발간보고서
home > 자료실> 발간보고서
- 글자크기
U.S. Food and Drug Administration Advisory Committee(FDA AC)
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2015-05-12 | 조회수 | 1,243 |
| 원문 | |||
| 출처 | |||
U.S. Food and Drug Administration
Advisory Committee (FDA AC)
경력사항
- 2011~現 Health Research International 대표
- 現 한국보건산업진흥원 GPKOL 위원(임상, R&D기획 분야)
학력사항
- 1973-1976 위스콘신 의과대학(University of Wisconsin Medical School),
약리학 박사 후 과정 - 1970-1973 오하이오 주립대 의과대학, 약리학 박사
- 글 이희민
Advisory Committees
From the U.S. FDA Advisory Committee Home Page
Prepared by
Heemin (Herman) Rhee, Ph.D., President
Health Research International
11320 Coral Gables Drive
North Potomac, MD 20878, U.S.A.
1. Introduction:
The FDA supports the pharmaceutical industry at every step of the process of drug discovery, development and global marketing, which are achieved by regulatory scientific innovation and the independent recommendations from the effective Advisory Committees (ACs) operation. Indeed, the FDA approved 41 new molecular entities (NMEs) from the final 42 NDA applications in 2014. In 2005, the FDA approved only 20 NMEs from the 39 applications. The U.S. Pharmaceutical industry represents over 40 percent of global markets, which is important not only for the provision of the safe, effective and quality medicines to our citizens, but also for the U.S. National economy.
Korean government also has recognized that the pharmaceutical industry is one of vital and critical businesses for the future of Korean economic growth. The U.S. public and Congress regularly show interest in the AC’s recommendations for the final drug approvals of the first-in-class pharmaceuticals, especially the screening for conflicts of interest and the use of waivers for some conflicts. Although the FDA does not have to accept the recommendations from the ACs, the agency has taken a variety of steps to increase transparency and predictability through the ACs. In this report, the functional role of FDA AC, nomination and qualification of the FDA AC members will be briefly summarized.
2. The Purpose and Function of the FDA AC for the FDA’s Mission:
FDA's ACs provide independent expert advice to the agency on a range of complex scientific, technical, and policy issues, including questions related to the development and evaluation of products regulated by FDA. ACs typically communicate advice or recommendations to the FDA in two ways: First, the FDA learns from the discussion and exchange that occur among AC members’ public hearings, and from individual recommendations and suggestions made during the discussion of any AC meeting. Second, ACs often vote on a question or series of questions posed to the committee during a committee meeting. The FDA subsequently considers the recommendations made by ACs, including the AC deliberations and voting results. There are some AC meetings at which votes are not taken. For example, votes are typically not taken at meetings to discuss the development of a clinical trial design or the development of a guidance document.
At other AC meetings, members cast a formal vote on issues related to the approvability of a product submission. In others, different questions may be posed to a committee for a formal vote. Votes can be an effective means of communicating with FDA because they provide feedback on discrete questions such as drug approval. These questions are generally scientific in nature and can involve a range of subjects, including evaluation of post-market safety data or pre-market assessment of a product's risk/benefit profile. Since all members vote on the same question, the results help FDA gauge a committee’s collective view on complex, multi-faceted issues. FDA recognizes that many of the questions voted on by AC members are complex, but important for the development of innovative FDA health policy.
3. Public Conduct During FDA Advisory Committee Meetings:
The FDA would like to ensure that advisory committee meetings proceed in an orderly fashion, are conducted in a safe and secure environment, that the right of free speech is protected, and that the ability of FDA Advisory Committees and Panels to accomplish their objectives is not disrupted. Therefore, the following procedures will be observed.
An interested person who wishes to be assured of the right to make an oral presentation during the Open Public Hearing portion of an advisory committee meeting should register with FDA before the meeting. Those who have not registered before the meeting will only be invited to speak at the discretion of the Chair, and should submit their request to FDA officials at the registration desk on the day of the meeting. Open Public Hearing participants who are designated to speak may be questioned only by the Chair or other members of the Committee.
Audience members may not present comments or questions to the Committee unless recognized by the Chair. Attendees may be subject to security screening, such as presenting identification, passing through metal detectors, and inspection of briefcases, packages, etc.
Attendees at the meeting are asked to maintain order and not display behavior that is disruptive to the meeting. The committee Chair or Designated Federal Officer will note on the record any disruptive behavior and will ask the person to cease the behavior or else leave the meeting room.
4. List of Current U.S. FDA ACs:
Currently the FDA has 50 ACs and Panels for the Center of Biologics and Evaluation and Research (CBER), the Center of Drug Evaluation and Research (CDER) and the Center of Device Radiological Health (CDRH) including the Center for Food Safety and Applied and Nutrition (CFSAN), Pediatric, Radiation-Emitting Products, Risk Communication, Science Board to the FDA, Toxicology Research, and Tobacco Products Scientific AC. The Veterinary Medicine Advisory Committee was terminated on September 24, 2013. Due to space limit, only ACs under CBER and CDER are listed below.
