or reintroduce, a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected....
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From page 74... ...
74 FDA ADVISORY COMM1ITEES Sew ~0 15 10 CDER CBER CDRH [ FY 1~ .| 2~.m 1 2~813 1 12~1 1 Figure ~1 Fiscal year 1992 operating budgets for CDER, CBER, and CDRH. Source: FDA/CDER/CBER/CDRH.
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From page 75... ...
applications have consistently run above 5,000 each year, indicating the high volume of medical device submissions that claim "substantial equivalence" to a pre-1976 device. Table 3~ indicates the stream of CDER approvals during the years 1986 through 1991.
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Center for Dewces and Radiologic Health (CORM Advisory Committees Medical Devices (10/27/90) Anesthesiology and Respiratory Therapy Devices Panel Circulatory System Devices Panel Clinical Chemistry and Clinical Toxicology Devices Panel conimued
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From page 83... ...
Nearly all CDER and CBER advisory committees have been rechartered by the Commissioner following the chartering of a single CDRH Medical Devices Advisory Committee with 16 panels. If a committee has not yet been rechartered, reference is made to "new charter in process." Prior charters were signed by the Secretary; new charters are signed by the Commissioner.
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From page 84... ...
The increased number of advisory committee meetings is shown in Figure 3-5, which indicates more than a 50 percent increase from 1988 to 1991 for CDER, stability, for CBER, and a decrease for CDRH.
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From page 85... ...
THE FDA ADVISORY COMMll -l HE SYSTEM SEW 150 100 lo 1~ 1~0 CDER ~1S1 167 17S C8ER ~27 S1 ~ CDRH 01 ~101 112 117 1 -- -- - ..
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86 FDA ADVISORY COMMll -1 YES AS 30 25 20 10 i Hi ~ NN~ N~ ~ , NNNx ~ ;~N' ~ `, ~ ~ ~ ~E ~ _ ~ ~ ~ ~ 1SB8 1 ~1~ 1981 CDER 1~ 21 28 1 34 CBER ~ 7 J 8 1 7 1 CDRH ~ | ~l Figure 3-5 Number of advisory committee meetings per year for CDER, CBER, and CDRH. Source: Annual Report, FDA/OCJCMO.
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From page 87... ...
Part 14, "Public Hearing Before a Public Advisory Committee," deals with general provisions, meeting procedures, establishment of advisory committees, records of meetings and hearings before advisory committees, members of advisory committees, standing advisory committees, the Technical Electronic Products Radiation Safety Standards Committee, color additive advisory committees, and advisory committees for human prescription drugs. At this time, the two bureaus on drugs and biologics were merged.
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From page 88... ...
to help the agency staff stay current with "state-of-the art technology" by encouraging close working relationships between the staff and outside experts. Advisory committee meetings, it also noted, "serve an important function by providing a public forum for discussion of issues." The preamble also stated that advisory committees "generally" advise the Commissioner on the Safety and effectiveness and regulatory control of human prescription drugs," including "whether the available information is adequate to support a determination that a particular drug meets the statutory standards for proof of safety and effectiveness necessary for marketing approval." At the FDA's request, such committees review "certain critical studies or critical elements of studies on drug products under consideration and labeling issuesn; they also respond to specific FDA questions that ask them to identify The adequate and well controlled studies which demonstrate effectiveness, the seriousness of certain adverse effects, and whether additional studies or data are necessary before a decision can be reached.
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From page 89... ...
system should be to help the agency make sound decisions based upon the reasoned application of good science. Medical Dence Statutes In the case of medical devices, the law requires the use of advisory committees.
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From page 90... ...
In addition, the charges to the Biological Response Modifiers Advisory Committee and the Vaccines and Related Biological Products Advisory Committee require them to consider Appropriate use," and those to the Allergenic Products Advisory Committee and the Blood and Blood Products Advisory Cbmmittee to consider labeling Sues. Yet the scope of CBER advisory committees extends beyond these functions in one important respect, in which they differ from CDER and CDRH committees.
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From page 91... ...
In 1990, the CDRH formally terminated its existing advisory committees, established a single Medical Devices Advisory Committee, and reconstituted the previous committees as 16 Panels of the new committee. The center did so to enable it to bring needed expertise to bear on a given product review and to meet the requirement for a quorum of voting members more easily.
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From page 92... ...
THE USES OF ADVISORY COMMIflLEES The above discussion indicates the range of official purposes of FDA advisor committees in the area of drugs, biologics, and medical devices. Not surprisingly, then, the agency-or, more accurately, its program units_uses such committees in a number of different wayse These variations derive from the following sources: the three separate centers~heir histories, technical and regulatory responsibilities, workloads, and their organizational "culturesn; · the stage of product development and evaluation Relicensing, licensing, postmarketing approval; · the means by which the centers seek external advice advisory committees, Special Government Employee (SGE)
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From page 93... ...
The CDER advisory committee system that developed is organized along the lines of therapeutic agents or product lines, from an industry perspective, as indicated in Table 3-7. This organization parallels the drug evaluation units of the center-the two Offices of Drug Evaluation and their respective divisions, the Pilot Drug Evaluation Office, the Office of Generic Drugs, and the Office of Over-the-Counter Drugs.
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From page 94... ...
One feature that differs between the CDRH and CDER, however, is that executive secretaries and division directors play different roles in product evaluation. The CDRH executive secretary is typically a medical review officer to whom additional executive secretarial functions have been assigned, whereas the division director may be mainly a manager.
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From page 95... ...
The PMA workload that advisory committees now face is substantial and growing; rechartering of multiple advisory committees into a single committee with multiple panels presumably has made this workload easier to manage. The law requires the sponsor of a Class III device marketed before the 19 76 amendments to submit a PMA application when the agency calls for safety and effectiveness data on all devices in that category.
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From page 96... ...
The CDER uses consultants, some of whom are advisory committee members and some of whom are not, throughout the drug evaluation process. For example, it may bring an advisory committee member, as a consultant, into an End of Phase II Conference" with a drug sponsor.
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From page 97... ...
SUMMARY The FDA advisory committee system has been an integral part of the product evaluation process for drugs, biologics, and medical devices. The agency has made increasing use of these committees over time.
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From page 98... ...
Advisory committees are not the only ways by which FDA seeks external expert advice. The agency also makes use of consultants and workshops.
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From page 99... ...
THE FDA ADVISORY COMMl1-l HE SYSTEM 99 9. Food and Drug Administration, "Charter, Medical Devices Advisory Committee," (Washington, D.C., October 27, 1990~.
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