Update Nov Dec 2013 - (Page 31)

Enforcement Thalidomide - Brief Overview of the Regulatory History in Canada Thalidomide was first approved for sale in Canada to treat sleeplessness and morning sickness. It was approved in Canada on November 22, 1960 under the brand name KEVADON, and again on October 11, 1961, as TALIMOL. Shortly thereafter, it was discovered that the drug caused birth defects when taken during pregnancy. Close to 12,000 babies in 46 countries were born with defects.3 In 1962, the drug was withdrawn from the Canadian market.4 Carry forward to the 1990s, the biotechnology company, Celgene Corporation (Celgene), discovered that thalidomide was useful in the treatment of multiple myeloma. Celgene began selling the drug in the United States under the brand name THALOMID. In Canada, prior to obtaining a marketing authorization, THALOMID was available in exceptional circumstances under Health Canada's Special Access Programme. The pricing of thalidomide sales made to Canadian patients under Health Canada's Special Access Programme resulted in the first-ever case involving Canada's federal pricing review board to be heard by Canada's highest Court, the Supreme Court of Canada. Following the sales made under Health Canada's Special Access Programme, Health Canada issued a marketing authorization to Celgene in 2010 for the use of THALOMID in patients with previously untreated multiple myeloma.5 However, the Minister of Health refused to designate THALOMID as an "innovative drug" on account of the prior thalidomide approvals in the 1960s. As a result, Celgene was denied data protection market exclusivity for THALOMID. FDLI This decision was appealed to the Federal Court of Appeal. Modernization of Drug Regulation in Canada The tragedy following thalidomide's early approval, and subsequent removal from the market, catalyzed significant change to new drug approval requirements in Canada. The government requested the Royal College of Physicians and Surgeons to appoint a special committee to review new drug procedures under the Food and Drugs Act.6 The intent was to critically review the Food and Drugs Act and Health Canada's regulatory powers in order for Health Canada to "more effectively carry out its purpose" and to protect the public.7 On December 20, 1962, new legislation was introduced which substantially broadened Health Canada's powers.8 For the first time, Health Canada was given the authority to enact regulations respecting: (1) the distribution or conditions of distribution of drug samples, (2) the prohibition of sale of certain drugs, (3) the methods of preparation, manufacture, preserving, packing, labelling, storing and testing of new drugs, and (4) the sale or conditions of sale of any new drug.9 In January 1963, a complete revision to the Food and Drugs Regulations10 concerning the sale and distribution of new drugs was finalized 11 and new regulations were promulgated on October 10, 1963.12 These revisions imposed strict safety requirements. For the first time, manufacturers were required to produce "substantial evidence of the clinical effectiveness of the new drug",13 including clinical case reports and in vitro studies,14 in addition to the previous safety requirements.15 Given the observations noted by the special committee, drug distribution was also an important issue to be addressed in revising the Food and Drugs Regulations. "The situation was brought into focus [...] when it was disclosed that the greatest distribution of [thalidomide] [...] was to the medical profession as free samples."16 Reports surfaced that individuals "were taking delivery of these [unsolicited] samples and selling them to wholesalers, pharmacists, and others."17 The Food and Drug Regulations were amended to discourage excessive and unsolicited sampling, through maintenance of complete distribution records by manufacturers.18 The 1960s revisions to the Food and Drugs Act and the Food and Drug Regulations regarding Health Canada's regulatory responsibilities, the new drug submission requirements as well as the distribution and sampling of prescription medicines remain substantially the same in present day legislation and Health Canada practices. Sales from the United States Subject to Federal Pricing Board in Canada Following the 1960s thalidomide tragedy, Celgene discovered that thalidomide was effective for an entirely new use: the treatment of multiple myeloma cancer. Pending regulatory review and approval by Health Canada, sales were made from U.S.-based Celgene to Canadian physicians for their patients under Health Canada's Special Access Programme. The Patented Medicine Prices Review Board The Patented Medicine Prices Review Board (PMPRB or Board) is a federal, independent quasi-judicial body created under the Canadian Patent Act.19 PMPRB has two roles in Canada. The primary function of the Board is to monitor the prices at which patented medicines are "sold in any market in Canada" to monitor for excessive prices.20 Under ss. November/December 2013 Update 31

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013