Fewer drugs and biologics are making it from Phase 1 trials to the marketplace, which has dramatically pushed up the cost of drug development, Acting Food and Drug Administration (FDA) Commissioner Lester M. Crawford said in a speech to a group of institutional investment analysts last month.
The FDA chief said that while historically 14% of drugs that entered Phase 1 trails eventually won approval, now 8% of these drugs make it to the marketplace, and that half of products fail in the late stage of Phase 3 trials, compared to one in five in the past. The FDA was unable to identify the source of these figures for
In his July 7 speech, Crawford also told the Banc of American Securities Healthcare Institutional Conference that filings of standard new molecular entities had fallen from 34 in 1995 to 12 last year, while original biological ...
