1 medically useful drug, he shall designate for such drug an 2 official name which he has determined to be useful. 3 4 "(d) After each such review, and at such other times as the Secretary may determine to be necessary or desirable, 5 the Secretary shall cause to be compiled, published, and pub6 licly distributed a list which shall list all revised official names 7 of drugs designated under this section and shall contain 8 such descriptive and explanatory matter as the Secretary may 9 determine to be required for the effective use of those names. 10 "(e) Whenever the Secretary has designated under this 11 section a revised official name for any drug and that name 12 has been published in any list compiled under this section, 13 such name shall for all purposes of this Act be the exclusive 14 official name of that drug. 15 "(f) The amendments made by this section shall take ef16 fect on the first day of the month beginning after 17 the date of enactment of this Act. 18 "SEC. 510. (a) The Secretary shall cause to be com19 piled, published, and publicly distributed annually, and at 20 such other times as the Secretary may determine to be neces21 sary or desirable, a list of drugs having the potentiality of 22 particularly serious dangerous or harmful effects and may 23 include in that list such information relating to those dan24 gerous or harmful effects as the Secretary may consider in the best interest of the public health. 25 1 "(b) The Secretary shall publish in convenient and 2 readable form and shall distribute on a current basis to 3 physicians, hospitals, medical and nurse-training schools, 4 depository libraries, and Federal, State, and local govern5 ment offices concerned with the handling and utilization of 6 drugs true and correct copies of all printed matter which the 7 Secretary has required to be included in any package in 8 which any drug is distributed or sold." (From Drug Trade News, May 1, 1961) Kelly, PMA Counsel, Analyzes Kefauver-Celler Bills The Kefauver-Celler bill to impose new controls on the pharmaceutical industry has been referred to Senate and House Judiciary Committees. Identical measures, they have been designated as S. 1552 by Sen. Estes Kefauver (D., Tenn.) and H. R. 6245 by Rep. Emanuel Celler (D., N.Y.). The following analysis of the bills has been prepared by John T. Kelly, legislative counsel to the Pharmaceutical Manufacturers Assn.: Section 1. This is the enacting clause and the short title. Sherman Act Amendments Section 2. This section would add a new section 7 to the Sherman Act. It provides that any contract, combination or conspiracy concerning drugs violates sections 1 and 3 of the Sherman Act if any party to such arrangement agrees to: (1) Withdraw or cause to be withdrawn any pending patent application; (2) Concede to another patent applicant priority of invention on condition that the royalties on such patent are divided among such applicants to favor applicants of the patents over nonapplicants through more advantageous royalty rates, or to license only persons who are applicants for the patent; New section 7 does not apply to a sale and assignment of the property right in a patent application. Amendment Of Patent Laws Section 3. Section 3 of the bill amends sections 100, 101, 135 and 154 of title 35 of the U.S. code, all relating to patents. Section 3(a) of the bill adds to 35 U.S.C. 100, which defines various patent law terms, a definition of the term "drug" as it is in section 201 of the FD&C Act, except that "drug" as used in the bill is limited to prescription drugs. Section 3(b) of the bill adds new provisions to 35 U.S.C. 101 which fixes the bounds of patentable inventions. Section 3(b) provides that a molecular or other modification of an existing drug or combination of two or more existing drugs is not patentable unless the HEW (Health, Education and Welfare Dept.] Secretary has determined that the therapeutic effect of such modified drug or combination of drugs is significantly greater than the therapeutic effect before modification or combination. Section 3(c) of the bill would amend 35 U.S.C. 135, which provides for an interference procedure in the Patent Office when the Commissioner of Patents feels a patent application interferes with a pending application. This section would also make the patent on a new drug issue as of its effective date. Drugs not requiring a new drug application would have the date of the filing of the patent application established as the patent's effective date. Section 3(d) of the bill amends 35 U.S.C. 154, which gives to patentee exclusive rights to the invention for a period of 17 years from issuance of the patent. Section 3(d) would now limit the exclusive rights of a patentee of a drug patent to a period of three years from the date of filing the application. For the remaining 14 years, the patentee would be required to grant an unrestricted license to each qualified applicant. However, if the patentee does not grant a qualified applicant a license within 90 days after application, the patentee must report such patents. The Commissioner may then, on the basis of such report, or after determination, terminate the patent. publishing notice of such termination in the Federal Register and endorsing it on subsequent copies of the patent distributed by the Patent Office. The term "qualified applicant" means one who holds an unsuspended and unrevoked license from the HEW Secretary to manufacture that particular drug (see section 508 of this bill). The term "unrestricted license" includes a grant of technical information required for the sale and efficacious manufacture of the particular drug. It excludes all limitations or restrictions on the manufacture, use, or sale of such drug, other than the payment of a royalty not exceeding 8 percentum of the gross selling price received by the licensee for the sale of such drug. Food, Drug And Cosmetic Section 4. Section 4(1) of the bill amends