The following is Part 3 of Lee Smith’s story about her struggle for the approval of Herceptin in Canada. Go back to Part 1. Go back to Part 2.

February 24, 2000

Is it at all possible that we have made a difference? Could it be that the fight for approval of Herceptin in the summer of 1999 had anything to do with the Science Advisory Board having recently “conducted a special ‘mini-inquiry’ into the branch’s drug-review process”? Might this have been prompted by the opposition party health critic enquiring as to why the Feds were being so slow?

Maybe our mini war last summer was a tiny straw on the camel’s back.

Drug approval system under fire

Process needs overhaul to give Canadians more input, health minister told

Monday Feb 21,2000
Mark Kennedy
The Ottawa Citizen

The federal government should dramatically overhaul its drug regulatory system so that Canadians have more say in whether proposed products are approved for sale, says a report prepared for Health Minister Allan Rock.

It notes the reforms could even include a provision to require pharmaceutical companies seeking regulatory approval for their drugs to defend the products as safe and effective at public hearings. Currently, drug companies submit their applications to the federal Health Protection Branch (HPB) in confidence and their request is reviewed privately by regulators .

That process has led to controversy and a decline in public confidence over whether the approved drugs are safe. Critics have complained consumers have no say in the process. Even some of the regulators have publicly claimed that they faced surreptitious industry pressure to approve drugs without sufficient scientific review.

Now, Mr. Rock is being urged by the Science Advisory Board to shine a light on the approval process. The board, led by astronaut Roberta Bondar, is a special committee of independent experts Mr. Rock created more than two years ago to review the operations of the beleaguered health-protection branch. In the last few months, the board conducted a special “mini-inquiry” into the branch’s drug-review process.

The thrust of the board’s observations are contained in an interim report completed four months ago and obtained by the Citizen. The document concludes the “transparency” of the drug approval process is responsible for much of the “friction and controversy surrounding the work of the HPB, and the consequent decline in public confidence.”

“Unless the scientific work of the HPB can be seen to be comprehensive, rigorous, adequately funded, and free from external influences, the current low level of confidence might dip even lower.”

The board is completing its final report, which will be presented to Mr. Rock.

In addition to calling for more openness, the board will urge the government to revisit its contentious “cost-recovery” policy in which pharmaceutical companies pay user fees every time they submit a new drug for approval. Critics have alleged this policy has prompted the drug companies to assume they should get faster service from regulators, even if it means a less rigorous review of safety considerations. Drug firms deny that charge.

Still, the firms complain it often takes too long to get their products approved, and some patients awaiting new drugs already sold in other countries have similar complaints. Thus, the board has concluded Mr. Rock’s department should increase government funds for the regulatory branch, so it can clear its backlog and review drug applications more quickly.

The board examined how the U.S. approves drug applications and discovered the Food and Drug Administration adopts a much more transparent process. There, each new drug application is potentially subject to a review in public. “In Canada, in contrast, the review process is internal to HPB, with high levels of confidentiality attached to the information supplied in support of the application.”

The board notes that in Canada, while the industry has indicated it is open to making the process more transparent, it also “seeks to protect its commercial intellectual property rights.”

“No observer can fail to be struck by the fact that the same companies that insist on secrecy when it comes to their applications in Canada are perfectly prepared to send senior scientific and management representatives to public hearings in Washington … to present details of their research and to answer detailed questions on the science supporting their applications to the FDA.”

Go back to Part 1. Go back to Part 2.