of Therapeutics) state "Great care should be observed that these capsules are swallowed whole, for contact of the chemical with the oral mucous membrane may cause painful ulceration." The purpose of the tough gelatin coating specified by the Pharmacopoeia is to prevent users, particularly children, from chewing pills, thus releasing the drug in the mouth. New York District was unaware of the significance of the pharmacopœial requirement for the coating when it reported the samples in question. We have now informed that district of the importance of this requirement so that in future instances attention will be given to this detail. You will be interested in knowing also that we are in receipt of a letter from the director of Revision of the Pharmacopoeia stating that consideration is being given to providing a more definite specification for the coating than is represented by the word "tough." Very truly yours, (s) John L. Harvey, Associate Commissioner of Food and Drugs. Mr. HARVEY. I do so identify it and I agree that statement is in there. Mr. BROWNSON. I wonder if Mr. Preu will take the stand again at the other side of the table and if you will just remain there, Mr. Harvey. Mr. Preu, when you received this notification included in the letter which we have just included in the testimony as exhibit No. 8 at FOA, what did FOA do as a result of this notification from the Food and Drug Administration advising that the coating was not satisfactory? Mr. PREU. On July 24, 1952, Mr. Hingher sent to the mission in Indochina a copy of the letter from the Food and Drug Administration dated July 8, 1952. Mr. BROWNSON. I ask unanimous consent to introduce into the record exhibit No. 9 which is a copy of the letter of July 24 addressed to the Honorable David Williamson, Chief, United States Special Technical Mission, American Embassy, Saigon, Vietnam, which has been previously identified by Mr. Preu, and has been established that no deliveries under the second contract for one million and a half pills of hexylresorcinol had been made up to this time. (Exhibit 9 is as follows:) Hon. DAVID WILLIAMSON, EXHIBIT 9 JULY 24, 1952. Chief, United States Special Technical Economic Mission, DEAR MR. WILLIAMSON: The attached copy of a letter was received from the Food and Drug Administration in response to our request that a careful recheck be made of the coating on hexylresorcinol pills supplied to the Government by Retort Pharmaceutical Company. Our records show that contract GS-OOP16436 was shipped to Indochina. It is suggested that, if possible, administration of the pills be carefully supervised and instructions issued that the pills be swallowed whole to prevent injury to the oral mucosa. Sincerely yours, Attachment. W. H. HINGHER, Special Consultant, Medical Supply. Did FOA take any action to hold up any future deliveries under this contract after you discovered the unsatisfactory condition of the pills on the first contract? Mr. PREU. Mr. Chairman, I am informed that the records in FOA reveal no documentation on this point but that Mr. Hingher telephoned GSA with a request that deliveries be stopped, if possible. Mr. BROWNSON. After the shortcomings in the original contracts were brought to the attention of your agency, were any other hexylresorcinol contracts entered into between GSA and the Retort Pharmaceutical Co. ? Mr. PREU. The FOA organization issued two procurement authorizations for a variety of drugs. In both of these procurement authorizations were requests for hexylresorcinol pills in small amounts. I am informed, also, that GSA issued contracts under these two procurement authorizations which included hexylresorcinol pills. Mr. BROWNSON. I would like to insert into the record at this point exhibit 11, which is a GSA invitation to bid and award, the details concerning contract of October 9, 1952, and exhibit 12, the same information concerning contract dated December 18, 1952. (These exhibits are set forth in the appendix, see pp. 139-162.) Did you have Food and Drug inspect hexylresorcinol pills under these new contracts? Mr. PREU. It is my understanding instructions were given GSA and they were inspected. Mr. BROWNSON. Do you know whether they met the requirements? Mr. PREU. I believe the tests-and in fact there were 3 or 4 testsshowed in each case that they did not meet the U. S. P. requirements. Mr. BROWNSON. The information that the subcommittee staff has provided indicates they were rejected on four different occasions? Is that essentially correct? Mr. PREU. I believe that is correct. Mr. BROWNSON. Now, what steps has FOA taken to cancel these contracts? Mr. PREU. On July 8, 1953, Mr. Hingher sent a memorandum to the General Services Administration asking that the last two contracts for hexylresorcinol pills be canceled. Mr. BROWNSON. I will ask unanimous consent that exhibits 13, 14, 15, and 16 be included in the record. These are records of