Judicial review of a decision by Health Canada under the Food and Drugs Act; 2009 FC 244; vancomycin; April 7, 2009
The Court upheld the decision of Health Canada that the applicant's product was indeed a "drug in dosage form" and thus was subject to the provisions of the Food and Drugs Act and Regulations. The Court further held that there was no denial of procedural fairness in the process.
The applicant, CPTI, makes vancomycin hydrochloride in a powder form which it sells in fixed, premeasured, standardized package units to pharmacies and hospitals in Canada. It is not sold directly to consumers but rather was alleged to be an active pharmaceutical ingredient intended for use by licensed pharmacists in compounding.
CPTI had previously succeeded in an application that Health Canada had breached the duty of fairness it was owed in a classification proceeding, by not providing it with the opportunity to respond with evidence to a position taken by Health Canada regarding this product. As a result of that decision, Health Canada needed to provide CPTI with an opportunity to respond.
CPTI took the position in starting this application that Health Canada still had not met the requirements of procedural fairness in the steps it had taken after the finding in the previous application.
The Court found that procedural fairness was not violated and that there was no discrimination against CPTI on the basis that other companies in Canada are selling vancomycin products to pharmacists without being required to obtain a DIN.
The Court then considered the merits of the hearing finding that the statutory definition of drug is very broad and that vancomycin fits within that definition.
A drug in dosage form is defined as being a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing. CPTI argued that the further steps taken by pharmacists before its product is patients amounts to further manufacturing or transformation of the product. Health Canada identified the degree of control exercised by manufacturers versus pharmacists over the dosage of the drug that was ultimately administered to the patient as key to his analysis as to whether this was drug and dosage form.
In this case, as the product contains a premeasured amount of drug substance that corresponds to a standard dosage of vancomycin hydrochloride normally administered to the patient, it is CPTI's actions that determine the amount of drug substance received by the patient. The intervening actions of the pharmacists in adding excipients or diluents do not change the fact that the total delivered dosage of the product was determined by the manufacturer.
As Health Canada should be afforded considerable deference due to the considerable fact finding and level of similarity which the Court does not share, the conclusion drawn was reasonably open to Health Canada. Thus, the application for judicial review was dismissed.
The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2009/2009fc244/2009fc244.html