Pharmaceutical controversy highlights gaps in health-care regulations

A drug manufacturer downplaying an inexpensive drug and promoting a more expensive alternative highlights gaps in the drug approval process in the United States, Canada and England.

“A drug company discouraging the use of one of its drugs is a very unique situation. It’s something that hasn’t happened before” says Queen’s University ophthalmology professor Rob Campbell.

Dr. Campbell is the lead author on the international study looking at policies and procedures in the United States, Canada and England to see how each country is handling the unique situation. The study finds that Americans are much more likely to get access to the cheaper drug than Canadians, providing valuable lessons that can be used to shape pharmaceutical policy.

Drug companies usually cover the costs of obtaining approval from regulators including the Food and Drug Administration (FDA) and Health Canada, and then apply to have their drug covered by payers such as the Ontario Drug Benefit Program. Because Genentech (now part of Roche) – the maker of both drugs involved in this report – wants neither regulatory approval nor public drug plan coverage of their cheaper drug, the Ontario public is missing out on an inexpensive drug that could save the health-care system millions of dollars a year.

The controversy involves two drugs used to treat age-related macular degeneration (AMD) – the leading cause of blindness in high-income countries.

One drug costs almost $2,000 a dose and has been approved by the FDA in the U.S. for use against AMD. The other drug is much less expensive but hasn’t been approved to fight AMD and the maker of both drugs is actively discouraging its use. A 2011 study funded by the U.S.-based National Institutes of Health found the two drugs produce similar results.

Queen’s researcher Sudeep Gill (School of Medicine) and University of Toronto’s Irfan Dhalla and Chaim Bell also contributed to the study. Dr. Campbell is also Residency Program Director and Acting Deputy Head of Ophthalmology at Kingston General Hospital and Hotel Dieu Hospital. He also works with the Institute for Clinical Evaluative Sciences.

The study is published online today by the BMJ (British Medical Journal).