CHEMICAL & ENGINEERING
NEWS VOLUME
40, NUMBER 45
T h e Chemical W o r l d T h i s W e e k
FDA'S ILLS. Dr. George Harvey (center) tells reporters that FDA needs to be completely reorganized. A citizens advisory panel, headed by Dr. Harvey, says FDA's cooperation with
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1962
industry and other government agencies is poor. FDA puts too much emphasis on police power activities, not enough on educating producers and consumers, the group feels
Broad Reorganization of FDA Urged More stress on education and cooperation, less on prosecution, proposed by citizens panel A drastic overhaul of the Food and Drug Administration is proposed by a citizens advisory committee in a report to the Secretary of Health, Education, and Welfare. The 16-member citizens group, appointed by former H E W Secretary Abraham Ribicoff and drawn from the fields of medicine, education, public administration, and business and consumer interests, has been studying FDA's problems for more than a year. FDA's chief problem is that it is oriented primarily to investigation and prosecution activities, the citizens committee reports. This emphasis on
police power activities, plus an apparent lack of genuine desire to cooperate with industry, a general negative attitude toward cooperation with other government agencies, and little activity aimed at educating consumers and producers, is harmful to FDA's best interests, the group says. According to the committee, FDA could use its resources to better advantage, if, in addition to its enforcement program, it concentrated on educating the public in consumer protection, developing within industry an awareness of industry's responsibility to comply with reasonable standards,
and encouraging voluntary compliance with FDA requirements. Proposed Changes. To enable FDA to do a better job of protecting the consumer and to become a more effective regulatory agency, the citizens committee makes these major recommendations: • Reorient the philosophy and leadership of FDA. • Reorganize the administration of FDA to keep pace with the responsibilities imposed on the agency. • Upgrade FDA's scientific programs. NOV.
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PROPOSED FDA REORGANIZATION PUTS NEW EMPHASIS ON EDUCATION AND PLANNING Secretary of Health, Education, and Welfare
National Food and Drug Advisory Council
Assistant Secretary
Commissioner of Food and Drug Administration
Deputy Commissioner for Operations
Deputy Commissioner for Planning
Food and Drug Institute
Bureau of Enforcement and Inspection
Bureau of Education and Information
Bureau of Administration
Field Offices
• Appoint a National Food and Drug Advisory Council to report annually to the Secretary of H E W on FDA activities. • Improve FDA-industry relationships. • Develop sound educational programs for consumers, industry, and state agencies. • Improve federal-state regulatory programs. Science Leadership. As FDA's task becomes more complex each year, the committee believes that broad training and experience in science are essential for successful performance in top policy-making jobs. It recommends that in the future scientists with broad administrative experience should be appointed to the high-level posts in FDA, including that of Commissioner. "It is questionable whether the experience acquired as an inspector usually provides the necessary quality and knowledge to meet present conditions of administration a* the policy level," the committee says. This could be interpreted as a sharp criticism of FDA Commissioner George P. Larrick and his deputy John L. Harvey. Neither man is a scientist and both joined FDA as inspectors and came up through the ranks. But, at a press conference, committee chairman Dr. George Y. Harvey of Missouri University's political science department 22
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made it clear that the committee has no criticism of Commissioner Larrick. "This report is directed at the future, not the past. Mr. Larrick can do the job if he takes the committee report to heart and surrounds himself with the right people," Dr. Harvey says. Revamped FDA. To carry out its recommendations the committee proposes a complete reorganization of FDA's administration. Purpose of the reorganization is to upgrade FDA's scientific work, provide more effective long-range planning, provide clear lines of authority and responsibility, and transfer much of the decision making to field offices under policy direction from headquarters. Under the new plan, the Commissioner would devote most of his time to such things as providing leadership in the philosophy and role of FDA, developing major programs for industry and consumer relations and education, and developing objectives and policies for FDA. Operating functions now a part of the Commissioner's office would be reassigned to the proper line operating office. To upgrade FDA's scientific activities the committee proposes a Food and Drug Institute. The institute would be the focal point for all FDA scientific activities. In the committee's opinion the scientist selected to head the new institute should be of such caliber that he could quickly bring the
