The Honorable Estes Kefauver/7 August 8, 1961 mistake to set up a licensing system unless the administrative agency involved is equipped to handle it effectively and unless there is assurance that the appropriations for the agency would be much more adequate than they have been in the past. 4. Dissemination of Information on Drugs. A prime objective of the bill is to encourage dissemination of more accurate and complete information on drugs to physicians and hospitals. We favor proposals directed toward this objective, particularly those which would require disclosure of side effects, contra indications, and toxicity. Under a new Section 510, the Secretary would publish and distribute generally a list of potentially dangerous drugs or those with harmful effects. Circulation of such information to hospitals would be helpful. We note, however, that there is already in existence, under the auspices of FDA, a program for reporting by hospitals of adverse effects of drugs. We would question the desirability of general distribution of a list of dangerous drugs. The lay public is not capable of assessing information dealing with toxicity and harmful effects of complex drugs. The effect might be to mislead rather than to inform. Subsection (b) would require a general distribution to physicians and hospitals, in convenient and readable form, of all printed matter distributed with a drug. The present practice of some hospital pharmacies is to file package inserts accompanying drugs dispensed in hospitals. These inserts vary in size and shape, and are not easy to compile for ready reference use. A compilation in convenient form of information on drugs according to trade name would be a helpful supplement to the Hospital Formulary System. 5. Extended Certification. We favor the amendment to Section 507 which would extend the certification of antibiotic drugs from those specifically named when the law was passed to all antibiotics. If the certification procedure has merit for some antibiotic drugs, it has merit for all. 6. The Patent Provisions. Our comments are limited to the effect these provisions may have on the Hospital Formulary System. We think it is reasonable to restrict patents to those drugs which produce new pharmacological effects, as the bill proposes. This should be a major contribution to rational drug therapy. We believe such a proposal is essential to the effective working of a system of generic terminology which is basic to the Hospital Formulary System. To the extent that patents are confined to drugs having new pharmacological effects, there will be a wider field in which generic terms can have impact and increased opportunities for hospitals to purchase drugs by generic names. In conclusion, we would like to emphasize the need for appropriating sufficient funds to enable the Food and Drug Administration to keep pace with its responsibilities in protecting the public health and welfare under the Federal Food, Drug and Cosmetic Act. We would appreciate this letter being made a part of the record of the hearings on S. 1552. Sincerely yours Kenneth Williamson Associate Director American Hospital Association KW/jw Pharmaceutical Manufacturers Association (SUCCESSOR TO AMERICAN DRUG MANUFACTURERS ASSOCIATION AND AMERICAN PHARMACEUTICAL MANUFACTURERS' ASSOCIATION 335 Howard Avenue Austin Smith, M.D., President Pharmaceutical Manufacturers Assoc. 1411 K Street, N. W. Washington 5, D. C. Dear Dr. Smith: This is in reply to the letter of August 17, 1961, from Mr. Kloepfer of the PMA staff. In it he advised me that a question had arisen as to whether additional data was needed in order to provide to the Senate Subcommittee on Anti-Trust and Monopoly a more complete statement relative to the discovery and development of prednisone. As you know, as Senior Librarian at Squibb, I served as chairman early in 1960 of a 3-member committee which was requested by the Pharmaceutical Manufacturers Association to compile information on the origin of significant drugs. The report of our committee was offered by you as an exhibit at Page 10844 of the Anti-Trust Subcommittee's hearings on administered prices in the drug industry. The reference to prednisone in that exhibit indicated that Syntex of Mexico was the "discoverer" and that Schering Corporation was the "developer" of this product. The source for this entry was the 7th edition (1960) of The Merck Index, Page 849, which read in part as follows: "Prednisone... Structure: Herzog et al. (Schering It would be desirable that the official record of the hearings indicate that the application for a patent on prednisone is the subject of an "interference", as is correctly stated at Page 121 of the report issued this year by the Subcommittee on its drug industry investigation, which reads: "As of early 1961, however, this product was still Sincerely yours, Thinifred Sewell Winifred Sewell |