Record of Decisions - June 27, 2011, Canadian Generic Pharmaceutical Association (CGPA)

Contact: Office of Business Transformation

Health Canada - Health Products and Food Branch - Bilateral Meeting Program

Record of Decisions: Canadian Generic Pharmaceutical Association (CGPA)

Location: 1600 Scott Street, Holland Cross, Tower B, 2^nd Floor, Boardroom 2048, Ottawa, Ontario

Date: Monday, June 27, 2011

Start Time: 1:30 p.m.

End Time: 4:00 p.m.

Participants

CGPA Participants

Len Arsenault, Sandoz, Co-Chair
Bruce Clark, Apotex
Dawn Culp, Mylan
Gaetano Gallo, Pharmascience
Lul Ogba-Ghebriel, Taro
Sukhvir Hundal, Ranbaxy
Kent Major, Ratiopharm
Joanne Soltesz, Sandoz
Julie Tam, CGPA
Scott Tomsky, Ranbaxy

Health Canada Participants

Supriya Sharma, Director General, Therapeutic Products Directorate ( TPD), Co-Chair
Hieu Vu, Acting Senior Executive Director, TPD
Andrew Adams, Bureau of Pharmaceutical Sciences ( BPS), TPD
Anne Bowes, Office of Patented Medicines and Liaison ( OPML), TPD
Pauline Gaudry, Submission and Information Policy Division ( SIPD), TPD
Gail Gervais, Liaison Unit, Office of Business Transformation ( OBT), TPD
Katie Greenwood, BPS, TPD
Alice Hui, OBT, TPD
Waleed Jubran, OPML, TPD
Lisa Lange, Bureau of Policy, Science and International Programs ( BPSIP), TPD
Alain Musende, Marketed Health Products Directorate ( MHPD)
Denise Quesnel, Liaison Unit, OBT, TPD

Observers

Paul Litowitz, Director General's Office ( DGO), TPD
Satish Mallya, BPS, TPD
Stéphanie Parra, BPS, TPD
Joyce Pon, BPSIP, TPD

Regrets

Brian DesIslet, Novopharm
John Hems, Apotex
Andy Hua, OBT, TPD, Health Canada

1. Welcome and Introductions

Dr. Supriya Sharma, Director General, Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB), welcomed everyone, and a roundtable of introductions followed.

1. Organizational Update
   
   Dr. Supriya Sharma provided the following staffing updates at the Directorate and at the Branch levels:
   
   Paul Glover has joined the HPFB, as the new Assistant Deputy Minister (ADM), on February 7, 2011. Scott Sawler is the new Director General for the Natural Health Products Directorate.
   
   Kimby Barton is the Director of the Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD. Megan Bettle is the Associate Director for BCANS.
   
   Katie Greenwood is the Associate Director of the Bureau of Pharmaceutical Sciences (BPS), TPD.
   
2. Canadian Generic Pharmaceutical Association (CGPA) Update
   
   Len Arsenault, CGPA, informed attendees that John Hems sends his regrets, as he was not able to attend the meeting. Last week, CGPA met with Glenda Yeates, Deputy Minister and Paul Glover, Assistant Deputy Minister. It was an excellent meeting, with good dialogue.
   
3. Cost Recovery (CR)
   
   Dr. Sharma provided the update on CR. The new regulations entitled Fees in Respect of Drugs and Medical Devices Regulations came into effect on April 1, 2011. They will provide sustainable funding allowing for critical positions to be filled. The regulations update existing fees related to human drugs and medical devices, but do not apply to food, natural health products, veterinary drugs or any other area that is not cost recovered.

2. Review of Agenda

The agenda was accepted as presented.

3. Approval of the Record of Decisions of June 28, 2010

The Record of Decisions was approved as presented.

Follow-up from the Previous Meeting:
Prioritizing the Review of Generic Drug Submissions (Item 7)
TPD is studying a proposal to use the link between the Patent Medicines (Notice of Compliance) Regulations and the drug review process to prioritize the review of generic drug submissions. Joanne Soltesz, CGPA, will present the proposal to CGPA members, to the patent committee and to the regulatory group.

Action: CGPA to provide feedback and suggestions on how best to prioritize the review of submissions.

Update: Julie Tam, CGPA, provided the information during a CGPA and Bureau of Pharmaceutical Sciences (BPS) meeting which was not part of the regular HPFB Bilateral Meeting Program (BMP). Julie Tam mentioned that companies have their own strategy on when to submit to Health Canada. Dr. Sharma informed the group that it is a matter of resources; need to prioritize on patent expiry. Kent Major, CGPA, mentioned that CGPA is willing to sit with Directors to come to a solution. Dr. Sharma stated that this was not a priority for TPD at this time.

Action item completed.

