Our ability to win cases greatly discouraged contests so that there were very few. I can tell you that in deciding the kinds of cases that were to be brought, we considered not the individual drug but all of the drugs involved in the particular class of the drug we were proceeding against. Mr. THOMPSON. Was there a case involving wrinkle remover? Mr. GOLDHAMMER. Yes, the wrinkle remover cases were brought in at the tailend of my career. I had a hand in the consideration of those cases. Some we won, some we lost. Mr. THOMPSON. There are still wrinkle removers on the market. Mr. GOLDHAMMER. Well, some we won, some we lost. It was a question of enforcement. a Beginning with around 1969 or thereabouts one can note sharp drop in the initiation of cases. It is far more likely that failure to enforce the law engenders disrespect for the law and widespread violation of the law to the point where when you attempt to bring about a correction you have gotten yourself into a position where you have a mountain of cases to tackle. However, that was not the situation in the early days of FDA. We kept current. As soon as the violation was encountered, if it was worthy of correction, action was undertaken, even if it meant going to trial. Having won, then it was customary for the Food and Drug Administration to issue a notice to the entire industry. There were many notices to the industry that such products would be regarded as new drugs which required new drug applications. Implicit in that notice was that failure to comply would bring action if the case were more than just of a technical violation. Mr. Chairman, I had to put that in lest we get the idea that the Food and Drug Administration was always an agency which did not act. Of course, we always considered classes, We never considered an action on a basis of an individual action. Always in our discussion was, "What are we going to do about the others?" Mr. FOUNTAIN. The subcommittee will take into account this period of time. Mr. HUTT. I must respond to that very briefly. Dr. SCHMIDT. The Defense Department looks different from how it looked in 1930. Science is so vastly different. The efficacy requirements were not implemented in 1964. Mr. HUTT. I would have to respond that I am in total disagreement with Mr. Goldhammer. It was the lack of enforcement when he was in the Food and Drug Administration that requires us today to now correct the problem that we find in the marketplace. I was in the private practice of law during the time that Mr. Goldhammer was supposedly enforcing the law. I knew as an attorney, and all of my fellow attorneys knew, that the Food and Drug Administration would talk big and do very little back in those days. That is why over-the-counter drug manufacturers marketed all these products during the 1950's and 1960's-because what they did was to look at the record of FDA. FDA was not bringing court enforcement action. They were not enforcing the law. They were letting thousands, hundreds of thousands, of over-the-counter drug products on the market, every day, Mr. Fountain, without doing anything about it. If you went and talked to FDA that is the story you got. I would, like any attorney, look at the seizure actions every month, and then I would look at the list of newly marketed OTC drugs. For every thousand newly marketed OTC drugs you might findmight, possibly find-one seizure, but it was usually not that high. So the message FDA was giving is that "We are not enforcing the law against OTC drugs." When I came to the Food and Drug Administration I decided it was time to start enforcing the law. That is why we brought about the OTC drug review, to stop the lack of enforcement which had gone on for 20 years. Dr. GOLDBERG. I have no vested interest in FDA before or after you came to the agency. Lest the record appear black and white, or white and black as the case may be, I would like to note that by just flipping through medical journals I have found new prescription drugs placed on the market without approved NDA's, and FDA seems to know nothing about them. They are regarded by FDA, as in the case of one I inquired about only last week, as new drugs put on the market without new drug applications. I am waiting to hear what kind of regulatory action FDA will take in this most recent instance. I am not persuaded the agency has been turned around from something it might have been at some other stage in its development. Mr. HUTT. If we want to get into the question of prescription drugs it raises different issues. It raises a new policy on abbreviated drug applications, when they are required, and so on, which we might want to get into in the future. To get into it today would be trying to do too much at one time. Mr. FOUNTAIN. I agree. Dr. GOLDBERG. We certainly would like to review this situation. Mr. FOUNTAIN. I agree. Referring back to the Ornex situation, I am placing in the record a copy of FDA's letter of August 8, 1972, to the subcommittee reporting the outcome of the Ornex litigation. [The letter referred to follows:] Department oF HEALTH, EDUCATION, AND WELFARE, DELPHIS C. GOLDBERG, Ph. D., PUBLIC HEALTH SERVICE, Professional Staff Member, Intergovernmental Relations Subcommittee, Committee on Government Operations, House of Representatives, Washington, D.C. DEAR DR. GOLDBERG: This is in response to your request for a status report on litigation involving the drug Ornex. I apologize for this delay. As you know, Smith Kline and French (SKF) introduced and began promotion of its new product Ornex in January 1970. When the Food and Drug Administration (FDA) discovered that Ornex was marketed without an approved new drug application, it asked Smith Kline and French for medical documentation which might support a conclusion that the drug was generally recognized as