- © 2004 Canadian Medical Association or its licensors
The recent Canada–US agreement to share pharmaceutical regulatory information may be a sensible way to pool resources but has some potential problems, says an expert in pharmacology.
Health Canada and the US Food and Drug Administration (FDA) signed a Memorandum of Understanding for Closer Collaboration in November that allows them to share pre- and postmarket information, including evaluations of efficacy and data on adverse reactions. The aim, according to a Health Canada statement, is to develop a more efficient therapeutic evaluation process and more rapid access to new therapies to “enhance [Health Canda's] regulatory performance.”
Dr. Jim Wright, a specialist in pharmacology at the University of British Columbia, says that given Canada's relatively small population, it makes sense to share information — particularly evidence of adverse events — with other countries. “We're all trying to answer the same questions, so why not share the expertise?”
But Wright is concerned about the potential implications of the FDA's ties to the pharmaceutical industry. “Their whole review process is funded by the industry. If we're going to use [that data] then I have concerns.”
However, if collaboration gives Canada more clout in requiring industry to do “proper postmarketing randomized controlled trials, I'd be in favour,” he said. (See also CMAJ 2003; 169 [11]: 1170-1.)
In an interview with CMAJ, the director general of Health Canada's Therapeutic Products Directorate declined to elaborate on what collaboration would ultimately mean. However, Dr. Robert Peterson emphasized that a more cooperative regulatory environment would enhance and hasten the regulatory process “without compromising issues associated with safety.”
The signing follows an infusion of $190 million into the directorate, to accelerate reforms. — Louise Gagnon, Ottawa, and Barbara Sibbald, CMAJ