Document G62kK26DMv7eq5356Md2kd5gq
Documents were not easy to get 1
Many previously un could not respond to three months of legal Hundreds of more i
released documents dis certain questions be wrangling, all search and pages of documents ar
cussed in The Journal cause information was cop>ing fees were rived over the next two *
series on drug testing not available or could waived.
months.
were obtained through not be found; the By
mid-January, Still there were few
the U.S. Freedom of In agency couldn't answer more than 1,500 pages drugs named in the
formation Act.
other questions because of FDA documents had documents. They had
Under the Act, citi they were too broad; been obtained. In many been thoroughly blotted
zens and non-citizens can request government information.
Using the act, The Journal sent its first re
and some material could not be provided because it was consid ered confidential drug
company data.
cases, the names of out by FDA officials. drugs, doctors and drug r companies involved in l the testing scandals 1
were deleted by the
quest to the U.S. Food Although the FDA FDA.
I
and Drug Administra wanted to charge $1,200 Those documents
tion (FDA) last fall.
for some material, The provided enough infor
The broad request Journal
successfully mation for another
netted only a few basic argued that release of the series of requests. This ]
documents.
documents was in the time, the requests were
The FDA argued it public interest and, after more specific.
Testing
(Continued from Page Bl)
drugs, said:
" In Canada, there is no requirement to repeat trials that are done somewhere else, provided the trials that are submitted are of good quality."
Dr. Dennis Cook, acting director general of the federal Health Department's drug directorate, said there is no system for government inspection of drug studies in humans.
He said any Canadian inspection
program will cover only laboratories
in this country. He said it is the
responsibility of foreign '
governments to inspect work done in
their own countries.
r
Ron Elliott, another federal health official, said Canada is just now developing a laboratory inspection Jj program, but as yet there is no firm j decision on when the program will
start.