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commitment to move even closer and collaborate even closer than we have in the past with the Department of Agriculture.
COLLABORATION WITH USDA
We would like to stress that we already do collaborate with USDA on a wide variety of issues including the recent work that we did with biotechnology and we were very close in our relationship on those guidelines.
We are also developing a collaborative program on something that is akin to your leadership effort on orphan drugs, and these are drugs for minor species of animals.
And I have mentioned in my testimony one of the areas that we were particularly interested in and that is dealing with aquaculture. One of the concerns we have in the growing increase in food production through fish is the need to develop antibiotic and other drugs that can be useful in the farming of fish. Minor species such as trout, catfish
and others are being grown in ever larger amounts, particularly in the state that you come from, as you know, with the catfish industry there.
In the past we have focused much of our effort on drugs that are used for the major species and not developed that particular emphasis on minor species, which is akin to the orphan drug problem.
And I have introduced for the record a letter from the Delta Council that speaks to this effort of a collaborative study between Auburn, Mississippi State, LSU and the University of Illinois in an attempt to determine how we can deal with those minor species.
The focus is to develop the safe and effective antibiotics and other medicinals that will enable fish to be grown in close quarters and to be used for food.
A second area of importance in our interrelationship to Agriculture is a focus on aflatoxin, a naturally occurring carcinogenic substance in cottonseed meal. We wish to undertake a study with regard to the ammoniation process which detoxifies this cottonseed meal from aflatoxin, and we feel that this would be very important for the American farm industry as it would enable cottonseed meal which is not able to be used today to be used for feed for cattle.
This would take a substantial amount of research and again focus our collaboration between Agriculture and FDA.
ORPHAN PRODUCTS I have mentioned drugs for minor species only as an example of another emerging orphan category of future concern. Now I would like to talk about the FDA accomplishments and plans in implementing the Orphan Drug Act of 1983 in the area of human drugs.
Frank, if you would please put up the chart. I would like to summarize for your interest the growing development that we have had since the legislation has come into place and in large measure under your leadership.
Dr. YOUNG. You will note that the orphan designations have increased markedly in the past few years, and sponsor commitments to adopt orphans and concomitant with this we expect that most of the sponsor commitments will lead to orphan drugs.
You can see also that we have an active grant program which has funded 12 grants in 1983, and after that we have funded 7 additional ones. We plan to award 1.4 million for such grants in 1985 and $1.5 million in 1986.
We feel that this is a particularly important program because it enables us to give funds to investigators in universities that will stimulate orphan drug development. It is very different from NIH's general grants program in that sense.
Mr. WHITTEN. Doctor, I must interrupt you.
Yesterday we had a witness here who testified that until 1981 we had professionals in the top level of agriculture, implying that since then we have not. I don't mean to discount your interest or our interest in the fish industry, but orphan drugs to me would put human beings at the top of the list and not minor species of animals.
Also, may I advise you that the Food and Drug Administration in its total is before this subcommittee.
Dr. YOUNG. Yes, sir.
Mr. WHITTEN. Certainly with us making a fight through the years to try to get these experiments done and to get the drug houses to provide orphan drugs for human beings, I would expect that to be put first and these other things second.
Secondly, I note you have got a whole lot of new people here. I have the highest regard for them, but what happened to the old ones?
Why did they quit? The Department of Agriculture has lost most of their top people. I don't know whether it is because they differ with the Department of Agriculture or what.
I call your attention to a report last year. In our Committee report last year we said this and I hope you have time sometime to read it.
"The budget request reduced budget authority by $5 million, and proposed that this amount would be offset by establishing user fees imposed on the sponsors of new drug applications. The Committee
This opposition is based upon the clear public benefit of FDA's regulation of new drug approvals. Therefore, no resources are included in this bill for further consideration or development of a user fee proposal, and the Committee's recommendation includes restoration of five million dollars to continue the processing of new drug applications with appropriated funds."
Page 15 of this year's FDA explanatory notes has no mention of user fees as a significant item in our Committee's report in 1985. In other words, you don't consider it important unless we include this in appropriations bill language. Apparently you have not read this report.
Dr. YOUNG. Sir, I did read it in the report and in 1985 we did not include user fees in our activities. We are suggesting it again this year for your consideration.
Mr. WHITTEN. What is the basis then? Is the budget bureau telling you to do that?
Dr. YOUNG. No, sir. In looking at this, one of our feelings was that it would be most appropriate if we would be able to have funds coming from those individuals or those corporations that directly benefit from it.
Mr. WHITTEN. Well, they benefit if it works out. But this is application. With your help we are trying to push them into making application and to do the job. So you make it harder on them in that you would require fees. But the point of it is you paid no attention whatever in your recommendation here to our statement of last year and for the current year.
Are you making an effort to charge user fees today?
Dr. YOUNG. We made a recommendation, sir, in our prepared testimony to ask you when it would be possible to reconsider the addition of the same five million.
Mr. WHITTEN. If we consented and agreed to the same thing that would be all right, wouldn't it?
