_ FROM THE ARCHIVES:
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FDA Action Handbook

by
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Jim Eigo
Mark Harrington
Margaret McCarthy
Stephen Spinella
Rick Sugden

9-12-88

 

 


October 11, 1988 -- ACT UP, joined by the national ACT.NOW coalition, shuts down the FDA outside of Washington, DC. This historical demonstration against the FDA condemns the lethargy of this dysfunctional bureaucracy which is responsible for the testing and approval of possible AIDS treatments. __

TABLE OF CONTENTS

Introduction: WHY THE FDA?

I. WHAT IS THE FDA?
The Federal Health Bureaucracy

___Who's Involved with AIDS
___The NIH and AIDS
___AIDS & the FDA
___FDA: Who Does What
A Brief History of the FDA
___Elixir of Sulfanilamide
___The "Golden Age" of Pharmaceuticals
___Thalidomide
___The Kefauver Amendment
The FDA and Drug Companies:
___Incest and Competition
___The Orphan Drug Act

II. HOW THE FDA CONTROLS ACCESS TO AIDS DRUGS
The Standard Drug Approval Process:
___Clinical Trials: Phase I, II and III
___Protocols, IRB's and Informed Consent
Extraordinary Release:
___Treatment IND
___Compassionate Use IND
___Money
___Post-Marketing Surveillance and De-Regulation:
___Combined Phases II-III and a new Phase IV?
The Underground Market

III. DRUG HORROR STORIES: HOW THE FDA BETRAYED IT'S TRUST
___& INTENSIFIED THE AIDS CRISIS
Pentamidine Wars
Trimetrexate: Treatment IND Hoax
Imreg-1: Treatment IND Omission
DHPG: Bad Oversight Delays Sight-Saving Drug
IVIG: A Pernicious Placebo
Exclusion of Women, People of Color, Poor People,
___People in Rural Areas, IV Drug Users, Hemophiliacs,
___Prisoners & Children from Drug Trials
FDA & Discrimination in Drug Trials
The Rights of Drug Trials Subjects:
___Drug Trials are Health Care Too
ATR: AIDS Treatment Registries, Local & National

IV. APPENDIX
Federal Drug Law Timeline

Federal AIDS Bureaucracies
AIDS Drug Development Flowchart

..

Introduction: WHY THE FDA?

AIDS activists are disgusted with the entire Federal response to the AIDS crisis; we are disgusted with the inadequate state and local responses as well. Why, then, is the culmination of ACT-NOW's 4 days in the Washington area the Sit-In and Takeover at the FDA?

Many Federal agencies, not to mention local and state ones, have been derelict in the fight on AIDS. The NIH clinical trials are inaccessible to much of the country. CDC epidemiology has lagged throughout the epidemic and perpetuates the invisibility of many groups affected by the disease.

Yet only one agency, the FDA, is actively blocking the delivery of promising drugs to PWAs and people with HIV infection. Other agencies sin by omission; they aren't doing enough. Only the FDA sins by commission; it is doing the wrong things, and they are deadly wrongs. And only the FDA has the power under existing laws and regulations to change direction and provide many of our demands immediately.

Over the weekend of October 8th-9th we will be in Washington to organize a grass-roots, national anti-AIDS mobilization at ACT-NOW meetings and teach-ins. On Monday, October 10th, we will demonstrate at the Department of Health and Human Services under the banner Health Care Is A Right.

Our action stems from the recognition that, in the case of AIDS, from now on, A Drug Trial Is Health Care Too. The FDA says it exists to protect consumers. Well, people with HIV are consumers too, and they need to be protected from a deadly disease. Since so few treatments are approved for AIDS and it's opportunistic infections, the drug trials presently underway are often the only treatments available for PWA's. The imperatives of science, law, bureaucracy and corporate property, which result in 8-10 year testing periods for most drugs, must yield to a synthesis with the needs of seropositives and PWA's who, untreated, will often live far less long.

The FDA, which in the past has protected the public by blocking unproven drugs, must now protect it by speeding promising ones for life-threatening conditions. Admiral James Watkins, Chairman of the President's Commission on the HIV Epidemic, spoke publicly of the shame he felt for his country upon viewing FDA facilities. Besides money and personnel, the FDA's new mission requires it to have the power and the will to compel reluctant drug sponsors to release experimental treatments (or lose the rights to the drug) and trial sponsors to design humane trials. Because for a large and growing number of Americans, the area of the medial establishment directly controlled by the FDA is about to become their health care system. And health care, as activists know, is a right.
-- Jim Eigo
-- Mark Harrington

PART 1:
WHAT IS THE FDA?

The US Food & Drug Administration (FDA) is a Federal regulatory agency. It is part of the Department of Health and Human Services (HHS) branch known as the Public Health Service (PHS). Other agencies dealing with AIDS, such as the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) are also part of the PHS.

THE FEDERAL HEALTH BUREAUCRACY: WHO'S INVOLVED WITH AIDS?