the four rejections of the pills supplied by the Retort Pharmaceutical Co. (These exhibits are as follows:) EXHIBIT 13 T-NY-513 Hexylrescorcinol Pills Mr. S. G. MORGAN, RETORT PHARMACEUTICAL CO., INC., 42-25 9th Street, Long Island City, N. Y., December 10, 1952. Chief, General Services Administration, Inspection Division, Federal Supply Service, 250 Hudson Street, New York 13, N. Y. DEAR SIR: Analysis has been completed on a sample identified as follows: Product complies with U. S. P. requirements for assay and identification. The pills however do not comply with the U. S. P. requirement "are covered with a tough gelatin coating." The coating on these pills is not tough but is easily chipped off with a thumb nail. Yours very truly, Enc: 6 copys this letter with Form 84 (2). cc: Ad. F. C. SINTON, Acting Chief, New York District. EXHIBIT 14 RETORT PHARMACEUTICAL CO., INC., T-NY-541 Hexylresorcinol Pills Mr. S. G. MORGAN, Chief, General Services Administration, Inspection Division, Federal Supply Service, 250 Hudson Street, New York 13, N. Y. DEAR SIR: Analysis has been completed on a sample identified as follows: Sample: Hexylresorcinol Pills Contract: GS-03-P-65 (EC) Lot No.: K2-2292A Product fails to comply with U. S. P. requirements for assay. The U. S. P. requires that Hexylresorcinol Pills contain not less than 91 percent and not more than 109 percent of the labeled amount of Hexylresorcinol. Our examination shows not more than 85.6 percent of the labeled amount. The U. S. P. further requires that Hexylresorcinol Pills be covered with a tough gelatin coating. The pills apparently do not conform in this regard. Our Washington laboratories also failed to get a positive test for gelatine in the coated pills. Incidental to the above examinations, our Washington laboratories noted that the pills were quite resistant to synthetic gastric juice as well as to saturated sodium carbonate solutions. They consequently wondered if the pills would be absorbed after ingestion. Some of the pills were given orally to dogs, and it was found that they were apparently disintegrated and absorbed. Very truly yours, F. C. SINTON, Acting Chief, New York District. Enc. 6 carbon copies this letter (with 2 carbon copies Form 84 (2)). EXHIBIT 15 T-NY-560 Hexylresorcinol Pills Mr. S. G. MORGAN, RETORT PHARMACEUTICAL CO., INC., Long Island City, N. Y., July 8, 1953. Chief, General Services Administration, Inspection Division, Federal Supply Service, DEAR SIR: Examination has been completed on samples of Hexylresorcinol Pills identified as follows: Sample: Hexylresorcinol Pills (T-NY-560) Contract: GS-03P-65 (EC) Lot No: K2–2292–3 Sample: Hexylresorcinol Pills (T-NY-561) Contract: GS-03P-287 (EC) Lot No: K2-2292-4 In addition to exminations made in New York, subsamples were also submitted to our Washington Laboratories who have confirmed our findings and conclusions. We find that the coating tends to crack under pressure and is quite inflexible. Hence it is the opinion of our Washington Office that this coating does not conform to the U. S. P. requirements of a "tough gelatin coating," since "tough," according to Webster's Collegiate Dictionary means "Strong or firm in texture but flexible and not brittle." In addition, the pills have a strong odor of formaldehyde. There is no U. S. P. provision for the use of formaldehyde, and its presence is considered undesirable. In view of the foregoing it is our conclusion that the pills do not conform to U. S. P. requirements even though satisfactory as to assay and identify. Yours very truly, F. C. SINTON, Acting Chief, New York District. Enc: 5 cc this ltr. with form GSA #342. EXHIBIT 16 In reply refer to: FSI-2. Chief, Examination Branch, Attention: Mr. E. Keith. MARCH 1, 1954. Chief, Section 2, Inspection Branch, Central Office, Washington, D. C. Retort Pharmaceutical Company, Inc. Subject material has been sampled, analyzed, and rejected four times. While the cost of the first analysis is for the account of the Government, subsequent analysis costs on replacement material should be borne by the contractor. You have already been advised of the charges for the second ($80.50) and third ($31.50) tests. The fourth analysis has been reported by the Food and Drug Administration to be $87.50 (171⁄2 hours at $5.00 per hour). This fee along with the others previously mentioned should be deducted from contractor's account. For your information, this firm is currently supplying pharmaceuticals to the Government under contract GS-03P-2203. cc: Master Reading File. Mr. BROWNSON. You said, I believe, that you directed a memorandum to Mr. Hinger, and he in turn directed a memorandum dated July 8, 1953, to the Emergency Procurement Service, GSA, requesting cancelation of the last two contracts. Will you identify exhibit No. 17 as that memorandum and read some pertinent paragraphs from it please? (Handing paper to witness.) (Exhibit 17 is as