Dr. NOVITCH. By way of quantification, in 1980 we inspected close to 47,000 different establishments, and we examined close to 27,000 samples. We also examined imported goods. Those are very often done by physical inspection at wharfside because a lot of products can be examined at one time, and for imported products it may be the first and only opportunity we have to see them. So, in 1980 we have done close to 100,000 wharf examinations, resulting in 7,000 retentions or rejections, and over 20,000 laboratory examinations. FDA COST TO EACH Dr. NOVITCH. As you can see, Mr. Chairman, the industry that we regulate is enormous in size, scope, and complexity, with products worth nearly half-trillion dollars at retail: And for all of this we calculate the cost to the individual consumer for all FDA activities is only about a dollar and a half a year. We believe that is a "best buy" for the American taxpayer. DISTRIBUTION OF FDA'S Dr. NOVITCH. For Fiscal Year 1982, Mr. Chairman, the budget request we are submitting is for $336 million and 7,400 staff years. That is detailed in the statement, but I think it is of interest to segments of that pie chart on the left represented people supportpayroll, fixed charges, such as rents, and direct operating costs. That accounted for 84 percent of our total budget in 1974. The same figure today is 10 percent higher. Ninety-four percent of our budget goes for the direct support of people, making us a very personnel-intensive operation and reducing our opportunities for extra-mural support. Only six-percent will go to extramural grants and contracts, which we require for supportive research and testing by particular experts or in unique facilities not otherwise available to FDA. Dr. NOVITCH. Finally, Mr. Chairman, last year, as you will recall, the committee and the Congress appropriated $27 million for the first phase of a very important building project at Beltsville, Maryland, a consolidation of our headquarters' animal-holding facilities, and related lab-space, replacing some of the facilities now obsolete to the point of really compromising our scientific efforts. To bring you up to date, we are nearing the final stages of the design of Module 1 and we expect to let the construction contract for it next winter. We are deferring this year's request for construction funds for Module 2, but we will certainly have those under consideration for future years and it will be an important matter for us. Mr. Chairman, that concludes my statement. My colleagues and I would be happy to take any questions you have. 77-302 (Pt. 4A) 0-81--2 NEW DRUG APPROVAL Mr. WHITTEN. Doctor, we are glad to have your statement. This committee has had some views on FDA's responsibilities, and we have been impressed from time to time as laymen and private citizens. None of us on the committee has a professional background in pharmacy, but there are two things which have become evident over the years. One is, if any other country in the world feels that their people are just as safe as ours and if they take just as much caution as we do in approving new drugs, then we on the Committee have felt that we should recognize those countries and let their approved drugs become available here. Have any steps been taken to determine which countries have human drug approval processes which are equal to ours? Have you made any study of that in order to speed up the availability of drugs which have been approved in those countries? Dr. NOVITCH. You raise two very interesting points, Mr. Chair man. Yes, we are very much interested in having harmony in drug research throughout the world. A few of us visited with the director of the Department of Drugs of the World Health Organization last year and we discovered there had never been an international conference of regulatory drug authorities. Last October, after considerable planning, FDA sponsored the first international conference of drug regulatory authorities to try to do just exactly what you are suggesting and what we agree with. [CLERK'S NOTE.-The following additional information was submitted subsequent to the hearing.] Participants at the International Conference of Regulatory Authorities, and at earlier meetings with drug regulators in developed countries, discussed ways to harmonize the requirements for testing and approval of new drugs. It was concluded that it will be a long and arduous effort to achieve the goal of an international NDA that could be submitted to, and reviewed simultaneously by, a number of countries, but a commitment was made to standardize certain testing, beginning with animal toxicity, that can speed the development and review of data internationally. At the present time FDA is familiar with the new drug approval process in most of the developed countries, and would not accept carte blanche any of their drug approvals in lieu of agency review of the data. Mr. WHITTEN. I am glad to hear that some steps are being taken. During last year's hearing, I raised a question about laetrile, if it may be useful in the treatment of cancer. A man who is facing certain death understandably, is willing to try anything, and many people would die during the time consumed by your approval process because you would not exempt certain requirements in cases of terminal illness. You describe orphan drugs on page 13 of your prepared statement. People badly need such drugs in this country but they cannot get them because there is no one interested in pursuing your approval for these drugs. It had been said that it costs $50 to $80 million to develop a drug. If it takes that much money, are not your requirements too much? Are not many people dying because you will not take it upon yourself to develop certain drugs? Can you tell phamaceutical companies if you do not develop this drug, we will? This works well in government research in many other fields. We want to explore the possibility of doing that for the |