Advisory Committees

Linda Ann Sherman, MD, MPAAdvisory Committee Oversight and Management

Staff, DirectorU.S. Food and Drug Administration

April 20, 2005

Welcome!to the Washington Area!

FDA’ s Mission

To promote the public health by promptly and

efficiently reviewing clinical research and

taking appropriate action on the marketing of

regulated products in a timely manner

Most Americans Recognize FDAWhat is the name of the government agency that conducts the review and approval of new drugs and devices before they can be put on the market in this country?

5%

25%

70%

FDAOtherDon't know

Source: Aggregate Spring 1999

Charleton Research Company

U.S. Food and Drug Administration

FDA regulates over $1 trillion worth of products, which accounts for 22 cents of every dollar spent annually by American consumers.

Public Expectations

The Public trusts the FDA, as a public service agency, to safeguard their health and safety by making timely and credible independent scientific judgments on food and health products.

FDA Strategies to Address those Expectations

• Have a Strong Science Base– to support regulatory decisions

• Exercise Risk Management– before and after products enter the marketplace

• Provide Effective Risk Communication– to stakeholders

FDA’s Responsibilities Remain for the Product’s Entire Lifecycle.

FDA - Strong Science for a Healthy World

Commercialization UseDiscovery &Development

PremarketReview

Close to 10,000 Persons Work at FDA

• Physicians & Nurses• Microbiologists• Chemists• Pharmacists• Toxicologists• Statisticians• Biopharmaceutists• Engineers• Economists• Support Staff

FDA is composed of six Centersand the Office of the Commissioner and Office of Regulatory Affairs

Center for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Drug Evaluation and ResearchCenter for Food Safety and Applied NutritionCenter for Veterinary Medicine National Center for Toxicological Research

FDA’s Acting CommissionerLester Crawford, DVM, PhD

• Deputy Commissioner of Policy (Acting)– Vacant

• Deputy Commissioner for Operations (Acting)– Janet Woodcock

• Deputy Commissioner for Special Programs (Acting)– Murray Lumpkin

Commissioner’s Office

• Office of Management– Kathleen Heuer

• Office of External Relations – Sheila Dearybury Walcoff

• Office of Policy– Randall Lutter

• Office of Legislation– Patrick Ronan

• Office of Science – Norris Alderson

• Office of the Chief Counsel– Gerald Masoudi

Center Directors

• CBER – Jesse Goodman, MD• CDER – Steve Galson, MD (Acting)• CVM - Steve Sundlof, DVM, PhD• CFSAN – Robert Brackett, PhD• CDRH – Daniel Schultz, MD• NCTR - Dan Casciano, PhD• ORA – John Taylor, JD

What do we really do?What do we really do?Ensure that medical products

are safe and effective

WhatWhat do we do we notnot do? do?Dictate medical practice or service

FDA Hot Topics

• Counter-terrorism• Ephedra• Mercury in Fish• Cox-2 Inhibitors• Influenza Vaccine• Importation of Drugs• Breast Implants• Obesity

The Review Process

• Original IND, IDE• IND, IDE, Submissions• Adverse Events Profile• NDA, ANDA, PLA, ELA, BLA, PMA, 510K• Annual Reports• Labeling Changes and Supplements• Single Investigator IND

Reviewing is a Team Approach

Review Team Members

• Project Manager• Biopharmaceutist• Microbiologist• Chemist• Medical Officer• Statistician• Toxicologist

Levels of Review• Primary

– Detailed data review– Recommends additional information, if needed– Initial recommendation for action

• Secondary– Works with primary reviewer – edits,

challenges– Prepares a secondary review

• Tertiary– Final action

The Value of an Advisory Committee

• Provides independent expert advice• Lends credibility to the product review

process• Allows for a public discussion of controversial

issues• Keeps consumers abreast of trends in

product development• Assists in external review of FDA’s intramural research programs

Two Types of Advisory Committees

• Statutory– Required by law

• Discretionary– Deemed necessary by the

Agency

Department Policy on Committee Establishment

• No Federal advisory committee will be established unless such establishment is specifically authorized by statute, by the President or by the Secretary.

• Discretionary committees will be established only after the Secretary has determined in consultation with GSA and OMB, where required that the specific functions and duties cannot be adequately performed by existing HHS offices, by informal working relationships within or between departments or agencies of the Federal Government, or by existing Federal advisory committees.

Establishment Process

• FDA can request establishment of a new committee when:

– There is a genuine need for advice from an advisory committee and it is in the public interest to establish such a committee

and– Agency officials have ensured that adequate

authority exists for such establishment and the authority complies with statutory requirements and restrictions.

Termination of a Committee

For Advisory Committees whose duration is not otherwise fixed by law or Presidential Directive will terminate:

– Two years after establishment unless approved for renewal in consultation with General Services Administration or

– When its mission has been accomplished even though the expected period of duration has not expired or

– When the function can be easily assigned to another committee.