institute to a position of leadership in research on consumer protection. The staff of the institute would be permitted to hold joint appointments with universities and other scientific centers and the institute would be able to make research contracts and issue grants for special research projects under the committee plan. The institute would also have advisory councils with members recruited from such organizations as professional societies, universities, and the National Research Council to give advice on policy and other problems. The proposed FDA reorganization also provides for a National Food and Drug Advisory Council. This g r o u p composed of 15 to 20 persons prominent in science, industry, Government, and representatives of the p u b l i c would be appointed by the Secretary of H E W but would be advisory to FDA. Purpose of the council, the committee says, is to appraise the work of FDA, advise it on policies and programs, and serve as a sounding board for proposed developments of major concern to the effective administration of the Federal Food, Drug, and Cosmetic Act. The council would meet at least four times a year and furnish an annual written report on FDA activities to the Secretary of HEW. Industry Relations. The committee is especially disturbed about present industry-FDA relationships. These
are not based on common understanding, trust, and respect, the committee says, but are founded on fear, questioning of basic motives, and lack of opportunity for discussion before drastic action is taken on violations. To improve these relations, the committee recommends that a medium be created through which Government, industry, and the public can meet regularly on an equal footing to discuss common problems and plan cooperative programs. In addition, ideas could be freely exchanged on the interests of each and the ultimate objectives of obtaining the best consumer protection. In the committee's opinion, the proposed National Food and Drug Advisory Council would be an ideal forum for these exchanges. FDA should encourage industry to assume its share in the regulatory process, the committee says, because the Government could never employ enough people to provide adequate supervision at all time in all places. FDA should make the utmost effort to create a sincere desire on the part of industry to help in developing standards and to comply voluntarily with standards established for the consumer's health and welfare, the committee says. As the committee sees it, this course of action will free more government inspectors to supervise those problem areas where they are most needed. It will also create a feeling of cooperation and respect among ethical producers who honestly desire to put out the best possible product and to serve the public interest, the committee says. An important aid in improving industry relations is the industrial relations division to be set up in the proposed Bureau of Education. This division would function as liaison between industry and FDA. It would serve as an important channel for bringing industry opinion to FDA and it would help FDA to develop programs for self-policing by industry. In addition, the committee believes that the new unit could act as a resource unit within FDA, obtaining from industry and other bureaus of FDA information to be used in preparing manuals, bulletins, and other publications for dissemination to industry and to consumers. Secretary of Health, Education, and Welfare Anthony J. Celebrezze says the department will carefully analyze the committee report and promptly review its recommendations.
New Drug Joins Malaria Battle Clinical trials show that a single dose of new antimalarial is effective for about a year Scientists have taken a big step toward a new approach to the eradication of malaria—an ancient, yet persistent, disease which still afflicts millions annually. That step is the discovery of a long-acting antimalarial drug. The new drug, which hurdles the problem of frequent dosing, could provide better control of malaria or even its eradication. Developed by scientists at ParkeDavis, the drug is the pamoic acid salt of a dihydrotriazine. Still in the experimental stage, it is designated as CI-501. Unlike most antimalarials, C1-501 is injectable. Key property of the drug is its prolonged action. After injection, CI-501 is absorbed slowly into the blood stream. The amount of drug released is sufficient to maintain a high level of immunity to malaria for more than six months, Dr. Paul E. Thompson, lab director in parasitology at Parke-Davis, told the American Society of Tropical Medicine and Hygiene, meeting in Atlanta, Ga., last week. Tests have been encouraging. Early studies at Parke-Davis showed that CI-501 protects monkeys infected by transfusions of malaria-infected blood for up to 50 weeks. And subsequent investigations at Christ Hospital Institute of Medical Research in Cincinnati indicate that it is just as effective in monkeys infected with malaria parasites from mosquitoes. Moreover, a
Parke-Davis Makes Salt of Triazine Derivative
with
single injection of CI-501 in volunteers nearly a year ago is continuing to protect them from malaria induced by heavily infected mosquitoes, according to the National Institutes of Health. Malaria still disables more people than any other single disease. Today, about a th.rd of the world's 3 billion people live in malarial or previously malarial areas. Of these, roughly 200 million are infected by malaria parasites and the disease claims an estimated 2 million lives every year. Cost of complete eradication with currently available approaches is between $1.5 and $2 billion, according to the World Health Organization. But many authorities believe complete eradication, with present methods, would be difficult or impractical. The most widely used control methods are built around insecticides and drugs, with more recent emphasis on the latter. The insecticide approach looked very promising as a route to eradication—until the mid-1950's, when insect resistance became a major factor. Now health officials are leaning more toward chemotherapy. Currently available drugs pose one big problem, though: The body doesn't use them efficiently. Therefore they must be taken continuously at about two-week intervals for maximum protection. The trouble with this is that it just isn't economically feasible or practical to dose everybody
.Pamoic Acid to Get Long-Lasting Antimalarial Drug
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