Children are too often neglected when pharmaceutical companies bring new drugs to market and apply for approval in Canada, says an editorial published in the Canadian Medical Association Journal.
As a result, the Compendium of Pharmaceuticals and Specialties, which is the principal reference guide to prescribing information for Canadian doctors, often lacks safety, efficacy and kids’ dosing information for drugs that children might benefit from taking, argues one of the authors, Bob Peterson, a Vancouver pediatrician.
And yet, regulatory authorities in the United States or Europe might already have this information, the authors write.
“I do not like to have statements that are not accurate in the Canadian product monograph, and to say that there is insufficient information to support the use of the drug is probably an inaccurate statement if that drug has been approved by the FDA [U.S. Food and Drug Administration]” said Dr. Peterson, who was director general of Health Canada’s Therapeutic Products Directorate for several years until 2005.
He said Health Canada needs to step in and regulate.
“I’m not big on big government regulating where it doesn’t have to, but in this case we’ve clearly seen an example whereby a voluntary behaviour of an appropriate nature that is consistent with what is done in other countries is not happening, it has not happened and that’s exactly the scenario where government should step in and regulate.”
According to the editorial, the U.S. Congress passed legislation in 2003 requiring companies with drugs expected to be used in children to conduct studies and submit results to the FDA. As well, there was a financial incentive of an extra six months of market exclusivity. In Europe, an amendment in 2006 provided an extra six months of data protection, effectively slowing down generic versions of a drug from coming to market.
As of March, Dr. Peterson said, the FDA had given 181 drugs this market exclusivity in the United States, and their pediatric labels were in place.
Paul Hebert, editor-in-chief of the medical journal, said Health Canada also tried the incentive route, providing a six-month extension for data protection similar to the European one. He said drug companies should answer why they’re not always submitting to Canadian regulatory authorities the research that exists on pediatric use of certain drugs – even though some of that research might have been conducted on Canadian kids.
Reacting to the editorial, Canada’s Research-Based Pharmaceutical Companies, or Rx&D, issued a statement that said about 25 new drug submissions have been granted pediatric extensions by Health Canada.
“Increasingly, companies are presenting pediatric development plans to Health Canada with their new drug submissions,” said the statement from Christine Choury, director of media relations. “For some disease areas such as infections, allergies and asthma, development programs for drugs and vaccines are done in the pediatric population first, or concurrently in the adult population.”
The CMAJ editorial, signed by Dr. Hebert, Dr. Peterson and four other doctors, cites the case of Celebrex, a medication approved in 2006 in the U.S. to treat juvenile idiopathic arthritis, and said the CPS states that there is insufficient evidence to support its use for this condition.
Dr. Hebert said pediatricians working in an academic environment or a children’s hospital, for instance, would know about this, and would have access to the U.S. prescribing information because “that’s all you do for a living.”
“[However] imagine if you’re in Wawa or Peterborough and you’re a busy family doctor and you’re prescribing to children all the time. You have to look up dosages, and all you get is ‘not safe in children,’ ” Dr. Hebert said.
“The CPS is a very, very important tool for practising doctors – it’s the first place you look because it’s easy and it’s reliable, so that’s the first thing. It’s the one we use – it ought to be in there.”
Dr. Peterson said applications to Health Canada are filed in confidence, under a cloak of secrecy, and it’s possible that some drug companies have provided information to the agency and been told there’s not enough data.
“I don’t have any knowledge about that … but having been at Health Canada, I wouldn’t be surprised to hear that. But it’s not in all of these instances, and I don’t believe that it is in the case that we cited.”
The Rx&D statement said that given the complexity of pediatric studies, the industry supports efforts to harmonize regulations with the U.S., the European Union and developed countries so that regulatory authorities can share information and best practices while at the same time maintaining Canadian standards.
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