NMA/CSNM, Meeting Minutes from February 27, 2009

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Contact: Director General's Office

Nuclear Medicine Alliance/Canadian Society for Nuclear Medicine (NMA/CSNM) and Biologics and Genetic Therapies Directorate (BGTD)

February 27, 2009
1:30 PM to 3:30 PM
200 Tunney’s Pasture Driveway, Room 0105, Ottawa ON

Present:

Health Canada Participants
Agnes Klein, CERB, BGTD (Chair)
Georgette Roy, CPRA, BGTD
Janice Lobo-Dale, CPRA, BGTD
Michèle Chadwick, CPRA, BGTD
Rezaul Mannan, CERB, BGTD
Rod Huggins, CERB, BGTD
Wendy Palma-Cormier, CPRA, BGTD (Secretariat)

NMA/CSNM Participants
Jean De Serres, Draximage (Chair)
Doug Abrams, Edmonton Radiopharmaceutical Centre
Sylvie Nichols, Covidien

Note: NMA/CSNM is represented by the above noted participants and includes the following organizations: Advanced Cyclotron Systems, Covidien, Draximage, Edmonton Radiopharmaceutical Center, GE Health Care, Lantheus MI, MDS Nordion, Pharmalogic, and Siemens.

Regrets:
Elwyn Griffiths, A/Director General
Alan Mortimer, CBR, BGTD
Anthony Ridgeway, CERB, BGTD
Catherine Parker, A/Associate Director General, BGTD
Lindsay Blaney, BIO, BGTD
Norman Viner, CERB, BGTD

Cyrille Villeneuve, Lantheus
Philippe Hebert, Covidien

BGTD: Biologics and Genetic Therapies Directorate
BIO: Business Integration Office, BGTD
CBR: Centre for Biologics Research, BGTD
CERB: Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, BGTD
CPRA: Centre for Policy and Regulatory Affairs, BGTD
NMA/CSNM: Nuclear Medicine Alliance/Canadian Society for Nuclear Medicine

1.0 Welcome

The Co-chairs greeted everyone and after round table introductions, the Co-chairs gave opening remarks.

A. Klein, Director for CERB, BGTD, co-chaired the meeting in the absence of E. Griffiths, acting Director General for BGTD.

J. De Serres, Draximage, NMA/CSNM informed participants that due to travel delays and flight cancellations, participants from NMA/CSNM, in particular, C. Villeneuve and P. Hebert would not attend the meeting and D. Abrams, whose flight was detained, may arrive later. Doug Abrams, in fact, arrived very shortly after.

2.0 Review of Agenda

It was noted that the agenda was lengthy.

Due to the circumstance of travel delays, and the absence of the discussion lead for two of the agenda items, the order of agenda items was changed (Item 4: E-Pedigree and Radiopharmaceuticals preceded Item 3: Status of Old Drugs Exiting the Market).

The agenda, with the change in the order of agenda items, was adopted.

3.0 Status of Old Drugs Exiting the Market

J. De Serres, Draximage, NMA/CSNM informed participants of the discontinuation of smaller radiopharmaceutical products from the market for which there is still demand, and the larger issue of those products, not meeting GMP standards that still remain on the market., remaining on the market.

J. De Serres explained that the products replacing those smaller products that have been removed from the market are being purchased from chemical companies as chemical grade, and not as pharmaceutical products.

J. De Serres shared his concern that the discontinuation of certain products from the market may be due to increased regulatory requirements.

The following comments were also expressed by J. De Serres:

• Following meeting discussions with HPFB Inspectorate, it was understood by NMA/CSNM that HPFB Inspectorate has taken a very strong position whereby the requirements imposed on smaller radiopharmaceutical products will not be negotiated.
• NMA/CSNM would like continue discussions with BGTD and HPFB Inspectorate to identify alternative mechanisms for consideration for ways in which requirements for smaller radiopharmaceutical products are inclusive to the public need and the global picture for the continued availability of smaller products.
• The general public is significantly impacted with increased regulatory requirements and no alternative mechanisms for compliance as the manufacturing costs increase with longer manufacturing processes.

