MAJOR PROGRAMS

Medical and Scientific Review and Evaluation

Provides for the review of drug safety and efficacy, including adverse reaction reporting and the review of chemicals and other substances in foods and cosmetics.

Research and Methodology

Involves fundamental research on products FDA regulates, as well as scientific experimentation on methodology.

Interagency Coordination

Promotes integration of the work of FDA and other governmental agencies. Consumer and Industry Relations

Promotes voluntary cooperation between the public, the regulated industries, and the FDA through education and information means.

Enforcement

Provides for the basic regulatory programs including field inspectional and analytical activities, and enforcement actions.

Regulations

Provides interpretations of laws and establishes guidelines and rules to be observed by the affected industries.

General Support and Executive Direction

Provides the Agency's operational elements with executive direction, and staff support.

FEDERAL REGULATION OF INTERSTATE COMMERCE OF FOODS AND DRUGS GOES BACK 60 YEARS

Significant dates in the evolution and organization of the Federal program

are:

1906-Enactment of the Food and Drug Act.

1927-Establishment of a separate law enforcement agency (in U.S. Department of Agriculture) called the Food, Drugs, and Insecticide Administration.

1931-Change of name to Food and Drug Administration.

1938-Enactment of the Federal Food, Drug, and Cosmetic Act repealing 1906 Act.

1940 Transfer of FDA from U.S. Department of Agriculture to the Federal Security Agency.

1953-Federal Security Agency became the U.S. Department of Health, Education, and Welfare.

1951 to 1965-Fundamental improvements made in the Food, Drug and Cosmetic Act by several amendments: Durham-Humphrey, Food Additives, Color Additives, Pesticide Chemicals, Factory Inspection, Kefauver-Harris, Drug Abuse Control.

1960-Federal Hazardous Substances Labeling Act.

1966-Child Protection Act.

1966-Fair Packaging and Labeling Act.

FISCAL YEAR 1966 ACHIEVEMENTS

In Fiscal Year 1966 the Federal Drug Administration

-made 46,000 establishment inspections.

-collected over 100,000 samples.

-made 98,000 laboratory analyses.

-had over 1,300 court actions.

-reviewed about 400 applications for new drugs and maintained surveillance over clinical studies of about 2,000 experimental drugs.

-reviewed over 13,000 adverse drug reaction reports involving more than 500 drugs.

-expanded research on natural food contaminants, aflatoxin, and chroma, tographic methods.

-issued 305 orders under pesticide and food additive authority.
-certified about 27,000 batches of antibiotics, insulin and colors.

FDA'S MISSION

FDA's mission is to insure that

-foods are safe, pure, wholesome.
-drugs are safe and effective.

-cosmetics are harmless.

-therapeutic devices are safe and effective.

-all of the above are honestly and informatively labeled and packaged. -dangerous household products carry adequate warning or are banned. -psychotixic drugs are better controlled and counterfeiting is stopped. (FDA does not have jurisdiction over the pricing of these products.) Technically this is done through enforcement of the Food, Drug, and Cosmetic Act of 1938, as amended, and six related laws:

Federal Caustic Poisons Act.

Filled Milk Act.

Import Milk Act.

Tea Importation Act.

Federal Hazardous Substances Act.

Fair Packaging & Labeling Act (Effective July 1, 1967).

Each of these Acts vests enforcement authority with the Secretary. This authority is delegated to the Commissioner of Food and Drugs. To accomplish this mission FDA

-inspects factories, warehouses, and distributors.

-samples and examines interstate and imported shipments.

-clears new drugs for safety and effectiveness before they are marketed. -checks prescription drugs to assure they are sold only upon prescription. -tests every batch of insulin, colors, and antibiotics for humans before they are sold.

-establishes safety tolerances for food additives, pesticide residuals, and

colors.

-evaluates hazardous household and children's products for warnings or to ban them.

-works with the Department of Justice to bring court actions where necessary.

-checks claims for devices, vitamins, "miracle cures"-takes action against false claims and bogus devices.

-audits handlers of depressant and stimulant drugs.

And also

-conducts research.

-assists in the interchange of scientific information.

-works with industry to promote voluntary compliance.

-conducts a program of consumer information and education.

-works with State and local agencies on food and drug matters.

STATISTICS INVOLVED IN FDA WORKLOAD

About 114.5 billion dollars worth of foods, drugs, cosmetics, and hazardous household chemical aids marketed each year:

There are 2.5 million annual interstate shipments of fruits and vegetables.
There are 2,400 chemical additives used in or on foods.

About 1,000 new drugs are clinically tested by industry each year.

FDA workload covers these establishments:

77,075 dealing in foods.

23,000 handling drugs.

2,100 dealing in cosmetics.

4,900 handling hazardous substances.

503,000 commercial import shipments of foods, drugs, and cosmetics (calendar year 1965).

And:

Attempts to control multi-million dollar quackery racket.

Mr. JARMAN (presiding). Thank you, Dr. Goddard, for being with us for your briefing this morning to the committee.

I would like to take this opportunity to commend you and your Department for the expeditious way in which you set up a meeting with private industry on the problem of the number of children's aspirin in a bottle.

The results that were achieved in a voluntary way is something that certainly we on this committee hoped for and we appreciate very much the speed with which you handled it.

Dr. GODDARD. Thank you. The policy statement pursuant to the voluntary conference is ready for the Federal Register now. Mr. JARMAN. Mr. Rogers.

Mr. ROGERS. Thank you, Mr. Chairman.

I, too, join in those remarks. It is good to see you here today. I think this approach to call an industry conference to try to get their views is always in the consideration that the public interest must be heeded. I think what can be done in this way is helpful.

Also, I was pleased with your handling of the consent provisions. I think the Department has done an excellent job there in trying to work out some of these problems.

What are the main loopholes that you see now in stopping this drug abuse after the passing of the law? Are there any major loopholes still existing?

Dr. GODDARD. If you are speaking about the law itself, I don't believe that we have

Mr. ROGERS. Or enforcement, or how they are doing.

Dr. GODDARD. The law itself still seems to be a very sound one, Mr. Rogers. We are working with the States, we have provided a model law for them to follow and some of them are adopting it.

We think in principle it is still sound that the Federal agency not concern itself with the individual abuser who may be in possession of some of the drugs under control and that we should concentrate on those who are the suppliers, the sellers of these drugs, the producers, if you will. We have made, we think, some progress.

One of the indications of progress is the price of the drug in the marketplace.