Year: 2010
Resolution Number: 3
Action Taken: Referred to the Board
Status:
Author(s): Prasad Kommareddi, MD
Sponsor: John A. Waters, MD
On behalf of: Genesee County Delegation
Committee: B (Legislation)
Resolved Section(s):
RESOLVED: That MSMS adopt a policy that supports Food and Drug Administration approval of generic biologics.RATIONALE: The Committee generally agreed with the position that generic pharmaceuticals have been beneficial in terms of cost savings to patients, and similar benefits would occur if biologics were allowed to be produced generically. However, the Committee had reservations about taking this position without a more thorough review of the details of such a policy. For example, why are biologics regulated separately from pharmaceuticals currently? Furthermore, the Committee was not sure what timeline would be needed for the original manufacturer to recoup their investment in terms of research and development. For these reasons, the Committee wanted to allow the MSMS Board to appropriately study this issue in order to address these and other possible concerns.
RESOLVED: That MSMS adopt a policy that supports Food and Drug Administration approval of generic biologics.RATIONALE: The Committee generally agreed with the position that generic pharmaceuticals have been beneficial in terms of cost savings to patients, and similar benefits would occur if biologics were allowed to be produced generically. However, the Committee had reservations about taking this position without a more thorough review of the details of such a policy. For example, why are biologics regulated separately from pharmaceuticals currently? Furthermore, the Committee was not sure what timeline would be needed for the original manufacturer to recoup their investment in terms of research and development. For these reasons, the Committee wanted to allow the MSMS Board to appropriately study this issue in order to address these and other possible concerns.
Fiscal Note: NULL
Resolution: View PDF for Food and Drug Administration Approval of Generic Biologics