ORPHAN DRUGS Mr. WHITTEN. What is your estimate of the annual orphan drugs investment by the Veterans Administration and by the Department of Defense? Dr. NOVITCH. We have been unable to obtain any estimates of their annual orphan drugs investment since those agencies advise us that they do not keep data in such a way as to allow them to extract this information. APPROVAL OF FOREIGN DRUGS Mr. WHITTEN. In your professional judgment, which foreign countries have drug approval systems which are roughly equivalent to our own in assuring safety and efficacy of pharmaceutical products? Dr. NOVITCH. National drug evaluation systems vary greatly. No two are alike either in their legislation or their historical socio-economic setting. In answering your question, we can only identify foreign drug approval systems that, in terms of their legislation or published regulations, appear to be procedurally similar to our own. We cannot say definitely whether individual applications resembling INDs or NDAs are reviewed in the same way that we would review them. The countries having foreign drug evaluation systems which require the filing of applications roughly equivalent to our IND before initiating clinical investigations are Australia, Canada, France, Italy, Sweden, and the United Kingdom. The countries having foreign drug evaluation systems which require the registration or licensing of a new chemical before marketing, a procedure which seems to be roughly equvalent to the approval of an NDA, are Australia, Canada, Italy, Japan, New Zealand, Norway, Sweden, and the United Kingdom. Mr. WHITTEN. Why can't "paper NDA" policies and practices be expanded to "paper approval" of drugs already marketed in certain foreign countries? Dr. NOVITCH. The Food, Drug and Cosmetic Act requires that approval of a new drug must be based upon a request by a sponsor and the submission of specific data defending the safety and efficacy of the drug. The current provisions of the paper NDA policy were published on May 19, 1981. As explained in that notice, for duplicate new drug applications, that is ÑDAs for already approved post-1962 drug products, we will accept published reports as the main supporting documentation for safety and effectiveness, instead of original data. However, initial requests for approval must be based upon actual data. We believe that the statutory requirements are not met simply by the approval of a drug in a foreign country coupled with published reports of investigations. The paper NDĂ policy is, logically, limited to applications for drugs with which we have had experience in this country. In the absence of FDA approval of the original NDA and the acquisition of marketing experience with the originally approved drug product in the United States, we believe that paper approval of drugs based only on the fact that they have been marketed in foreign countries would place an undue risk on the American public. It would ignore the very real problems inherent in our inability to verify the qualifications of many foreign clinical investigators around the world, and our inability to treat a foreign government's approval of a new drug as being equivalent to FDA approval under the FD&C Act. FDA will accept data in support of an NDA if the data were developed in accord with FDA regulations, and if the foreign data can be verified through an FDA inspection. Betwen 1974 and 1980, FDA approved 166 new molecular entities. Of these NDAs, 84-or 51 percent-contained information from foreign studies. Of the 84, the foreign data were significant or pivotal to the approval of 29— or 35 percent of these applications involving foreign studies. Thus, we are quite willing to accept foreign studies in support of a product application, but this is not the same thing as assuming that the approval of another government means that a drug meets the standards of this country. BUILDINGS AND FACILITES FUNDS Mr. WHITTEN. Please update the table which appears on page 552 of last year's hearing regarding B&F funds. [The information follows:] Gulf Coast Technical Services Unit: Dauphin Island, Ala., roofing, painting, renovations to boat Veterinary Medicine Reearch Facility-Beltsville Agricultural Research Center: Construct chemistry lab MODULE 2 Mr. WHITTEN. What is the current status of design work for construction of Module 2? Mr. MEYER. Design work for Module 2 commenced on October 12, 1982. Because of information developed through soil borings at the site where the laboratory facilities for the Division of Veterinary Medical Research were to be constructed, the original design concept developed by the project architect in the preliminary working drawings had to be altered. The new concept will be incorporated into the architect's intermediate working drawing submission. We now expect the design of Module 2 to be complete by September of 1984. NEW HEADQUARTERS LABORATORIES Mr. WHITTEN. Please submit for the record a table which will display your plans for the phased development of new headquarters laboratories together with a schematic map showing this phased development. 4 All remaining office employees from FB-8 plus BVM 4 to 6 stories, 150,000.. office employees from Parklawn Building. 2 stories, 37,000, plus approximately 30 acres of 55 4 to 6 stories, 150,000.. 530 645 |