safe and effective for its labeled uses. The data supplied by SKF was evaluated as inadequate, and the company was asked to recall its stocks of Ornex from the market. When it refused to voluntarily recall Ornex and cease distribution, FDA advised the company that it would clear the market by a program of seizure actions. One seizure was accomplished on February 19, 1971.1 On February 26, 1971, SKF obtained a preliminary injunction restraining FDA from initiating further regulatory actions.2 1 United States v. An Article of Drug Orner, Docket No. 223-71, D. N.J. 2 Smith Kline and French Laboratories v. Richardson, et al., Docket No. 71-387, E.D. Pa. An appeal from the preliminary injunction was filed in the Third Circuit pursuant to 28 U.S.C. 1292(a) on the ground that the District Court lacked jurisdiction to enjoin FDA from conducting multiple seizures of an unapproved new drug under the doctrine of Ewing v. Mytinger Casselberry, Inc., 339 U.S. 594 (1950), and on the further ground that the evidence before the District Court established as a matter of law that Ornex was not generally recognized among qualified experts as safe and effective for its labeled uses and was, therefore, a new drug.3 Thereafter, while awaiting the scheduling of oral argument on the appeal, FDA on February 5, 1972, published its proposal to promulgate regulations classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. (37 F.R. 85-89.) Because the proposal recognized that adequate consumer protection and "equitable enforcement of the law requires that the agency proceed against all manufacturers of similar preparations" rather than a selected few, manufacturers of OTC drugs involved in litigation were offered an opportunity to settle the litigation by stipulating that they will abide by the OTC monographs applicable to their preparations. SKF, aware of this policy, requested that it be accorded a disposition of its case consistent with that accorded to other OTC manufacturers involved in litigation. Consequently, a stipulation disposing of the three Ornex cases has been executed. Pursuant to the terms of the stipulation, Smith Kline and French has reformulated Ornex by deleting the salicylamide and caffeine components and has agreed to make any other formulation and/or labeling changes necessary to comply with applicable OTC monographs; upon joint motion of the parties, the suit for injunction and consequent appeal have been dismissed and the injunction against FDA vacated; and, SFK having withdrawn its claim and answer in the New Jersey seizure, the seized stocks have been condemned under a default decree. A copy of the stipulation is enclosed. If we may be of further assistance, please let us know. Sincerely yours, GERALD F. MEYER, Office of Legislative Services. Mr. FOUNTAIN. The mechanics of the trade out is suggested by this passage in FDA's letter: Because the proposal recognized that adequate consumer protection and "equitable enforcement of the law requires that the agency proceed against all manufacturers of similar preparations" rather than a selected few, manufacturers of OTC drugs involved in litigation were offered an opportunity to settle the litigation by stipulating that they will abide by the OTC monographs applicable to their preparations. SKF, aware of this policy, requested that it be accorded a disposition of its case consistent with that accorded to other OTC manufacturers involved in litigation. Consequently, a stipulation disposing of the three Ornex cases has been executed. Mr. HUTT. Who signed that letter, Mr. Fountain? Mr. FOUNTAIN. Gerald F. Meyer. Mr. HUTT. This was not Mr. FOUNTAIN. August 8, 1972. Mr. HUTT. This was not the letter to the company actually containing the stipulation? Dr. GOLDBERG. This was an explanation to the subcommittee in response to our request as to what the outcome had been. Mr. HUTT. All right. Mr. FOUNTAIN. Since 1971 this subcommittee has brought to the attention of FDA a number of complaints from both industry and consumers about misbranded drugs on the market, as well as new drugs on the market without approved NDA's. For 3%1⁄2 years FDA has told the subcommittee that no action would be taken, despite the misbranding or new drug violations, until after the monographs 3 Smith Kline and French Laboratories v. Richardson, et al., No. 71-1484. had been published and had become effective. Presumably those violative products are still on the market, and immune from FDA action for an indefinite period-probably years. Is that right? Mr. HUTT. I do not think for years. These undoubtedly were products which were not either patent frauds or health hazards, and therefore they fit into the general category of literally 200,000 products, all of which must be reformulated and relabeled at some point in time. The question again is, do you take some out of turn? Is there good reason to do that or do you handle all on a scheduled systematic basis? Mr. FOUNTAIN. I can, of course, appreciate the tremendous problem you have with respect to these over-the-counter drugs by the thousands, many of which have been on the market for many, many years. However, I find, at least from my point of view and based upon the information I have, and that is the way we have to form our opinions, I find it disturbing that FDA now appears to have extended its moratorium on enforcing the new drug provisions from OTC drugs to prescription drugs. The subcommittee recently inquired about a number of prescription drugs on the market without NDA's. We received a reply with two enclosures dated March 28, 1975. I am placing in the record the letter from FDA and one of the enclosures. The other enclosure appears at pages 91-92. [The documents referred to follow:] DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Hon. L. H. FOUNTAIN, PUBLIC