4. Process Improvement Initiative/Reporting on Progress

CGPA met with Glenda Yeates, Deputy Minister and Paul Glover, Assistant Deputy Minister to secure an agreement to undertake a fundamental overhaul of the Abbreviated New Drug Submissions (ANDS), Supplemental Abbreviated New Submissions (SANDS), and the Notifiable Changes (NC) reviews that is resourced and able to meet established performance targets. There is commitment from Mr. Glover to work with CGPA on a process improvement initiative with short-term and long-term achievements. The revised cost recovery initiative will provide funding to support the generic drug review process, but CGPA believes that money alone will not solve the problems nor will piecemeal changes that have the effect of fixing one problem, but cause another.

The successful completion of this initiative will provide many benefits. It will resolve the backlog and create an environment that Health Canada employees can be proud to work within because achievements can be attained, and foster improved industry-government synergies.

CGPA would like to develop and finalize an action plan collaboratively with TPD. Health Canada would identify the goals, actions, responsibilities and timelines necessary regarding ANDS, SANDS and NC review performance.

Andrew Adams, Director, BPS, TPD, informed CGPA that the TPD is working to reduce the backlog of ANDS/SANDS submissions and has set a target to reduce the backlog to 25% of workload by the end of March 2012, and to 0% by March 2013. The three elements of the backlog reduction strategy are the Human Resources, Process Improvement and Industry's Responsibility.

Human Resources
For Human Resources, BPS is working to hire chemists and is aiming to bring in 25 new resources in the fall of 2011. Staffing will include indeterminant staff, terms and contractors. While good candidates have been identified in Toronto and Montreal, it has been difficult to attract them to Ottawa, since they do not want to relocate. Andrew Adams asked what CGPA/Industry is prepared to do to help train new staff. Training by industry, and other experts would be helpful. Facility visits, allowing Health Canada staff to spend several weeks in a facility to see all aspects of manufacturing (from receipt of ingredients to shipping of finished product) would also be of interest. It was also mentioned that short term site visits would be beneficial, but it could be for extended time period or short time periods. Manufacturers could be asked to volunteer to host two or three Health Canada employees at a time, as it would be important for staff to see a manufacturer's environment. Considering the cost of travelling, training in Canada would be preferred to training in United States sites.

Action: Len Arsenault and Julie Tam, CGPA, will outline a framework and they will contact Andrew Adams, BPS, TPD, to discuss the framework once it is completed.

Process Improvement
BPS initiated a process-mapping, process improvement exercise towards the end of 2010-2011. This will continue in 2011-2012 and will include:

• Risk Based Review
  For the Risk Based Approach, CGPA would like to have a working group, with TPD and CGPA employees. Kent Major, CGPA, mentioned that he would like to sit with TPD between now and September 2011 to discuss next steps, screening and value mapping.
• Pre-Evaluation
  Pre-evaluation needs to be reviewed to ensure that it is providing value commensurate with the resources required. TPD is seeing deficiencies in submissions therefore in order to help improve the quality of submissions, TPD would be happy to provide CGPA with more information.
• CGPA/Industry input
  Unique Canadian requirements.
  Action: Len Arsenault, CGPA, has committed to send a list to BPS, TPD, in two weeks.

Industry's Responsibilities
Industry can contribute to TPD's success in reducing the ANDS/SANDS backlog by:

• Appropriate use of the Canadian Quality Overall Summary -Chemical Entities (QOS-CE)
  Use as a summary.
  TPD wishes to see good quality submissions coming in, and would like companies to commit to this request.
• Submission of well formatted electronic Common Technical Document (e-CTDs) (Biopharmaceutics)
• Increased Use of Certificate of Suitability of Monographs of the European Pharmacopoeia (CEPs)
  Stéphanie Parra, Manager, BPS, Generic Drugs Quality Division, is the lead for CEPs. She informed CGPA that reviewers like to see that a CEP has been filed as it facilitates the review of the drug substance part of a submission. The requirements are still as described in the March 2007 TPD notice on use of CEPs. Sponsors and Drug Master File (DMF) owners need to be aware of the process and the type of drug substances it can be used for. TPD/BPS may send comments if the criteria described therein are not met [for example (e.g.) the CEP is not valid]. For TPD, CEPs are a time saver, but are not used often enough.
  
  Some companies expressed concern that a DMF still had to be filed and some Active Pharmaceutical Ingredients (API) manufacturers do not wish to have to file a DMF in Canada. Dr. Parra responded that in order to obtain a CEP, an Active Substance Master File (ASMF) (Type I DMF) has to be filed with the CEP application. Therefore, the file already exists and the cost for filing a DMF in Canada remains low.
• Timely complete responses to clarifaxes, Notices of Noncompliance (NONs), Notices of Deficiency (NODs)

5. Notifiable Changes (NC) Proposal

CGPA needs TPD's commitment to resolve the NC review issue in the short-term, and in a way that is acceptable to all stakeholders and is not sector-biased. The proposed NC initiative will shift 58% of generic NCs into the SANDS category with no assurance that performance in the SANDS category will be achieved. The proposed NC initiative will trigger additional litigation as a result of the Product Monograph (PM), and Notice of Compliance (NOC) Regulations. CGPA believes that this initiative will result in less business certainty and additional costs to the industry. The proposed initiative will not resolve the regulatory issues that the generic industry has identified as contributing to some drug shortages. CGPA needs to collaboratively work with TPD on this proposal.