Dr. Young. Yes, sir.
Mr. WHITTEN. Just reconsider it, but go ahead with what we already stood for. Tell us why it is you thought our chief interest in orphan drugs was for minor species of animals as against human beings.
Dr. Young. We didn't think that your orphan drug interest was greater for small animals than for human beings, but I wanted to bring it up to show an area that had been similarly not brought forward in the past, namely the other species that that have orphan needs.
Mr. WHITTEN. I grew up loving animals. I thought you had to have a horse and a dog to live, but that doesn't mean I put them ahead of human beings.
Dr. YOUNG. And, sir, I wouldn't put them ahead of human beings either.
Mr. WHITTEN. Well you did in your testimony.
Dr. YOUNG. Because I felt I might be able to lead into showing-
Mr. WHITTEN. You thought we might be more interested in that?
Dr. YOUNG. I did and I thought it might also show a direction that we are going in the Center.
Mr. WHITTEN. You are going toward animals and away from human beings? You said you were showing the direction in which you were going
Dr. Young. In the Center for Veterinary Medicine we hope to focus on minor species.
Mr. WHITTEN. Let's talk about human beings awhile and then we'll get to veterinary medicine. Go ahead.
Dr. Young. In the orphan drug program, as I mentioned, we have felt that this has been a substantial advance and Dr. Finkel, who has led this program, is with me today and would be happy to answer any questions on this.
Mr. WHITTEN. You heard the question I asked Dr. Young, would you answer it for me?
Dr. YOUNG. Dr. Finkel?
Dr. FINKEL. Well, it's not really put ahead, Mr. Chairman. There has been a good deal of support in the agency for the orphan drug program and thanks to your Subcommittee we have been able to fund 19 grants. We feel that at least half of them have the potential for yielding new orphan drugs for the market.
Mr. WHITTEN. The charge of user fees, will that promote folks to make application or to some degree retard them?
Dr. Young. We feel, sir, that the user fees would never be applied to orphan drugs. We do not think that is appropriate, but to larger corporations in regard to all drugs we feel that it would not be a barrier. At least that is what we have been advised.
Mr. WHITTEN. And you expect us to reduce your appropriation by the amount that you collect from them?
Dr. YOUNG. We approach this in two ways. First we feel that for drug approval itself there is a great need for capital for remodeling the way we process our information and some of our facilities. It is very difficult to attract good people without that and we could use some of the user fees-
Mr. WHITTEN. I am not going to forget my question.
Would you expect us to reduce your appropriation by the amount you collected or not?
Dr. Young. We would hope that some of it would be able to be used for capital and some of it would be reduced.
Mr. WHITTEN. I repeat my question. Would you expect us to reduce your appropriation by the amount you collected from the companies?
Dr. Young. I would hope not, but that is up to your discretion.
Mr. WHITTEN. Out of about $15 million that you would collect you would hope to keep about $5 million; is that right?
Dr. YOUNG. That is correct.
Dr. YOUNG. It may have not been presented as clearly, sir, but we do hope to collect much more money than we would keep.
Mr. WHITTEN. You might proceed.
ANDA/PATENT RESTORATION ACT The next area that I would like to turn to is the ANDA patent restoration legislation. We feel that this legislation will be helpful to mankind in the sense that it will bring forward drugs that could come now out of the patent protection to the generic market.
In the first day alone under the new law received 201 applications and in the next two weeks approximately another 200 bringing us to 400 applications under the ANDA Patent Restoration law.
We have appointed a new office for this and our first drug under the ANDA Patent Restoration Act was approved on February 22.
To meet some of the concern that has been expressed over the years we have also rewritten the NDA regulations, and this NDA rewrite will streamline the new drug approval process. We feel that it will allow simultaneous rather than sequential reviews for the many disciplines, such as clinical, pharmacological, chemical, statistical and biopharmacological. We trust that these and other changes in will cut off up to 6 months, or 20 percent, in the total average FDA reviewing time for most drugs.
ANTIBIOTICS IN ANIMAL FEEDS We have also focused on another area that we feel is important and we had a legislative type hearing that Mr. Skeen was able to attend and present on animal feeds containing subthe- rapeutic amounts of antibiotics. We received on November 20, 1984, a petition for imminent hazard from the National Resources Defense Council in which they petition Secretary Heckler to declare subtherapeutic uses of penicillin and tetracyclines in animal feeds an imminent hazard. We were able to hear 36 individuals at this hearing and we are in the process of evaluating the information, that will be brought forward within the next few months.
The likely outcomes will include either the action on the imminent hazard petition itself, to approve it or deny it. Based on those actions, we will either go back to evidentiary hearings, or we will remove the administrative proceeding in its entirety, and we will keep you fully informed as this comes forward. We know that this is a very important issue.
ADVERSE REACTION REPORTING Also, returning to human drugs the NDA rewrite will bring an increased focus on adverse reaction reporting. We feel that the approval of the drug is only the beginning and the next phase really is the understanding of what occurs in terms of adverse reactions.
In that sense, we will have a greater monitoring during the first