in experienced professional judgment. In our opinion, the greater safety factor can be gained by retention of drug regulation within this professional and health oriented environment. Drug evaluation and regulation must be conducted in a manner reflecting the urgent requirements for a full-range armamentarium to fill our therapeutic needs and the continuing right of the public to expect safe and efficacious products. The National Commission on Product Safety, which studied the problem of regulatory reorganization for four years, concluded that drugs were not "household products." Indeed, the Commission specifically excluded drugs from the scope of its proposed legislation. Drugs cannot and should not be analogized with ordinary consumer durables. Nor can evaluation of their safety and efficacy be dissociated from the mainstream of scientific and professional deliberations. There has been considerable criticism regarding the performance of the FDA in the regulation of pharmaceutical development. While some criticism is justified, an observation can be made that the Food and Drug Administration has encountered difficulty-as would any agency administering its function-in recruiting and retaining an adequate number of qualified personnel to carry out its duties. However, in fairness it should also be noted that the FDA's activities have been growing more rapidly than its resources. In our opinion, the soundest course of action would be to enhance and improve this existing and viable institution. This view is shared by many, and this attitude is reflected further in the Administration's budget request for an appropriation of $180 million for fiscal year 1973 for FDA-a $67 million increase over the previous year. This constitutes a meaningful step toward rectifying its shortcomings and increasing its effectiveness. The FDA affords the advantages of an existing system. It should be improved and revitalized. We believe such results could be accomplished without resort to a new agency entailing uncertainties adn complications in creation, organization and operation. This would also prevent any lapse in effectiveness of operation resulting from the transfer of functions. Moreover, the legislation in question runs counter to a growing consensus that government health related functions should be brought together within a cabinet level Department of Health. The American Medical Association has long advocated the creation of such a Department in order to provide coordination to the many widespread health activities of government. We are encouraged by the increasing support, in and out of Congress, which this proposal now enjoys. There is compelling logic to create such a Department and to include within its ambit of authority the Food and Drug Administration. Such action should provide the means for establishing priorities among all our health endeavors and to insure the level of compensation and performance desired. In this way we are more likely to insure the health dividend which we all seek. We recommend that the Food and Drug Administration should receive additional support in order to enable it to increase its effectiveness, and that it should be in the Department having principal responsibilities for health matters-presently the Department of Health, Education, and Welfare. Sincerely, ERNEST B. HOWARD, M.D. EXHIBIT 66 ABERMAN, GREENE & LOCKER, Hon. ABRAHAM RIBICOFF, Washington, D.C. DEAR SENATOR RIBICOFF: We represent the Toy Manufacturers of America, Inc. (TMA), a trade association of domestic toy producers, whose members account for approximately 85%, by dollar volume, of the toys sold in the United States today. Our client has requested that we write you on its behalf stating its views on pending legislation bearing the short title of "Consumer Product Safety Act of 1972." (S. 3419). TMA welcomed the opportunity to go on record in support of amendments to the Federal Hazardous Substances Act known as the Child Protection and Toy Safety Act of 1969 (15 USC 1261, et seq.) which increased protection to children against hazards to their safety and health. TMA is also in accord with another basic objective of industry in the United States, namely, that much should be done to further the objective of safety in products which are found in and around the household which may produce accidental injury, illness or death. We believe product safety is a vital concern not only to consumers but also to TMA and industry in general. Apart from the humanitarian reasons which promote such concern, we believe it is vital to business survival to retain consumer confidence through the manufacture and distribution of safe products. We also believe that it is impossible to achieve absolute freedom from risk of injury in the use of products produced by industry. Nevertheless, we do agree that it is essential that industry, government and consumers continuously strive to reduce the risk level of consumer products to as close to zero as is possible. Fundamental to our belief is the premise that maximum safety of any product is achieved initially in the conceptual and subsequently in the design, development and production stages of the product. This