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TESTIMONY OF HON. ELLIOT L. RICHARDSON, SECRETARY OF HEALTH, EDUCATION, AND WELFARE; ACCOMPANIED BY STEPHEN KURZMAN, ASSISTANT SECRETARY FOR LEGISLATION; RODNEY H. BRADY, ASSISTANT SECRETARY FOR ADMINISTRA. TION AND MANAGEMENT; MERLIN K. DUVAL, M.D., ASSISTANT SECRETARY FOR HEALTH AND SCIENTIFIC AFFAIRS; CHARLES C. EDWARDS, M.D., COMMISSIONER OF FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION; ROBERT W. BERLINER, M.D., DEPUTY DIRECTOR FOR SCIENCE, OFFICE OF THE DIRECTOR, NATIONAL INSTITUTES OF HEALTH; AND PETER B. HUTT, ASSISTANT GENERAL COUNSEL FOR FOOD, DRUGS, AND PRODUCT SAFETY FOR OFFICE OF THE GENERAL COUNSEL

Secretary RICHARDSON. Thank you, Mr. Chairman and members of the subcommittee.

May I begin by identifying, for the record-I need not introduce them since I know you are acquainted with them already—the colleagues who accompany me here today.

On my immediate right is the Assistant Secretary for Health and Scientific Affairs, Dr. Merlin K. DuVal; on my left are the Assistant Secretary for Legislation, Stephen Kurzman; the Commissioner of Food and Drugs, Dr. Charles C. Edwards; and the Department's Assistant General Counsel for the Food, Drugs, and Product Safety, Peter B. Hutt. On my right are the Assistant Secretary for Administration and Management, Rodney H. Brady; and the Deputy Director for Science, Office of the Director of the National Institutes of Health, Dr. Robert W. Berliner.

I appreciate, Mr. Chairman and members of the subcommittee, the opportunity to appear before you today to present the administration's views on titles I and II, the executive reorganization provisions of S. 3419, the Consumer Safety Act of 1972.

With respect to your determination, Mr. Chairman, and that of Senator Percy, to assure that strong and definitive actions be taken to assure the protection of the consumer, it should, I think, be noted and underscored that the most significant provisions of the legislation before you that would accomplish this are those of title Ill. It should be, I think, emphasized, that there is no significant difference between the views of the administration and the provisions of title 111 in S. 3419.

These are the truly significant operative provisions insofar as the increase in the effectiveness of consumer protection is concerned, irrespective of the organizational issues that have to do with the question of where these powers should lie.

Indeed, I think one might well say that all of the other issues are essentially those of reshuffling boxes on the organizational chart.

The question, really, of how effectively the consumer is protected is a question of what powers are vested in some agency, in some officials, and the degree to which these regulatory provisions are adequately comprehensive to do the job. And it is, as I say, significant in my view that as to those issues there is no disagreement among the proponents of legislation on this subject.

So we turn to what are essentially organizational issues and where the boxes belong within the executive branch.

S. 3419 would wrench FDA out of HEW, and so, therefore, before turning to the implications of this step, I believe it would be helpful to review briefly some of the actions which we have taken within HEW to improve FDA's performance and role in protecting the public health, a record which is the most dramatic in FDA's 66-year history.

STRENGTHENING OF CONSUMER PROTECTION SINCE 1969

The Food and Drug Administration has since its establishment in 1906 been the principal Federal agency charged with the protection of consumer health and safety. However, in 1969, when this administration took office, FDA was essentially a subagency within what was then known as the Consumer Protection and Environmental Health Service of HEW.

High priority was assigned to reexamining FDA's mission and organization and, as a result of that review, major changes were made during the first 2 years of the administration to upgrade FDA. First, FDA was elevated to full agency status within HEW, along with the National Institutes of Health and the Health Services and Mental Health Administration. Second, within FDA the product safety function was elevated to bureau status, placing it for the first time on a par with foods and drugs. And, third, related enforcement activities of the Bureau of Radiological Health, as well as a number of other departmental product safety functions formerly located elsewhere in the Consumer Protection and Environmental Health Service, were transferred to FDA.

