MEDICAL AND NURSING BOOKS, SOLE OR SENIOR AUTHOR, continued Member, Ad Hoc Committee of Association of American STATEMENT OF ANDREW J. BIEMILLER, DIRECTOR, DEPARTMENT OF LEGISLATION, AMENDING THE FEDERAL FOOD, DRUG AND COSMETIC ACT, BEFORE THE SUBCOMMITTEE ON HEALTH, OF THE SENATE COMMITTEE ON LABOR AND PUBLIC WELFARE. May 1, 1970 Mr. Chairman, the AFL-CIO appreciates this opportuntiy to express our views with respect to S. 3096, S. 3297, S. 3651 and S. 3652 which would amend the Federal Food, Drug and Cosmetic Act in the following ways: 1. Require prescription drugs and/or their containers to have a code which would represent the identity of the manufacturer of the drug, the identity of the final packager of the drug, the dosage form and strength of the drug and the number of units in the container. Both S. 3096 and S. 3297 would provide for ready identification of prescription drugs to facilitate drug recalls. The coding requirements of these bills would also reduce errors in prescribing and dispensing drugs. 2. Require inspection every six months of factories and establishments in which food, drugs, devices and cosmetics are manufactured, processed, packed or stored. 3. Require that labels of drug containers bear the established name of drugs. Mr. Chairman, the AFL-CIO's interest in these bills stems from concerns of union members and their families as consumers of prescription drugs. The AFL-CIO has advocated the following general objectives with regard to prescription drugs: 1. All drugs sold for human use must be safe, effective and meet standards of purity and potency. 2. The cost of prescription drugs must be reasonable. 3. Patients should have reasonable assurance that the drugs their doctors prescribe are indeed necessary or desirable for treating their illness and that the most effective drug is used where more than one drug is effective. The accomplishment of these objectives will by no means be a simple task. Experience has demonstrated that. The hearings on Competitive Problems in the Drug Industry before the Subcommittee on Monopoly of the Select Committee on Small Business have pinpointed many obstacles to attaining these goals. Among the problems are: 1. An outpouring of "new" products which are basically not new at all. Most are simply duplicates of drugs already on the market put out under different trade names, new dosage forms of existing drugs or combinations of known drugs. Over the 10-year period from 1958 to 1967, only 311 of the 2,787 "new" drug products contained new single chemical agents not previously known. Of the 311 new chemical products, only about 30 actually represent any technological progress in chemical therapy. The accumulation of different trade names of the same drug, various dosage forms of the same drug and combinations of drugs promoted by a single trade name all add up to about 20,000 "products" on the market in the United States. Pharmacologists, physicians who spend all of their time in the study of drugs and chemo-therapy, admit that they cannot keep up with the proliferation of products. Dr. John Adriani, Chairman of the Council on Drugs of the American Medical Association and a member of the Revision Committee of the U. S. Pharmacopeia, testified before the Subcommittee on Monopoly as follows: "The problems of drug utilization and prescription methods are complex and are increasing in complexity as the number of drugs introduced into therapeutics increases. The situation can now be described as nearly chaotic. No semblance of order can be made of the existing chaos until all drugs and combinations thereof are designated by given, common or generic names and not by proprietary or brand names." 2. The promotion of the sale of drugs by trade name rather than by generic name inflates drug prices. 3. Physicians receive most of their information about drugs from the manufacturers through advertising or salesmen so-called drug detail men. There - is a deplorable lack of objective information regarding the effectiveness or relative effectiveness of different drugs. To deal with these problems, the Task Force on Prescription Drugs of the Department of Health, Education and Welfare has made a number of recommendations among which were: 1. The Congress should enact legislation requiring that the containers of all dispensed prescription drugs be labeled with the identity, strength and quantity of the product, except where this is waived upon specific orders of the prescriber. 2. Adequate financial support should be provided to the Food and Drug Administration for necessary educational and inspection operations so that acceptable quality control methods can be instituted and properly maintained in all drug manufacturing and packaging establishments. S. 3096 and S. 3297 would implement the first recommendation above and indeed improve upon it by providing ready identification of drugs to facilitate recalls. It is our understanding that different preparations of the same drug manufactured by the same company may vary in potency and purity. We therefore support particularly Sec. 504(d) of S. 3096 giving the Secretary the authority to require the code to also identify the lot or batch from which the drug was manufactured. S. 3297 omits this important provision. S. 3651 implements the second recommendation listed above, and S. 3652 would be a step toward the goal of promoting generic prescribing. Mr. Chairman, taken together the bills now before this Subcommittee represent important proposals toward achieving general objectives the AFL-CIO has advocated with respect to prescription drugs. With your permission, Mr. Chairman, I would like to include in the record at the end of this statement, the policy resolution on the high cost of drugs which was adopted by the last Constitutional Convention of the AFL-CIO in October 1969. Even if the bills before this Subcommittee were to become law, however, much more would be needed to provide the prescription drug consumer the type of protection he needs and deserves. We are pleased to endorse the objectives of the pending legislation and to urge that this Subcommittee move even further in the directions we have suggested in our resolution. Mr. Chairman, on behalf of the AFL-CIO, I wish to thank you for the opportunity to share with this Subcommittee our views on the pending legislation. We will appreciate your consideration of our statement. AMERICAN FEDERATION OF LABOR AND Policy Resolution on THE HIGH COST OF DRUGS Adopted October 1969 The hearings on drugs before the Senate Subcommittee on Monopoly, conducted by Senator Gaylord Nelson (D.-Wis.), have revealed the extraordinary extent to which the major pharmaceutical manufacturing companies are exploiting the American public. The major drug manufacturers profit from the fact that, while our medical schools offer theoretical courses in pharmacology to medical students in their second year, no course in the clinical application of pharmacology is given in the great majority of our medical schools. The result is that drug "detail men" or salesmen and promotional literature of the drug manufacturers have usurped the function of physician education. Physicians have virtually no objective and unbiased source of information about drugs and therefore rely heavily on what the drug manufacturers tell them. Nor is there objective research with regard to the effectiveness of new drugs which apply for licensure and introduction to the market place. The Food and Drug Administration does not, itself, evaluate the effectiveness of new drugs. Rather, the FDA largely reviews the work of the research conducted or sponsored and paid for by the company making the new drug application. Dr. James Goddard, former Commissioner of the FDA, has testified that most of the so-called research activities which support new drug applications amount to little more than testimonials. The regard with which the drug manufacturers, themselves, view the work of many of their physician researchers can be judged from the fact that the manufacturers refer to them as "proof mills" according to Dr. A. Dale Console, former Medical Director for E. R. Squibb and Co. Overzealous sales promotion has resulted in drugs being prescribed for diseases and conditions for which the prescribed drug is not even effective, for diseases and conditions for which the drug has greater potential for harm than good, and for diseases and conditions for which another drug would be more effective. Several prominent physicians have testified before the Nelson Subcommittee that twice as many drugs are prescribed as is necessary. Nobody really knows how many people die annually from overprescribing and misprescribing, but a study conducted by Johns Hopkins Hospital showed that 4 percent of all patients admitted to the hospital come in because of an adverse drug reaction and 5 out of 714 patients suffering from such adverse drug reaction died. This year a Task Force on Prescription Drugs of the Department of Health, Education and Welfare issued a report which called for action on a number of fronts including, among other recommendations, that H.E.W. conduct a continuing survey of drug costs and drug use, that H.E.W. provide financial support |