- CBER ACs are:
- Blood, Vaccines and Other Biologics (CBER)
- Allergenic Products Advisory Committee.
- Blood Products Advisory Committee
- Cellular, Transmissible Spongiform Encephalopathies Advisory Committee
- Tissue and Gene Therapies Advisory Committee
- Vaccines and Related Biological Products Advisory Committee
- CDER ACs are:
- Anesthetic and analgesic drug product AC
- Anti-infective drugs AC
- Antiviral drugs AC
- Arthritis AC
- Bone, reproductive and urologic drugs AC
- Cardiovascular and renal drugs AC
- Dermatologic and renal drugs AC
- Drug safety and risk management AC
- Endocrinologic and metabolic drugs AC
- Gastrointestinal drugs AC
- Medical imaging drugs AC
- Nonprescription drugs AC
- Oncologic drugs AC
- Peripheral and central nervous system drugs AC
- Pharmaceutical science and clinical pharmacology AC
- Psychopharmacologic drugs AC
- Pulmonary, allergy drugs AC*
- *All FDA advisory committees such as CDER/CBER ACs make regular public notices for their activities that require rather a large space to describe.
5. FDA AC Membership Types and Members’ Qualification:
Scientific members of FDA public advisory committees must be technically qualified experts in their field (e.g., clinical medicine, engineering, biological and physical sciences, biostatistics, and food sciences) and have experience interpreting complex data. Candidates must be able to analyze detailed scientific data and understand its public health significance.
An academician/practitioner uses his or her expert knowledge to provide advice on issues under deliberation at the FDA, and may serve as a Scientific/Technical Member, Ex-Officio Member, Patient Family Representative, Pediatric Health Organization Representative, Health Professional Representative, Government Representative, or a General Public Representative on an FDA Advisory Committee.
Consumer Representative must be able to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of products under review. It is also essential that the representative have an affiliation with and/or active participation in consumer or community-based organizations. The role of the Consumer Representative is to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers.
Industry Representatives are non-voting members. Industry Representatives on the Tobacco Products Scientific Advisory Committee serve in three different roles that include a Tobacco Manufacturing Representative, Tobacco Manufacturing Small Business Representative, and Tobacco Grower Interest Representative.
The FDA is committed to making more opportunities for patients to participate in FDA decision-making, of which program brings the patient voice to the discussions about new and already approved drugs and devices and policy questions. Patient Representatives provide FDA with the unique perspective of patients and family members affected by a serious or life-threatening disease. Patient Representatives provide FDA with the unique perspective of patients and family members affected by a serious or life-threatening disease. On ACs we will offer the patient perspective, ask questions, and give comments to assist the committee in making recommendations.
Over the years, there has been interest in the potential relationship between AC members’ financial, professional, or personal stakes in AC recommendations and their voting behavior at such meetings. In 2006, the relationship between disclosure of financial conflicts-of-interest and voting behavior among FDA AC members was published. One significant finding of the study was that even if voting committee members with financial conflicts-of-interest had been excluded from voting, none of the voting outcomes for the 76 product meetings analyzed would have changed. Nevertheless, the reporters found a weak, but statistically significant positive relationship between certain types of conflicts and voting patterns in two different analyses that assessed the effects of disclosure on individual votes.
6. Application for FDA AC Membership:
As part of FDA’s ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA ACs, FDA is requesting nominations for members to serve on its ACs. Any interested person may nominate one or more qualified persons for one or more of the ACs or advisory panels. Self-nominations are also accepted. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its ACs and, therefore, encourages nominations of appropriately qualified candidates from these groups.
FDA Advisory committee contact: Office of Commissioner-Advisory Committee Oversight and Management Staff Food and Drug Administration 10903 New Hampshire Avenue WO32 – 5129 Silver Spring, MD 20993-0002, U.S.A. 301-443-0572 or 1-800-741-8138
7. Summary and Conclusions:
U.S. laws and regulations allow the FDA to utilize an advisory committee system to perform its mission of scientific integrity and transparency. Advisory committees (ACs) provide FDA with independent opinions from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food. First-of-a kind, first-in-class human medical products usually need to have an open public hearing (OPH) during the FDA AC meetings. Advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be added for individual committee meetings as needed. Introductions on convening AC meeting, participation process of OPH and voting procedures were described including the AC membership types, requirements and qualification and membership application procedure and conflicts of interest. In this report, FDA’s ACs and its panels are also listed by the FDA individual centers such as CBER and CDER, respectively.
- 끝 -
- 이전글 이전글이 없습니다.
- 다음글 다음글이 없습니다.