J. De Serres took the opportunity to also talk about the upcoming face-to-face meeting of the WG on Regulatory Toolkit for Medical Isotopes scheduled for March 27^th for discussion on medical isotope supply issues. With respect to this upcoming meeting, J. De Serres would like to include discussion with respect to the level of associated risk, both legal and regulatory levels of risk.

Action Item:
J. De Serres, Draximage, NMA/CSNM to provide G. Roy, BGTD with a list of issues that NMA/CSNM would like to discuss further and possibly address at the March 27^th meeting. Some issues include the level of use of the radiopharmaceutical product in Canada and the level of use of the radiopharmaceutical products worldwide, and clarity surrounding specific Good Manufacturing Practice (GMP) matters.

4.0 E-Pedigree and Radiopharmaceuticals

J. De Serres, Draximage, NMA/CSNM informed participants of the debate taking place in the U.S. surrounding the requirements for electronic tracking/barcoding of drug products.
The e-pedigree initiative aims to decrease counterfeiting in the marketplace and aid in tracking the importation of drug products. States across the U.S. are divided on whether or not to implement this initiative. California is leading the debate to require increased barcoding on drug products by 2013. At the moment, radiopharmaceutical products are not included on the list of drug products that will require the increased level of barcoding. Other countries, for example, France and Turkey have also discussed the use of barcoding on all drug products. France will begin implementing the requirement for barcoding in January 2011, while Turkey has already begun.

NMA/CSNM is interested in Canada’s position on the use of barcoding as it specifically relates to radiopharmaceutical products.

G. Roy, BGTD informed participants that radiopharmaceutical products currently are not issued DINs and is not aware of any requirement, by Health Canada, for barcoding of radiopharmaceutical products.

J. De Serres made the comment that generators and the issue surrounding scheduling of tests with TC-99m is an increasingly difficult issue.

G. Roy, BGTD agreed to a teleconference with C. Villeneuve, for Health Canada and Lantheus to discuss the generator issue.

Action Item:
C. Villeneuve, Lantheus, NMA/CSNM to coordinate date/timing for a meeting to discuss issues surrounding Canadian generators.

5.0 Radiopharmaceutical (Isotope) Supply

A. Klein, BGTD informed all participants that issues surrounding radiopharmaceutical supply would be discussed at the upcoming face-to-face meeting of the WG on Regulatory Toolkit for Medical Isotopes scheduled for March 27^th.

D Abrams, Edmonton Radiopharmaceutical Centre and J. De Serres, Draximage NMA/CSNM briefly discussed relevant alternative advantages/disadvantages that could be discussed and further explored at the March 27^th meeting. These included the following:

• The need to explore other imaging modalities for diagnostic testing due to the lack of Technetium (Tc-99m-) and the increased burden on traditional imaging such as MRI or CT;
• The possibility for the substitution of Technetium (Tc-99m- with Thalium-201. Although not all nuclear medicine departments use Thalium-201, it can be provided upon request;
• Implications beyond the isotope supply issue include the costs associated with the development process and viability of radionuclide (gallium) generators. Of note, the gallium generator is not developed in Canada; and
• The efficient use of generators: practical use versus ideal situation and likewise, current scheduling practices versus the most effective use of running the generator for several days at a time.

6.0 Proposed Licensing Fees for Schedule 3 Drugs/Future Direction for Post-market Radiopharmaceuticals

G. Roy, BGTD informed participants of the decision to delay the requirement for DINs for radiopharmaceutical products under the Food and Drugs Regulations. The issue surrounding the requirement of DINs for radiopharmaceutical products will be added to the Progressive Licensing Framework. Subsequent to this decision, the respective fee structure for radiopharmaceuticals will be discussed in the second round of the cost recovery initiative. In addition, it was noted that, at this time, the provision for a fee reduction may also allow for a provision for the waiver of fees and when/if sales volume is relatively low (below a defined gross revenue), a fee reduction is acceptable and highly possible. Regardless of the reduction/waiver of fees, the review times will remain as specified: 300 days for non-priority submissions and 180 days for priority submissions.