BUDGET EXPANSION

In addition to reorganizing FDA, we have vastly increased its budget. In fiscal year 1970, the budget for FDA was $76.3 million. For fiscal year 1973, the Administration has requested $187.8 million, assuming enactment of the pending expansions of product safety and other authorities, which represents an increase of 148 percent over the past 4 fiscal years. The increase requested by the President between fiscal vears 1972 and 1973 is 70 percent, the largest in FDA's history.

With its improved organization and enhanced resources, FDA is now making the progress toward effective health and safety protection that the American consumer demands and deserves. As evidence of its greatly accelerated activity, Mr. Chairman, I would like to insert in the record at this point an enumeration of the consumer protection actions which FDA has taken in the first 4 months of this year.

Senator RIBICOFF. Without objection, so ord d.

Secretary RICHARDSON. Thank you, Mr. Chairman. It is, I believe, an impressive list.

(The list follows:) January 4.- Announced a massive, unprecedented program to review the efficacy of more than 100,000 over-the-counter drugs. Jun'iary 6.- Proposed a four-point program to ensure consumer safety in the

rs and cosmetics containing antibacterial chemicals.

January 31.-In a move to preserve the benefits of antibiotics for man, took new action to restrict their use for food animals.

February 15, March 9, and March 20.-Ordered child-resistant safety closures for use on aspirin products, certain furniture polishes containing petroleum distillates, lye products, and oven and drain cleaners.

March 10.--Ordered a phasing-out of lead from household paints.

March 10.- Acted to eliminate cross-contamination of animal feeds containing DES (diethylstilbestrol), the growth-promoting chemical.

March 17.- Proposed regulations to limit human exposure to PCB, a toxic commercial chemical, through our food supply.

March 24.--Published a proposal to ensure separation in function between the attorneys representing the Government at public hearings and the officials charged with decision-making authority, and to require that communications between these officials and affected parties in the private sector be made matters of public record.

March 30.—Proposed criteria for labeling packaged food with information from which consumers can determine nutritional values.

April 5.-Acted to close a loophole which has permitted diversion of illegal fireworks to consumer channels.

April 6.--Established a unique form of licensing for methadone to prevent misuse of this anti-heroin addiction drug.

April 7.—Announced a recommendation to make bicycles safer and called in manufacturers to seek corrections.

April 10.-Announced regulations for the voluntary registration of cosmetic manufacturers and the filing of product formulations.

April 13.-Proposed child safety packaging standards for charcoal starter and cigarette lighter fluids.

Secretary RICHARDSON. In addition to these actions, during the same brief period FDA issued 83 Federal Register notices implementing the continuing prescription drug efficacy study, 79 food additive notices, 62 new animal drug notices, and 83 other notices related to aspects of consumer safety.

Finally, the administration has also proposed substantial new consumer safety legislation to expand and improve FDA's regulatory authority still further, including S. 1797, the product safety bill which was the basis for title III of the bill now before this subcommittee, and bills expanding regulatory authority in the areas of medical devices (S. 3028), fish inspection (S. 700), drug listing (H.R. 9936), and food ingredient labeling (H.R. 14641).

PROGRESS IN FDA's 66-YEAR HISTORY

In sum, Mr. Chairman, the regulatory actions taken by FDA touch the lives of virtually every citizen and wide segments of industry, and each of the actions is subject to public controversy between those who argue the FDA has acted prematurely or too aggressively and those who argue that it has not gone far enough or fast enough. Within this difficult frame of reference, FDA has compiled a record in the past 30 months that can be favorably compared with any other regulatory agency in the Federal Government. It is no exaggeration to say, as I have, that this has been the most dramatic period of progress in FDA's 66-year history.

NEED FOR IMPROVED LEGISLATIVE AUTHORITY

But we cannot-and do not intend to-rest on the progress FDA has already made, substantial as it has been. We are proposing still further steps to insure the future safety and health of the Nation's

consumers. As I have stated, we have proposed S. 1797, the Consumer Product Safety Act of 1971, which would replace with a single, comprehensive regulatory system the patchwork of existing laws covering many, but not all, the potentially danerous products used in and around the home.