imposes the greatest of responsibilities on industry. It is for these reasons that we wish to go on record in support of S. 3419. The bill, in our opinion, would meet the maximum safety objectives of the American consumer by the development of a consumers' safety program which would include the promulgation and enforcement of consumer product safety standards to reduce the risk attendant in consumer use in and around the household. We believe it is vital that such consumer product safety standards precede the exercise of any authority on the part of any governmental agency to ban hazardous household products. Our industry has since 1969 been subject to the interim recommendations of the National Commission on Product Safety embodied in the Child Protection and Toy Safety Act of 1969. Such legislation enacted by Congress resulted in the banning of certain industry products on a “hindsight" basis by the F.D.A. Although we supported this legislation, we believe that effective legislation should require the development of product safety standards whenever it is ascertained that a safety standard is necessary to remove or reduce an identifiable product hazard. This is consistent with our belief that the application of safety standards to products should come before the failure, malfunction, misuse or injury occurs. The development of a safety standard would insure that industry would produce products which do not present hazards because industry has been presented with a standard to be followed before it commences production of its products. This is the surest and most effective way to insure that safe products are placed in the hands of the American consumer. TMA believes that any consumer safety product legislation (and this is consistent with the provisions of S. 3419) should permit the use of an existing product safety standard which has been published by any federal agency or other qualified agency, organization or institution. Alternatively, it should permit the acceptance of offers to develop proposed product safety standards by technically competent agencies or organizations. The role of the federal government in the development of such safety standards should be limited to those cases where existing standards are insufficient, or industry is unable or unwilling to specifically develop a proposed product safety standard which is necessary to remove or reduce unreasonable risks or product hazards. TMA also believes that the federal presence in the area of product safety, as contemplated by S. 3419, should in addition be concerned with (a) collection of information on consumer product risks; (b) the need for the development and promulgation of standards; (c) inspection and enforcement by banning action, where required, only after the product standard has been developed : (d) use of laboratory facilities of the federal government to assist industry in resolving technical problems of national magnitude; (e) consumer education. TMA believes that all household consumer products including, but not limited to, those products presently within the jurisdiction of the Federal Hazardous Substances Act, the Radiation Control for Health and Safety Act of 1968, the Flammable Fabrics Act, and the Poison Prevention Packaging Act of 1970 should be subject to the jurisdiction of the Consumer Safety Agency. It is essential that standards development and the means for enforcing such standards be placed within a single federal agency, in order to achieve uniformity in the development and application of safety standards for household products by industry. S. 3419 properly places jurisdiction in the Consumer Safety Agency. S. 3419 contains a strong federal preemption provision. Since industry will gear the design and manufacture of its products to the existence of the safety standards and granting the premise that the federal standards would provide a method to insure the manufacture, development and design of safe products, it is our conviction that no state or city or other political subdivision of a state should have any authority either to establish or to continue in effect any safety standard or regulation applicable to a consumer product to which a federal safety standard applies. On behalf of our client, we should like to thank you for the opportunity of submitting this statement for the American Toy Industry. Very truly yours, EXHIBIT 67 AARON LOCKER. Hon. ABRAHAM RIBICOFF, MERCK & Co., INC., Rahway, N.J., May 10, 1972. Chairman, Subcommittee on Executive Reorganization and Government Research, U.S. Senate, Washington, D.C. DEAR SENATOR RIBICOFF: Merck & Co., Inc., one of largest U.S.