J. De Serres, Draximage, NMA/CSNM noted that an increase in the structure of fees for reviews will limit the number of products and the availability of those products to Canadians. NDS fees can be high considering the requirements for clinical, chemistry and manufacturing data. In addition, to the cost for clinical trial research, the cost recovery framework includes for multiple indications, and according to the proposal by the Inspectorate in July 2007, each site will have a fee attached for the GCP inspections, under the new cost recovery framework.

Action Item:
M. Chadwick, BGTD to inquire about the status of the discussions had at the July 3^rd 2007 cost recovery WG meeting to include fees for GCP inspections and provide an update to participants.

7.0 New GMP Guidelines for Radiopharmaceuticals/
Novel Radiopharmaceuticals in Clinical Trials

J. De Serres, Draximage, NMA/CSNM expressed concern for the lack of clarity and understanding from the users point of view surrounding clinical trials, GMPs and research. In particular, J. De Serres and D. Abrams requested more information in regards to what constitutes a clinical trial; what it means to the user and to the regulator to have GMPs; and how research is defined and what it should entail.

It was also mentioned that in contrast to pharmaceutical products, radiopharmaceutical/ nuclear medicine products have not had a source of reliable, researched clinical data and that the information available is ten years or less. Until recently, there has been a lack of evidence-based data resulting in a discomfort with what data is available to physicians.

A. Klein and G. Roy, BGTD stated that the regulatory approach taken by BGTD for reviews is comparable to approaches taken by international regulators. BGTD maintains rigour through broad analysis to ensure that all approaches are taken into consideration.

Action Item:
J. De Serres, Draximage, NMA/CSNM to draft a letter for the purpose of listing the radiopharmaceutical/nuclear medicine products used/authorized for sale in Canada; and for the purpose of collecting information on GMP-related matters of interest and associated risks managed. The letter will also request information on the applied regulatory elements.

8.0 Summary Basis of Decision

G. Roy, BGTD informed participants that the Summary Basis of Decision (SBD) update has been added to all agendas for meetings with associations.

The evaluation of phase I of the joint BGTD-TPD Summary Basis of Decision (SBD) project has begun. A questionnaire was sent to all sponsors who have had an SBD prepared to request their input into the process thus far. The next step includes the Health Canada website posting of the evaluation workbook, which is scheduled for the summer of 2009. The style of the evaluation workbook will be similar to that for the Blueprint for Renewal. Stakeholders will be invited to complete the evaluation. Stakeholders are encouraged to complete the questionnaire, if not already done so, which was sent, in December 2008, to all drug submission sponsors and medical device manufacturers Following the evaluation, development of phase II of the SBD project will begin. Phase II will involve the analysis of comments received from the phase I project.

G. Roy advised participants of the delay in webpostings due to updates to the HC website with respect to the Common Look and Feel (CLF) 2.0 project. At present, there is a 3-month delay for postings. SBDs are at a priority level 3 for postings.

Since January 2005, the number of BGTD products which had an SBD prepared is as follows: biologics - 22; and radiopharmaceuticals – 4.

Of note, Product Monographs for market notified products have been posted on the Health Canada web site since January 2008.

9.0 Roundtable

Appreciation for having this meeting was shared by all NMA/CSNM participants.

J. De Serres, Draximage, NMA/CSNM provided a brief update on the status of the association in response to concerns about the future existence of this group. A proposal has been put forward, in which NMA/CSNM is considering administrative support from the association MEDEC.

D. Abrams, Edmonton Radiopharmaceutical Centre, NMA/CSNM requested that BGTD and NMA/CSNM meet twice annually.

Overall appreciation of timely concerns and focused discussions around the agenda item summaries (AISs) provided was shared by all.

The meeting was adjourned at 2:29 PM.