HEALTH SERVICE, Chairman, Subcommittee on Intergovernmental Relations and Human Resources, Committee on Government Operations, House of Representatives, Washington, D.C. DEAR MR. FOUNTAIN: This is in response to the telephone request of February 20, 1975, by Mr. Goldhammer, Consultant to the Subcommittee, for information on several drugs. Enclosed is the data requested by Mr. Goldhammer on the following drugs: Triafed Allerphed Triacin Allerfin Action C Also enclosed are Federal Register publications referenced in the attachment from the Bureau of Drugs as well as correspondence between the Agency and Burroughs Wellcome and Company on this matter. If we can be of further assistance, please let us know. Sincerely yours, Enclosures. ROBERT C. WETHERELL, Jr., Director, Office of Legislative Services. DRUG STATUS 1. Are the identified drugs prescription or over-the-counter (OTC) drugs? The listed drugs, Triafed, Allerphed, Triacin, Allerfrin, Triprofed, Action, Action C. Actacin, and Actacin C are all prescription drugs. 2. Are these drugs subject to new drug applications (NDA's)? While they are subject to the NDA requirements, we have permitted such products to remain on the market under the aegis of the prime NDA until such time as final resolution is made. Consequently, we have not taken action against products under this category pending completion of separate reviews by the OTC Panel on Cold, Cough, Allergy, Bronchodilators and Antiasthmatic Drugs and the FDA Advisory Committee on Drugs Used in Allergy, provided that they meet the requirements for continued marketing as described in the Federal Register notice of December 14, 1973. Please see the Federal Register announcements of May 15, 1973, December 14, 1973, and the incoming letter from Burroughs Wellcome and our response to same, attached, which goes into more detail in this matter. 3. Are these drugs listed under the Drug Listing Act? Of the drugs mentioned above, only Action marketing by Michigan Pharmacal, and Actacin marketed by Diacin Chemical Company, are regarded to be in compliance with the provisions of the Drug Listing Act. A compliance program specifically designed to assure compliance with the Drug Listing Act by all drug firms marketing human drug products will issue shortly. DEPARTMENT OF HEALTH, EDUCATION, AND Welfare, PUBLIC HEALTH SERVICE, Mr. CLEALAND F. BAKER, Burroughs Wellcome & Co., 3030 Cornwallis Road, Research Triangle Park, N.C. DEAR MR. BAKER: This is in reply to your letter of January 31, 1975, expressing your concern regarding the marketing of products similar to Actifed and Actifed C preparations without clearing FDA's "regulatory procedures." At the present time the ingredients found in your products (triprolidine HC1 and pseudoephedrine HC1) are being reviewed by the OTC Panel on Cold, Cough, Allergy, Bronchodilator and Anti-Asthmatic Drugs and an FDA Advisory Panel on drugs used in allergy. As you probably know there are a number of ingredients present in both OTC and prescription cold, cough and allergy preparations currently being marketed. Appropriate formulation and labeling of OTC drugs for these uses as well as the division between OTC/Rx is being considered in detail since the final OTC monograph which emerges from this review will have a substantial bearing on the formulation and labeling of Rx as well as OTC drugs used for these purposes. FDA policy in this regard was published in the Federal Register of May 15, 1973, (copy enclosed) which specifies the interim guidelines for the formulation and labeling of prescription drugs intended for cough and allergy purposes pending the OTC drug monograph. On the basis of public hearings held on June 4, 1973, the Commissioner concluded that it was premature to adopt guidelines on the labeling of these prescription drugs. Since the issues involved in the OTC drug review are so closely related, and sound medical practice requires consistent formulation and labeling for these two types of products, it is essential that they both be subjected to new requirements at the same time. The Commissioner submitted the full record of the hearing for the prescription products to the OTC advisory review panel for its consideration in preparing its report on this category of drugs. In view of the above, the Commissioner concluded it was appropriate to add currently marketed prescription cough and allergy preparations similar to or containing ingredients also in OTC cold, cough or allergy products to the list of drugs which may remain on the market beyond the applicable time limit for implementation pending review of all relevant scientific data for the OTC drug products. Please see the enclosed Federal Register notice of December 14, 1973. Thus, at the present time, a firm may market a product falling under the scope of this drug category as follows: 1. In addition to the usual mandatory labeling requirements the current labeling should bear the required disclosure of drug efficacy study evaluations in the labeling and advertising as set forth in Regulation 21 CFR 3.81. 2. A firm which does not wish to disclose the drug efficacy study evaluation as required by 21 CFR 3.81 may follow the proposed interim guidelines, per Federal Register announcement of May 15, 1973. While this exemption does not apply to certain ingredients as listed therein, the guidelines do provide for the interim marketing of a product which contains an antihistamine and a nasal decongestant limited for use for the treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis, subject to review under the ongoing OTC study of such products. We note that the proposed interim guideline of May 15, 1973 does not permit the_marketing of preparations offered for cough containing antihistamines and oral decongestants such as found in Actifed-C. |