-based producers of prescription drugs and biologicals, strongly believes that the best interests of the public health are served when good medicine and good science govern the regulation of these products. We support regulation of health products where competence in health matters lies. This means retaining such regulatory responsibility within the Department of Health, Education and Welfare or whatever successor agency-a Department of Human Resources or a Department of Health Congress ultimately decides to establish. Accordingly, we urge deletion of titles I and II from S. 3419, the proposed Consumer Safety Act of 1972. Control of the development, testing, and use of drugs and biologicals is one of the most sensitive and difficult regulatory functions of government. Successful and efficient performance demands that the regulators have outstanding medical and scientific resources of their own, that they have access to and use professional and technical competence in other settings, and that they be governed in the final analysis by judgment that blends medical and scientific consensus with a highly developed sense of the public interest. The consequences of failures of commission or omission in the drug and biologicals regulatory process are enormous and can be catastrophic, as when unforeseen safety problems arise with a product that is in widespread use or when a drug or vaccine is unnecessarily withheld from general use because of timidity or bureaucratic entanglement. Both drugs and biologicals have been regulated under law for half a century. There have been regulatory failures, but a few may be inevitable. Since in the regulation of drugs and biologicals one is dealing with matters of judgment, not only matters of fact, the way to minimize and hopefully to prevent such failures is to increase the identification of the regulatory process with good science and good medicine, not to obscure such identification. Fundamental to the capacity of a health regulatory agency to function in the public interest is recognition of, and ability to make decisions in the presence of, risk. For every drug and every biological, new or old, there are risks that must be weighed against its benefits. It may permit control of hypertension but cause adverse reactions in some patients. It may permit control of polio but cause neurological disorders in one child in 10,000. For man cannot be summed up in the equations of the mathematical and physical sciences; man is a biological organism, and the essence of biology is variation and change. Thus what benefits the many may harm the few. The regulators in the health field have the unenviable task of deciding when the available evidence suggests that benefits outweigh risks, and that a given drug or vaccine should be approved even though a known risk is involved. This judgment, often referred to as the benefit-to-risk ratio, is the hardest thing for many people to understand at a time when, increasingly, the demand is for 100% benefit and zero risk. We believe that titles I and II of S. 3419 would have an impact on the decisionmaking processes in the regulation of drugs and biologicals that would harm the health and safety of the consuming public. A factor other than what is good medicine and good science, taking into account the public interest, would enter the arena. Those who, for 200,000,000 Americans, decide whether the nation will or will not take risk A in order to achieve benefit B would be influenced by new inputs asking why the people should be subjected to any risk, why they cannot get predictable and unvarying benefits. Perhaps it is different in the governmental processes by which a nation decides whether it will risk flammable fabrics as an exchange for the texture-soft nightgown, or hazards in exchange for the glitter on Christmas trees. But in the case of drugs and biologicals, the nation is dealing with people as a whole instead of with isolated incidents of product failure. For drugs and biologicals, it is the success ratio that matters. We have differed, often, with the Food and Drug Administration and the Division of Biologics Standards of the National Institutes of Health about what constitutes good medicine and good science. But in the final analysis, we believe the public interest is best served-and our own interests are best served-by regulations that make and have the capacity, increasingly, to reflect good medicine and good science in the decision-making processes. It is for this reason that we oppose titles I and II of S. 3419 that would have the effect of removing the decision-making with respect to drug and biological regulation away from contexts in which good medicine and good science predominate and into a context in which individuals who are uninformed and untrained in the benefit-to-risk ratio could dominate. In other words, Merck-as a senior member among the regulated-urges stronger regulation on the basis of true medical and scientific consensus rather than regulation that could be dominated by those whose professional inexperience would have a tendency to delay all advances in the treatment and prevention of disease. Sincerely, EXHIBIT 68 HENRY W. GADSDEN. Hon. JOHN L. MCCLELLAN, OFFICE OF THE SECRETARY OF TRANSPORTATION, Chairman, Senate Government Operations Committee, DEAR MR. CHAIRMAN: The purpose of this letter is to provide the Committee the views of the Department on S. 3419, the bill reported on March 24, 1972, by the Committee on Commerce: "To protect consumers against unreasonable risk of injury from hazardous products, and for other purposes.” S. 3419 creates a new Consumer Safety Agency whose function would be to promote the public health and safety by protecting consumers against injury