Transparency in drug regulation: Mirage or oasis?
CMAJ, 171 (23):
1363 (2004)Abstract
In Canada, the information used to approve new drugs is deemed commercially
sensitive and hence confidential under the Access to Information
Act,1 and the Therapeutic Products Directorate (TPD) will not release
such information without the manufacturer's approval. As a consequence,
safety and efficacy information contained in unpublished trials submitted
to the TPD is generally unavailable to researchers, physicians and
patients, a situation that can potentially lead to the inappropriate
prescribing and use of medications.