This will contribute to invigorating clinical trials in Japan and resolving issues affecting society, such as Japan's drug lag
and device lag(1).
He points out that the Prescription Drug User Fee Act (PDUFA), by charging drug companies large fees to have their drugs considered by the FDA, has reduced the drug lag
. (See "How Have User Fees Affected the FDA?" Spring 2002.) But he also argues that PDUFA is not enough.
(22) Part of Young's approach was the promulgation of a number of new regulatory measures to deal not only with the AIDS epidemic but also the drug lag
. These regulations are outlined below, and, for reasons of space, the following analysis will focus principally on the first and the third:
As a result, this time gap between global and Japanese registration--in many cases measured in terms of years and not months or days--is now known as the 'drug lag
Other countries also are taking note of the "drug lag
" or "device lag" phenomenon occurring in Japan and making their criticisms known.
Sponsors "couldn't figure out our regulations, so that caused a drug lag
in the 1980's."
Time to approval, which now included approval of an Investigational New Drug application (for conduct of the clinical trials) as well as a subsequent New Drug application, continued to rise, reaching 6.5 years in the 1970s, 8.3 years in the 1980s, and 8.9 years for the period 1990-96 (Tufts Center for the Study of Drug Development 1998).(9) Time to approval is typically shorter by years in Europe than in the United States, and as a result drugs are often available in Europe long before they are available in the United States.(10) The difference between the time of a drug's availability in Europe and that in the United States has come to be called the "drug lag
" (Wardell 1973, 1978a, 1978b; Wardell and Lasagna 1975; Kaitin and others 1989; Grabowski 1980).
Interviewing none of the economists who study "drug lag
," he caught some Washington types unable to name unapproved drugs that could save lives.
Brody seems to proceed from the premise that reducing the demands of evidence for safety in particular but also for benefit will reduce the "drug lag
"--with attendant benefits of critically ill patients getting new drugs more quickly, and economic gains for the U.S.
Questions Pye at the PMAC, "Can the commitments made on the basis of Bill C-22 be maintained as other countries improve their patent protection?" The Drug Lag
Each new drug to be introduced onto the Canadian market has to receive HPB approval.
- To make contributions to resolving the drug lag
in Japan by developing drug products for which affiliated academic societies and other organizations deem there is a significant need.
Thirty years ago, the concerns were primarily about "drug lag
"--indolent reviews and approvals by the FDA that put Americans at a disadvantage to consumers in other countries.