resulting from the use of foods, drugs, or other consumer products. The bill would transfer to the new agency food, drug, and product safety activities of the Secretary of Health, Education and Welfare, the Secretary of Commerce, and the Federal Trade Commission, and authorize the agency to promulgate for consumer products new or amended standards designed to eliminate unreasonable risk of injury or death associated with the use of those products. S. 3419 raises a number of major organizational issues, most of which do not directly concern this Department. On those issues, we defer to the views of other agencies of the Executive branch directly concerned. The bill as interpreted by the Committee on Commerce also raises an important jurisdictional issue with respect to the safety functions of this Department. Section 101(1) of S. 3419 defines the term "consumer product" to exclude (1) products subject to regulation under the National Traffic and Motor Vehicle Safety Act of 1966; (2) aircraft or other aeronautical products subject to safety regulations by the Federal Aviation Administration; (3) products subject to safety regulation under the Gas Pipeline Safety Act; and (4) vessels, appurtenances, and equipment subject to title 52 of the Revised Statutes, the Federal Boat Safety Act of 1971, or other marine safety statutes administered by the Coast Guard. We would interpret the language of section 101 (1) to reserve to this Department the exclusive authority to regulate from the safety standpoint the products enumerated above, and in light of the highly technical nature of many of the regulations involved, the interdependence of these regulations and other regulatory functions of the Department, and the high level of expertise developed in this Department to administer these regulations, we believe that such a result would be most sound and desirable. We note from their Report, however, that the Commerce Committee interprets the section to allow the new agency to regulate a product capable of being regulated under one of the numerated acts, but which is not actually subject to such regulation. Under the interpretation of the Commerce Committee, the bill apparently could give rise to the regulation by two different Federal agencies of the same industry for the same purposes. Such dual jurisdiction, although limited in scope, would unnecessarily complicate the operations of the Department, confuse the regulated parties, and necessitate the establishment in the new agency of a group of experts duplicative of transportation experts in this Department. S. 1797 does not create such overlapping responsibilities and, accordingly, we recommend that Congress enact S. 1797 in lieu of S. 3419. The Office of Management and Budget advises that from the standpoint of the Administration's program, there is no objection to the submission of this Chairman, Subcommittee on Executive Reorganization and Government Research, Committee on Government Operations, U.S. Senate, Washington, D. C. DEAR SENATOR RIBICOFF: I am writing in support of legislation being considered by your Subcommittee that would reorganize certain food and nutrition services now carried out by federal agencies. I especially support legislation that would transfer the administration of the Federal Meat Inspection Act, the Poultry Products Inspection Act, and related activities now carried on by the Department of Agriculture to a new agency specifically authorized and required to protect consumers. Meat and poultry inspection was centered in the Department of Agriculture when it began many years ago, largely because the Department's research staff included persons capable of carrying it out. Since that time, other functions of the Department of Agriculture have expanded greatly, and political pressures arising out of federal expenditures for farm programs, federal controls over land use, and other programs have intensified. The Secretary of Agriculture is expected to represent farmers, ranchers, and poultry producers, and he does so. Such interests are often directly opposite to consumer and broad public interests. This is the case in regard to inspection of meat and poultry products. The Secretary of Agriculture ought not have to represent directly two often-opposed constituencies. With meat and poultry inspection in a separate agency, the Secretary of Agriculture will still have the opportunity to state the views of producers, or his own, on questions of food wholesomeness and labeling, but he would no longer have the obvious conflict of interest he has today. The General Accounting Office has recently reported critically on the way the Department of Agriculture has performed these functions. My own experience as Under Secretary of Agriculture in the 1960's convinced me that the Department was uncomfortable with food inspection responsibilities, and that they should be transferred. I note also that the present Administration has recommended such a transfer as part of a general reorganization of the Executive Branch. For these reasons, I support your efforts to transfer food inspection services out of the Department of Agriculture. Sincerely yours, JOHN A. SCHNITTKER. |