INTERNATIONAL REGULATORY COMPLIANCE by smx43008

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                                                                                               October 23, 2009


INTERNATIONAL REGULATORY COMPLIANCE

The FDA continues to follow up on manufacturing companies domestically and abroad issuing "warning
letters" to those who have not completely resolved concerns raised during inspections. The issuance of
warning letters typically attracts attention from other regulatory agencies.

CANADA-PROVINCIAL GOVERNMENTS

Market Access news on Amlodipine (the biggest genericization ever in Canada)
Norvasc® is the biggest brand to have been genericized in Canada. Pfizer has launched its own generic
Amlodipine under the "Gen-Med" label. It has sought listing in public formularies as a generic and at generic
pricing. Pfizer was the only participant and won a tender process in Saskatchewan. Mylan and other
generics are listed in 8 of 10 provinces (including the big four: Ontario/Quebec/BC/Alberta). The
extraordinarily long time taken to list a new generic by provinces who are looking for savings is well
illustrated by our experience with Amlodipine. Two provinces have yet to list the generic products costing
them thousands of dollars per day.

Alberta
Reductions in generic pricing and reimbursement for pharmacy services are the key issues for government
and increasingly, third party payers. Alberta is leading the charge to achieve price equalization with Ontario
on existing generic products and to set requirements for lower prices on future generic products. Phase 2 of
Alberta’s Pharmaceutical strategy was introduced on October 20, 2009. The stated objectives are reduce
generic drug prices, provide faster access to new drugs, reduce costs and expand the role of pharmacists to
better meet needs of patients.

1.Generic drug prices:

Prices for new generic dugs will be set at 45 percent of the brand as listed in the Alberta Health & Wellness
Drug Benefit list (AHWDBL) immediately (affects new market entries like Rivastigmine). Prices will be
approximately 48% of brand compared to other provinces. Savings of $100 million are expected from
Alberta Health’s programs (excludes significant savings to be made by Alberta’s employers plans).
Prices for existing generic drugs will also be similarly reduced, beginning in April 2010 based on a formula to
be published in December 2009. The reduction will be part of discussions with pharmacy over the next 6
weeks. There is the potential for exceptions to be made from this rule. The intent is “one price” for a generic
product in Alberta regardless of payer (not so for brand products subject to product listing agreements).
There is no interference with commercial terms between Generic companies and Pharmacy. There will be
monthly additions to the AHWDBL in 2010.

2. Brand products:

Alberta will negotiate contracts known as product listing agreements with brand name drug manufacturers.
 




                                                                                                                      



    3. Pharmacy:

    The government will work with Pharmacy to define and introduce a new compensation model by July 1,
    2010.

    Recognition for the need for transition plan has been made with the provision of a fund of $5million to enable
    rural and remote pharmacies to adapt to the new model (eligibility will be based on a points system);through
    temporary incremental allowances per prescription dispensed (where the cost is less than $75), which
    decline, over the next 3 years and; through a Memorandum of Understanding in which there is agreement to
    define a transition structure and plan for the compensation model by December 1,2009.

    Ontario
    The Ministers of Health in Ontario and Newfoundland resigned this month. The new Minister in Ontario is
    Deb Mathews. The installation of a new Minister in Ontario will not disrupt Ontario's timeline for change
    needed by April 1, 2010.

    BC
    In British Columbia Pharmacare and Pharmacy have started to discuss life beyond the "interim" agreement
    which they signed at the end of 2008. A huge effort is being invested in the training of pharmacists to enable
    them to administer the seasonal flu and H1N1 vaccines.

    Quebec
    There is a new director at the head of the Conseil du medicament, Carole Marcotte.


    Recent Product Launches from Mylan

    Mylan-Omeprazole, 10mg, 20mg
    Mylan-Amlodipine, 5mg, 10mg
    Mylan-Levofloxacin, 250mg, 500mg
    Mylan-Leflunomide, 10mg, 20mg
    Mylan-Tamsulosin, 0.4mg
    Mylan-Nifedipine Extended Release, 60mg

								
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