AIDS activists must understand the Federal health bureaucracy in order to force it to respond to the treatment needs of people infected with HIV. The Federal AIDS establishment is almost entirely centered within the Department of Health and Human Services (HHS). Dr. Otis Bowen is the Secretary of HHS and heads the Department. Within the HHS, two departments are relevant to AIDS. Dr. William Ropper heads the Health Care Financing Administration (HCFA). Responsibility for the development and regulation of new drugs lies within the Public Health Service (PHS). Dr. Robert E. Windom, Assistant Secretary of Health , heads the PHS. Dr. Peter Fischinger is the PHS AIDS Coordinator. The PHS comprises a number of huge agencies critically involved in AIDS drug and vaccine development. These are the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and, to a lesser extent, the Centers for Disease Control (CDC), responsible for tracking the spread of the disease, and the Alcohol, Drug Abuse & Mental Health Association (ADAMHA), conducting some research into the neurological implications of AIDS. Dr. James Wyngaarden is Director of NIH: Dr. Frank Young is Commissioner of Food & Drug; Dr. James Mason is Director of CDC; Dr. Donald McDonald is Director of ADAMHA. (JE/Iris Long)

THE NIH AND AIDS

Federal biomedical research directed towards finding a cure for AIDS takes place mainly in the NIH. It is made up of 12 research institutes. Most AIDS research is carried out at 2 of these institutes, the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases (NIAID).

NIAID is the focal point of AIDS research because AIDS is a disease caused by an infectious agent, HIV (Human Immunodeficiency Virus). NIAID, under the direction of Dr. Anthony Fauci (who is also NIH AIDS Coordinator and chairs it AIDS Executive Committee) has been designated as the primary institute for testing potential therapies against AIDS.

NIAID's program of drug trials for AIDS was established in June 1986, FIVE years after the epidemic started; enrollment of patients in clinical trials began 6 months later. The AIDS Treatment Program consists of the Treatment Branch (headed by Dr. Dan Hoth) and 5 other branches which function in the areas of research, drug and vaccine discovery, data analysis, epidemiology and prevention. The Treatment Branch is responsible for conducting AIDS clinical trials and has 3 components: 1) the AIDS Program Office at NIAID; 2) the AIDS Clinical Trials Group (ACTG, coordinated by Dr. Hoth), located at 35 hospitals around the country; and 3) the AIDS Clinical Trial Coordination Center (ACTCC), where all the data from clinical trials goes for analysis.

AIDS & THE FDA

There are basically three ways a person with HIV-infection could get access to a promising drug, and the FDA controls all of them:

1) By getting a doctor's prescription and buying an approved drug (such as AZT for AIDS or Bactrim for PCP),
2) By enrolling in a clinical trial of an experimental drug (such as Foscarnet for CMV), and
3) By obtaining the drug in the "underground" market or abroad (such as getting AL-721 in a health food store or Ribavirin in Mexico).

By law, the FDA must approve all drugs sold on the open market as safe and effective. It must also approve all experimental drug trials as reasonably safe, in relation to the possible benefits of research and risks of the trial, to subjects participating in them. And the FDA can raid a health food store or buyers' club for making unsubstantiated medical claims for food substances, and can block imports of foreign drugs, or interstate transportation of unapproved substances.

The FDA regulates the entire process of testing experimental drugs in humans, following the drug through the various phases of testing and examining the data submitted by the trial sponsor after the completion of trials to determine if the drug meets the standards legislated by Congress in the FDA's charter, originating in 1906 and significantly strengthened in 1938 and 1962.

The FDA lies at the crux of virtually every issue concerning treatments for AIDS. Its tasks are clearly defined, and it has the power under present legislation to meet the needs of ADS communities. Yet it prevents people with HIV from gaining access to test drugs as zealously as if there were already many marketed treatments for the disease.

In the case of AIDS, no drug could have a graver endpoint than the untreated disease itself. Moreover the one approved treatment, AZT, is far from a cure. The FDA must become pro-active and not reactive in the fight against AIDS. The intention of this handbook is to make as clear as possible the myriad ways the lives of persons affected by AIDS depend on the FDA. (SS/MH)

FDA: WHO DOES WHAT

Dr. Frank Young, who was previously Dean and Vice President at the University of Rochester, is the Commissioner of Food & Drugs. The FDA is currently structured into Centers for Drugs and Biologics, for Food Safety and Applied Nutrition, for Veterinary Medicine, and for Devices and Radiological Health. The last center on the list, because it regulates testing, approval and marketing of such devices as surgical gloves and condoms, is of some interest to people involved with AIDS. But it is the Center for Drugs and Biologics, headed by Dr. Robert Temple that, because it regulates drugs, vaccines and diagnostic tests throughout the testing, approval and marketing process, is of primary concern to AIDS activists.

In October 1987, under the impact of the AIDS crisis, the Center for Drugs and Biologics was divided in two. The Center for Biologics Evaluation and Research (CBER) is responsible for the safety of the blood supply and reviews experimental vaccines, blood products, diagnostic kits and the new biological drugs (derived from blood, from recombinant DNA technology or monoclonal antibodies). 75% of the activities of CBER, which employs 340 people, relate to AIDS. The new Division of Cytokine Biology plans to study cell biology and immunology in depth. Dr. Paul Parkman, a specialist in viral diseases, is CBER Director and coordinates the FDA's AIDS activities across all its divisions.

Carl Peck joined FDA in October 1987 to direct its new center for Drug Evaluation and Research. CDER reviews most new AIDS drugs. James Bilstad heads its Office of Anti-Virals. The Office's new Division of Anti-Viral Drugs reviews potential antiviral, antimicrobial and metabolic agents. Its Acting Director, Dr. Ellen Cooper, given primary credit for the speed with which FDA approved AZT, exerts more power over AIDS drugs than most of her superiors. In addition to her duties at FDA, she sits on the AIDS Clinical Drug Development Committee of the AIDS Clinical Trials Group (ACTG) of the NIH. This Committee is the group that is most responsible for deciding which potential AIDS therapies the government will or will not test. (JE)

 

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