follows:) EXHIBIT 17 JULY 8, 1953. Mr. Boв Ross, Liaison Officer, EPS, GSA. W. H. HINGHER, IND, MSA. Hexylresorcinol Pills. Referring to PR 84-370-99-990-3516, Item 6, for 4,080 boxes hexylresorcinol pills, USP, we have been informed that the contractor, the Retort Pharmaceutical Company, has had several rejections of pills submitted for compliance with pharmacopoeial requirements. In view of the history of the same commodity furnished by Retort Pharmaceutical Company and shipped to Indochina, it is requested that this contract be cancelled or the contractor declared in default and the material obtained from another source. If you will check with the Inspection Division, you will find representative lots of pills shipped to Indochina have been re-examined by the Food and Drug Administration and their report shows that the administration of the pills to humans would involve considerable risk of phenol burns in the mouth of the patient due to the fact that the pills are not properly tough gelatin coated. PR 93-370-00-201-3048 also specifies 30,000 boxes of hexylresorcinol pills, and the same conditions apply to this shipment. As the pills are urgently needed for Public Health programs, it is requested that awards be made to a reliable contractor and shipments forwarded with a minimum of delay. Mr. PREU. I so identify it. The second paragraph says that in view of the history of the same commodity furnished by the Retort Pharmaceutical Co. and shipped to Indochina, it is requested that this contract be canceled or the contract declared in default and the material obtained from another source. It also states that lots of pills shipped to Indochina have been reexamined by the Food and Drug Administration and the report shows that the administration of the pills to humans would result in considerable risk of phenol burns in the mouth of the patient, due to the fact the pills are not properly tough gelatin coated. Might I add a comment at this point? Mr. Hingher requested from the mission samples of the first two lots involving the 3 million vials, which were received, tested by Food and Drug Administration, and declared not to be in compliance with the United States Pharmacopoeia, and I think that is the reference in this third paragraph that I just read. Mr. BROWNSON. Do you know as a result of that memorandum whether the contracts in question actually were ever canceled? Mr. PREU. Mr. Chairman, because of our relations with General Services Administration, where they have full authority to procure, we do not have in our records information as to whether GSA followed our instructions. I did have our records checked and found no supplier's certificate indicating payment under those two contracts. Mr. BROWNSON. That is a question we should direct to GSA. Mr. PREU. Yes, sir. Mr. BROWNSON. Mrs. St. George, do you have any questions for either witness at the present time? Mrs. ST. GEORGE. I have no questions. Mr. HOLTZMAN. I have a statement to make. In Mr. Hingher's letter which is exhibit No. 4, I frankly do not see how any public servant could do anything other than he did in calling the attention of GSA to the problem and stating as the proper coating of these tablets is of the utmost importance, it is urgently recommended that inspection be made by the Food and Drug Administration. In my opinion, more than that no man could do. Of course, we have the additional problem here of the United States Pharmacopoeia not making provision for such a test. I want to compliment Mr. Harvey for doing the only thing that an able, competent administrator could do; but it seems to me that letters of this sort should be reproduced when they go out to the regional office, and if a letter of this kind went out to the regional office from Food and Drug, I frankly do not see how there could be any excuse for failing to check carefully and adequately the coating on these pills. Mr. WILLIAMS. I have a question to ask following that. I wonder if Mr. Harvey knows what the nature of the request to your Administration was for an examination of the pills. Was it a letter or how did the request come? Mr. HARVEY. I understand it was a letter from the GSA regional office at New York to my regional office. I have not seen it. I asked the question of my New York man and he said that they were requested to make the examination called for by the USP. Mr. BROWNSON. In other words, if the letter had been forwarded to you, you probably would have paid more attention to the coating? Mr. HARVEY. I think that is a reasonable assumption. Mr. BROWNSON. It seems to me as if this is a case where bureaucracy was on the side of the worms. There being no further questions, we will excuse these two witnesses. We appreciate very much their frank cooperation and testimony. I will ask Mr. James C. Crothers, Director, Business Service Center, General Services Administration, to take the stand. 55430-54-3 |