Are gaps in the time of submissions and approvals of new drugs between health Canada and the food and drug administration related to therapeutic value? A cross-sectional study.

BACKGROUND: Health Canada is proposing to use decisions by foreign regulators in approving new drugs to speed up their marketing. OBJECTIVES: To investigate the length of gaps in submissions to and approvals by Health Canada compared to the Food and Drug Administration (FDA) for the same drugs for the same indications. To determine if the gaps are hindering the availability of drugs with significant additional therapeutic value. METHODS: A list of new drugs approved by Health Canada from January 1, 2011 onwards and the FDA for the same indications was constructed. The median length of gaps in submissions and approvals was calculated. The distribution of therapeutic value - major, moderate, minor - was compared for all drugs and antineoplastic agents depending on the length of the gap (0-1, 1-2, 2-3, 3+ years). The number of FDA approved drugs not available in Canada was counted along with their therapeutic value. RESULTS: Health Canada and the FDA approved 502 drugs for the same indication. The length of the gap in submissions and approvals did not increase over the period (p = 0.5972 and p = 0.0875, respectively). The distribution of therapeutic value for all drugs and antineoplastic agents was the same regardless of the length of the gap (p = 0.7091 and p = 0.3395, respectively). Out of 542 FDA approved drugs 134 were not marketed in Canada. CONCLUSION: It is unclear whether gaps in submissions and approvals are preventing therapeutically important new drugs from reaching Canadian patients in a timely manner.