The need for such gap-filling and unifying legislation was very effectively demonstrated by the National Commission on Product Safety, an independent Commission established by the Congress. An interim report of the Commission, developed in cooperation with FDA, led to the enactment of the Child Protection and Toy Safety Act of 1969. The Commission's final report, issued in July 1970, noted that the law continued to leave unregulated, in regard to their mechanical, electrical, and thermal hazards, consumer products used by adults. Its report cited departmental statistics indicating that up to 20 million injuries a year may be traceable in whole or in part to such product hazards as untempered glass doors, unshielded rotary mowers, and defective power tools and small appliances. Accordingly, the Commission recommended comprehensive Federal legislation authorizing the setting of safety standards for all household products and the banning of unsafe products from the marketplace, and establishing a permanent independent commission to enforce these product-regulation authorities.

After studying its final report, the administration agreed with the Product Safety Commission that additional household product regulatory authority is very much needed. But we also concluded that this authority should be vested, not in a newly created independent commission regulating only household products, but in the Department of Health, Education, and Welfare, which has the primary responsibility in the executive branch for protecting the public health, and therefore, through FDA, is already administering those consumer health and safety protection laws having the greatest breadth. These include, as you know, the Federal Food, Drug, and Cosmetic Act, the radiation control for health and safety program, and the Federal Hazardous Substances Act. Enactment of the President's reorganization proposals, by transferring these as well as other product safety programs to a new Department of Human Resources, would further consolidate consumer protection responsibility in a single Federal entity. Centralizing these responsibilities in this way would, we concluded, give Federal consumer protection efforts a single direction, a more rational ordering of regulatory priorities than is now possible, as well as coordinated, and therefore enhanced, enforcement.

NEW RESPONSIBILITIES FOR FDA

Along with our product safety bill, S. 1797, the administration also committed itself to strengthening the organizational structure for product safety within our Department so that it could exercise more effectively the new responsibilities that our product safety proposal would give to us. When I testified in favor of S. 1797 before the Senate Commerce Committee, I transmitted a letter to the chairman from President Nixon announcing the intention to improve our consumer protection activities further, once the bill was enacted, by establishing within HEW a Consumer Safety Adminstration with a reorganized

FDA at its core. The new agency would be composed of three major offices: the Office of Product Safety Regulation, the Office of Drug Regulation, and the Office of Food Regulation. These offices would be supported by information collecting, field surveillance, and research capabilities, foundations for which already exist within the Department. A National Center for Consumer Safety Statistics would be established to collect, analyze, and disseminate information on injuries and their causes, as they are associated with food, drugs, and consumer products. In his letter to the Commerce Committee the President concluded by stating:

The Consumer Safety Administration will continue the work of the Food and Drug Administration. At the same time, the new unit will be structured so that the regulation of hazardous consumer products authorized in S. 1797 will have prominence that will ensure an effective, efficient and responsive product safety program. Finally, where possible, common facilities such as laboratories and field offices will be utilized to gain the maximum possible cost effectiveness.

S. 1797 is a strong bill which will fully satisfy the public need for adequate protection against hazardous consumer products, and Secretary Richardson has acted to ensure that his Department is fully capable of implementing this needed authority. I urge your Committee to report s. 1797 favorably to the Senate.

TITLES I AND II OF S. 3419, REORGANIZATION FOR ITS OWN SAKE

Regrettably, the Senate Commerce Committee instead chose a very different course. It reported a new bill, S. 3419, containing in title III an expansion of Federal product safety regulatory authority similar to that proposed in the administration bill. But it chose to add to the bill, in titles I and II, a sweeping reorganization going far beyond the reorganization proposed by the administration and even beyond the reorganization proposed by the National Product Safety Commission. Apparently, our testimony had some effect in persuading the committee that the Commission's reorganization proposal was not desirable because product safety regulation had important interrelationships with safety regulation of food, drugs, and cosmetics. Ironically, however, the Commerce Committee did not stop with that sound conclusion and instead went on in titles I and II to wrench the entire FDA out of HEW, creating still another in the galaxy of independent regulatory agencies.

REPORT NO. 92–749

The Commerce Committee report on S. 3419 (Rept. No. 92-749, p. 8) states: "There is an urgent need to make the Federal Government responsive to its mission to protect consumers against unsafe products.” We fully agree and this is why we have so urgently pressed for the greatly increased regulatory activity and effectiveness on the part of FDA which I described in the opening pages of my testimony today. But the committee report goes on to argue that independence from an established executive department is somehow crucial to fulfilling the need for responsiveness, to resisting the pressures of politics and competing public and private interests, to the visibility and accountability of decisionmaking, and, impliedly at least, to the ability to utilize increased resources effectively.

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