Deregulation of Drug Development: If Effective, Can it be Safe?

Abstract

Preliminary results from the update of our survey of new drug development in nearly all (38) U.S. — owned, research-based pharmaceutical firms showed that the decline in the number of new chemical entities (NCEs) under clinical investigation which occurred in the mid-1970s, was maintained through 1979. The mean number of NCEs first taken into man in 1977–1979 was 29 per year, about half the number investigated annually in the previous decade. This decline was reflected in a reduced number of Investigational New Drug Exemption (IND) filings. In addition, the proportion of INDs filed on drugs which are self- originated (i.e., not licensed or otherwise acquired) fell to 59 % in 1979 and averaged 68 % in 1976–1979, a decline from a mean of 82 % self-originated in the previous 13 years. The trend toward initial clinical testing of drugs outside the U.S.A. appears to have diminished. The percentage of self-originated NCEs first given to man abroad, which rose in the early 1970s to approach 40 % in 1976, declined to less than 20 % in 1977- 1979. The time involved in clinical investigation of new drugs remains at the mid-1970s level of eight years Self-originated NCEs approved for marketing in 1977–1979 spent six years in the IND filing phase and two years in the New Drug Application (NDA) review phase. The success rate in U.S. drug development was approximately the same in 1977–1979 as in the mid-1970s. Eleven percent of INDs filed on self-originated NCEs prior to 1972 had reached NDA approval by the end of 1979.