The transparency of the
Australian drug approval process may be in line for a
shake up following revelations the Therapeutic Goods
Administration (TGA) is among the world''s worst offenders
when it comes to releasing information to the public.
A new study which focused on the secrecy surrounding
regulatory authorities throughout the world has found that
Australia’s TGA – unlike the US Food and Drug
Administration – does not release any information arising
from the evaluation of new drugs for market.
The study report is timely, as a special Transparency
Working Group featuring the TGA, Consumers Health Forum
and the Generic Medicines Industry Association has
proposed setting up an Australian Public Assessment Report
on the TGA website.
The study - Provision of Information on regulatory
authorities websites – looked at regulators'' websites in
the US, UK, Australia, Canada, France and New Zealand.
"Most countries release at least an assessment report. The
US FDA approval packages are the most comprehensive
documents and include extensive summaries of
toxicological, pharmacological and clinical information
provided by drug companies," study author, Agnes Vitry,
said.
In 2004, a directive of the European Union required that
national regulatory authorities make publicly accessible
meeting records and marketing authorisations together with
the assessment report and the underlying reasons for their
opinion.
"The full implementation of this directive will support
the move towards an increased transparency of European
regulatory authorities. However, this directive is not
applicable in Australia," Ms Vitry said.
Last year the TGA put a proposal to the TGA Industry
Consultative Committee (TICC) to increase transparency of
regulatory decision making. The proposal resulted in an
agreement by TICC that TGA needed to move forward with
recommendations.
According to a TGA spokesperson, the group is currently
working through options to provide public information
about the scientific and clinical evaluations that are
undertaken as part of a new medicine application.
Medicines Australia has welcomed the prospect of increased
transparency in the evaluation process for drug
registration and has been working closely with the TGA and
consumer representatives to initiate it. Reports will not
be published until after TGA approval for each product has
been granted.
Libby-Jane Charleston |