section 201(p)(1) of the FD&C Act, defining the term "new drug" by (1) in erting after the words "to evaluate safety." the words "and efficacy"; and (2) inserting after the words "as safe." the words "and efficacious." Section 4(3) of the bill would prohibit as adulterated or misbranded any prescription drug introduced into interstate commerce by any producer who did not have an unsuspended and unrevoked license as required by section 508 of this bill. Section 4(4)(b) adds the following label requirements: (1) The manufacturer's license number. which he must obtain from HEW Secretary under sec tion 508 of the bill; (2) A statement of the quantity of the package contents; (3) The official name of the drug in type as large and as prominent as that used for any brand name appearing on the label; and (4) The date after which the drug cannot be expected beyond reasonable doubt to produce its intended specific results. Section 4(5) would declare mis branded any drug made from tw or more ingredients unless the label bears the official name and quantity of each active ingredient. Section 4(6) of the bill subjects all antibiotic drugs to the same labeling requirements now specified for certain antibiotic drugs named in the law. Section 4(7) adds two new paragraphs to section 502 of the FD&C Act dealing with misbranding: (1) The manufacturer would be required to include in information sent by mail to doctors a true copy of all printed matter which the HEW Secretary has required to be included in the package in which the drug is sold. (2) The manufacturer of a new drug will be required to furnish to doctors the information included in package inserts. Section 4(7) (m) (2) of the bill would also require all advertisements and other printed material issued by the manufacturer of the new drug to include its official name, a warning approved by the HEW Secretary as to any danger ous or harmful effect and a full and correct statement of the drugs efficicacy. Section 4(8) (10) of the hil amends section 505 of the FD&C [Food, Drug and Cosmetic] Act as to application for approval of nes drugs by adding efficacy of the drug to the tests of strength, quality and purity now required by the law. Section 4(9), of the bill would enable the HEW Secretary to defer the effectiveness of the new drug application until he has determined that it is safe for use and efficacious in use and has so notified the application. Section 4(12) amends section 507 of the FD&C Act by extending it to apply to any other antibiotic drug. Licensing Of Producers Section 4(13) of the bill adds a new section 508 to the FD&C Act. This new section relates only to drugs which are required to be dispensed on the prescription of a physician. Paragraph (a) of new section 508 would provide that any person manufacturing or preparing a drug or drugs for distribution in interstate commerce or for importation into this country must obtain a license from the HEW Secretary to do so. If the Secretary finds that such person is not qualified to make such drugs or has adulterated or misbranded them, he shall suspend or revoke the license. This paragraph also prohibits the production of such drugs unless the producer has an unsuspended and unrevoked license. This also applies to imports of foreign drugs. Paragraph (b) would provide that no license would be granted unless the applicant shows that the establishment in which the drug is to be produced meets such standards as the HEW Secretary shall determine to be necessary to insure the continued chemical structure. strength, quality, purity, safety and efficacy of the drug. Such license shall be revoked or suspended if the Secretary determines that the establishment cannot meet his standards. Paragraph (c) would give to HEW employees the right to enter and inspect any such establishment. The inspection may include, but is not limited to, commercial testing laboratories, plant sanitation, raw materials and analytical reports on such materials, formula cards, actual manufacturing working sheets, batch records, weighing and measuring controls, packaging techniques, sterility controls, potency controls, coding systems, facilites for maintaining separate identity for each drug, cleaning of equipment between batches, quarantine of drugs until after clearance with the control laboratory, qualifications of the technical staffs and the complaint file of the licensee or applicant for license. Paragraph (d) provides that no license may be granted when the drug is manufactured, prepared or propagated in a plant in a foreign country unless the Secretary has determined that adequate and effective means are available to determine from time to time that the plant continues to fulfill the requirements under paragraph (b) with respect to that drug. A license of a foreign plant shall include compliance with the provisions of the Food, Drug and Cosmetic Act, as amended by this bill and any other conditions which the Secretary determines necessary for the protection of public health and safety. Paragraph (e) provides for a public hearing upon objections by an applicant or licensee for a refusal to license or the suspension or revocation of a license within 30 days after notice by the Secretary of such action by him. Evidence must be received on issues raised by the objections. The Secretary then as soon as practicable shall enter his final order supported by his finding of fact and his conclusions. No final order suspending or revoking a license shall take effect until 90 days after its publication, unless the Secretary finds that emergency conditions exist which necessitate an earlier date. In that case such conditions shall be specified in his order. If the Secretary finds the requirements for a license are being violated he may immedi ately on notice to the licensee suspend the license. Paragraph (f) provides for an appeal from a final order of the Secretary to the United States Court of Appeals for the circuit |