Another concern is the change in linkage requirements and interpretation of change. Industry has problems with supply chain and Access to Information (ATI) supplies. It is important for Industry to look at the issue as broad as possible. Kent Major would like Health Canada, TPD, to move faster than 5 years. Anne Bowes discussed the need to look at the details, of the Intellectual Property (IP) side of issues. Discussion of a brain storming session was brought up. CGPA would like to know which Supplemental New Drug Submission (SNDS) would trigger a change. CGPA would then be able to inform its manufacturers and lawyers.

Next steps, CGPA would like to understand the process on linkages. A meeting between CGPA and Anne Bowes would be beneficial before requesting a meeting with the Assistant Deputy Minister of Health Canada.

6. Direct-to-Consumer Advertising (DTCA) of Prescription Drugs on Websites of Generic Market Authorization Holders (MAH)

Alain Musende, Head, Regulatory Advertising Unit, Marketed Health Products Directorate (MHPD), provided an update of the situation, including recent discussions which occurred between Health Canada and various MAHs of generic drugs. CGPA will be in a better position to understand Health Canada's concerns and to remind its members about the federal health product advertising regulatory framework.

Market Authorization Holders (MAHs) of generic drugs provide information on their corporate websites with respect to their prescription drugs (through access to product catalogues). Health Canada has assessed a number of these websites accessible to the general public and concluded that the information provided was exceeding the restrictions set out in Section C.01.044 of the Food and Drug Regulations. Several MAHs have been requested to bring their websites into compliance with the Food and Drug Regulations.

Health Canada has recently contacted several market authorization holders of generic drugs in Canada with respect to their websites and concerns related to direct-to-consumer advertising of prescription drugs. Corporate websites would generally fall within the definition of an institutional message: A communication (e.g., brochure, published article, prospectus, annual report, etc.) which provides information about a pharmaceutical manufacturer or other institution concerning its philosophy, activities, product range (by name), financial details, area of future development or research, etc.

Such messages may be considered non-promotional when they meet the following criteria outlined in the policy "The Distinction Between Advertising and Other Activities":

• The purpose of the communication is clearly to provide information about the institution rather than about the drugs being marketed, developed or researched;
• Information about the drugs being marketed, developed or researched is limited to the name and therapeutic use of the drug; and
• No emphasis is given to any one or more products, or their benefits.

Since most websites were providing additional product information that has been selected by the manufacturer (e.g., routes of administration, dosage forms, shapes, colours, therapeutic classes, active ingredients, pictures of pills or boxes, Drug Identification Numbers (DINs), formulary status, and brand references) the websites have been considered promotional.

Where the products were prescription drugs (Schedule F), it was deemed to exceed the restrictions set out in Section C.01.044 of the Food and Drug Regulations which reads as follows:

After having sent regulatory letters and discussed the issues with some MAHs through teleconferences where further clarifications were provided, three major companies made modifications to their websites. Meaningful access restrictions to restrict consumer access to any product-focussed promotion of prescription drugs have been implemented. The gating systems that have been put in place require that healthcare professionals provide their licence number or code to access the promotion of prescription drugs. Measures where anyone could self-identify as a healthcare professional and be provided with the full access to the website have been deemed unsatisfactory. Other MAHs will be expected to made similar changes once contacted.

Health Canada does not object to the practice of posting Health Canada's authorized Product Monographs or Consumer/Patient Information Leaflets on corporate websites listing products manufactured by MAHs. When done within a non-promotional context (example: not accompanied by, or associated to, any promotional material), this has been considered acceptable and not subject to the advertising provisions of the Food and Drugs Act and Regulations, since the Product Monograph is a factual, scientific document which is devoid of promotional material.

Health Canada strongly encourages the use of the independent Canadian advertising preclearance system - a voluntary but valuable resource to help advertisers develop promotional material which complies with the regulatory provisions of the Food and Drugs Act and Regulations. The List of Canadian Advertising Preclearance Agencies can be found on the Health Canada website. MAHs are encouraged to submit their websites to either Advertising Standards Canada or the Pharmaceutical Advertising Advisory Board for preclearance.

7. Round Table

1. CGPA priorities
   Performance is a big issue. CGPA would like to work on Identical Medicinal Ingredients (IMI) issues soon. TPD had identified it as an issue before, but cannot devote resources to it at this time.
2. Product Monographs
   Alice Hui, Office of Business Transformation (OBT), TPD reminded CGPA to contact TPD to monitor and update the Product Monographs.
3. Drug Master File (DMF)
   Pauline Gaudry, Submission and Information Policy Division (SIPD), TPD, informed CGPA that the fees will go up again, but does not know when.

8. Adjournment

Meeting adjourned at 4:00 p.m.

9. Next Meeting

Wednesday, November 23, 2011, at 1:30 p.m.

Original signed by

Dr. Supriya Sharma
Director General
Therapeutic Products Directorate