From: Leslie Meerburg [mailto:leslie.meerburg@hc-sc.gc.

ca] Sent: Wednesday, April 02, 2014 11:18 AM To: Zlomislic, Diana Subject: RE: Drug reviews Good morning Diana - here is the response: ******** Hello Diana, Thank you for your patience on this. Here is the list you are seeking: Could I get a list of the 128 drugs that are part of the regular monitoring activities? To clarify, 128 refers to the number of reviews and not individual products. We have assessed each of the 128 reviews to determine whether the release of the names of the products would compromise our confidentiality commitments. Some of our regular monitoring activity consists of reviewing Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) for drugs that are currently being assessed and so are not yet on the market. Given that these reports are submitted in advance of market authorization, Health Canada cannot release the names of the drugs or active substances involved. The list of marketed products that have had PSURs or RMPs reviewed in the last year can be found below. Both RMPs and PSURs are submitted to Health Canada with the understanding that this information is proprietary to the respective manufacturer and may contain information that may pose issues with confidentiality and competitive position of other drugs. Health Canada will take the steps necessary to begin publishing safety reviews of pharmaceutical drugs transparently to ensure Canadians and medical professionals have the information they need and want.

Leslie Meerburg A/Senior Media Relations Advisor | Conseillre principale p.i., relations avec les mdias Health Canada | Sant Canada (t) 613.948.8471 (e) leslie.meerburg@hc-sc.gc.ca Government of Canada | Gouvernement du Canada

From: "Zlomislic, Diana" <dzlomislic@thestar.ca> To: Leslie Meerburg <leslie.meerburg@hc-sc.gc.ca> Date: 2014-04-02 11:16 AM Subject: RE: Drug reviews

Hi Leslie, Thank you for the quick response. Unfortunately, its not in my files. Would you please try emailing it again? Cheers,

Diana

From: Leslie Meerburg [mailto:leslie.meerburg@hc-sc.gc.ca] Sent: Wednesday, April 02, 2014 11:15 AM To: Zlomislic, Diana Cc: Gary Holub Subject: Re: Drug reviews Good morning Diana, Our records indicate that Blossom sent the list to you on January 8th. Please let me know if you do not have it in your records and I will re-send. As for your other question, I am looking into it and will get back to you as soon as possible. Regards, Leslie.

Leslie Meerburg A/Senior Media Relations Advisor | Conseillre principale p.i., relations avec les mdias Health Canada | Sant Canada (t) 613.948.8471 (e) leslie.meerburg@hc-sc.gc.ca Government of Canada | Gouvernement du Canada

From: "Zlomislic, Diana" <dzlomislic@thestar.ca> To: Leslie Meerburg <leslie.meerburg@hc-sc.gc.ca>, Gary Holub <gary.holub@hc-sc.gc.ca> Date: 2014-04-02 11:04 AM Subject: Drug reviews

Hi Leslie and Gary, Im working on a story about Health Canada drug reviews. In November of 2013, your colleague Blossom promised several times that I would receive a list of 128 drugs that were part of HCs regular monitoring activities in 2013. In my last communication with her on Nov. 19 at 3:24 p.m., she wrote that the list of drugs that are part of our regular monitoring activities are being compiled as we speak. I will send this to you as soon as I can. Obviously, something has slipped through the cracks as I never received the list.

Would you please send me that list now? Im presuming it has been done and should not take any more time to compile. If HC is no longer willing to release this list, please let me know why.

My story will note that HC carries out three kinds of drug reviews. Those include: 1. Reviews of Risk Management Plans drug monitoring plans submitted by the manufacturer for their marketed products. 2. Periodic Safety Update Reports, also submitted by the manufacturer used to report and analyze the safety data related to their products after marketing 3. Drug Safety Reviews which can be triggered by reports of adverse reactions, information from a foreign regulator indicating a potential concern with a drug or through findings summarized in medical literature. My story will note that only the drug safety reviews outlined in Category 3 above is what will be released publicly starting in the next few months. If any of this is incorrect, please let me know ASAP. My deadline is 5 p.m. today.

Also, last week I asked how far back HC will go in releasing drug safety reviews. For example, will the released reviews date back six months or one year or five years? My question was not answered. If there is any confusion about what Im asking, please let me know so I can clarify. If HC does not provide an answer by end of day today, I will be forced to write that the department refused to answer the question. Thank you for your time. Sincerely, Diana Zlomislic, Health Reporter Toronto Star w: +1 416 869 4472 | c: +1 647 618 0947 dzlo@thestar.ca