Department of Health &Human Services Objectives

• Limit the number of advisory committees to those that are essential and terminate any committee not fulfilling its purpose

• Assure adequate opportunities for access by the public to advisory committee meetings

• Provide clear goals … assure that committees are used solely for advisory functions unless provided otherwise by statute

Advisory Committees are Product and/or Center Related

There are

Center for Biological Evaluation and

Research

Allergenic ProductsCellular, Tissue and Gene Therapies Blood ProductsTransmissible Spongioform

EncephalopathiesVaccines and Related Biological Products

Center for Drug Evaluation and Research

• Anesthetic & Life Support Drugs

• Anti-Infective Drugs• Anti-Viral Drugs• Arthritis Drugs• Cardiovascular & Renal

Drugs• Dermatologic & Ophthalmic

Drugs• Drug Abuse Endocrinologic

& Metabolic Drugs• Gastrointestinal Drugs

• Non-Prescription Drugs• Oncologic Drugs• Peripheral & Central

Nervous System Drugs• Pharmaceutical Science• Psychopharmacologic

Drugs• Pulmonary-Allergy Drugs• Reproductive Health Drugs

Center for Devices and Radiological Health

• National Mammography Quality Assurance*• Device Good Manufacturing Practice*• Technical Electronic Product Radiation Safety Standards

Committee*• Medical Devices*

*(Statutory Committees)

Center for Devices and Radiological Health • Medical Devices’

Panels*– Anesthesiology and

Respiratory Therapy Devices– Circulatory System Devices– Clinical Chemistry and

Clinical Toxicology Devices– Dental Products– Ear, Nose and Throat Devices– Gastroenterology and Urology

Devices– General and Plastic Surgery

Devices– General Hospital and Personal

Use Devices– Hematology and Pathology

Devices

– Immunology Devices– Microbiology Devices– Neurological Devices– Obstetrics and

Gynecology Devices– Ophthalmic Devices – Orthopedic and

Rehabilitation Devices– Radiological Devices– Dispute Resolution– Molecular and Clinical

Genetics

Center for Food Safety and Applied

Nutrition

Food Advisory Committee

Center for Veterinary Medicine

Veterinary Medicine Advisory Committee

National Center for Toxicological Research

• Science Advisory Board• Advisory Committee on Special Studies Relating to the

Possible Long-Term Health Effects Phenoxy- Herbicides and Contaminants (Ranch Hand)**

** Chartered and Members appointed by Secretary HHS

Office of the Commissioner

Science Board of the

Pediatrics Advisory Committee**Statutory

Types of Topics

Brought Before an Advisory Committee

• Review of Cutting Edge Scientific Issues• Product Approval Issues• Adverse Event Problems• Labeling Issues• Guidance Documents• Peer Review of Intramural Research

Who Comprises the Membership?

•Our Stakeholders:– Academicians– Clinicians– Consumers– Industry Representatives– Patients and/or Patient Care Givers

FDA Aims for a Diverse Advisory Forum

• FDA wants to have its Advisory Committee members mirror the population of America with regard to – age – race– sex– ethnicity– geographic location

Who Can Recommend a Prospective Member?

• Referrals come from:– Former/Current Advisory Committee Members– FDA Scientists– Professional Societies and Journals– Academic Institutions– Consumer Groups– Self Nominations– Congressional Staff– Industry

Member Selection(Varies Somewhat by Member Type)

• Public (Federal Register) notice requests Nominations

• Résumés reviewed by Product Related area within the Agency and recommendation forwarded to the Appointing Official– Screen for Needed Expertise– Preliminary Screen for Conflicts of Interest

• Consideration is made for Committee Balance• A letter of invitation is extended by the

Associate Commissioner for External Relations

Committee Service

• Term of Service is usually Four (4) years (service is extended only rarely)

• Most “standing” Members become special Government employees (SGEs)

• SGEs are subject to Conflict of Interest (COI) Screening and the Emolument Clause of the U.S. Constitution

• A Chair is usually selected after experience as a Committee Member

Conflicts of Interest

Prior to every Meeting each (SGE) member is evaluated for any potential conflicts of interest relative to the meeting topic

Conflict of Interest Dilemma

• Experts by definition are engaged in cutting edge bench science, “clinical trial” research and independent consulting work.

• By virtue of the above, these individuals are sought out by regulated industry to assist in product development.

Meeting Logistics

• Briefing Packages sent at least 3 weeks in advance to the Advisory Committee Members

• Redacted Briefing Packages available for review on the Web and as handouts at the time of the Meeting

• Conflict of Interest Disclosure Statements Read into the Record

• Chair - Facilitates the Meeting• Questions presented to the Committee Discussed

and Voted Upon• Open Public Hearing (public comment) available at

each meeting

Who Can Vote?

• NOT EVERYONE• Statute

Dependent

– COI limitations– Industry Reps– Consumer Reps– Patients

An Important Take Home Message

• Advice from Advisory Committees is thoroughly reviewed by the FDA Scientific Staff

• However, decisions and votes are NOT binding on the Agency.

Finally…

Questions(?):

Advisory Committee Oversight and Management StaffU.S. Food and Drug Administration5600 Fishers Lane (HF-4)Rockville, Maryland 20857301-827-1220lsherman@oc.fda.gov

Or

Internet http://www.fda.gov/oc/advisory/default.htm