Year: 2013
Resolution Number: 35
Action Taken: Approved
Status:
Author(s): James Szocik, MD
Sponsor: James Szocik, MD
On behalf of: Washtenaw County Delegation
Committee: B (Legislation)
Resolved Section(s):
RESOLVED: That our AMA educate its members and the public as to the economic and health aspects of drug shortages via material on the web; and be it furtherRESOLVED: That MSMS and the AMA work to draft example economic contractual solutions to the drug shortages; such as “failure to supply “clauses that are legally enforceable with the aim of decreasing drug shortages by increasing supply, either by encouraging Group Purchasing Organizations to buy more than is needed and stockpile excess drug (and take the financial risk) or encouraging the manufacturer to develop excess capacity to meet sudden unanticipated shortages (and take the financial risk); and be it furtherRESOLVED: That our AMA work with the Food and Drug Administration in its continued efforts to decrease drug shortages by tracking the impact of any “failure to supply” clauses on drug costs, drug supply, and drug shortages; and be it furtherRESOLVED: That, in the event that legal and contractual solutions fail as evidenced by continued or worsening drug shortages as tracked by the Food and Drug Administration (FDA), that MSMS and the AMA work with legislators to propose laws addressing the economics of the drug shortage that may act as restraints on trade well outside the jurisdiction of the FDA, such as mandating multiple supply chains, stockpiling of drugs, or other means to decrease shortages; and be it furtherRESOLVED: That our AMA advocate that any legislation that addresses the economics of the drug shortage, such as mandating multiple supply chains, stockpiling of drugs, or other means to decrease shortages include both a sunset provision and a monitoring period to assure their effectiveness.
RESOLVED: That our AMA educate its members and the public as to the economic and health aspects of drug shortages via material on the web; and be it furtherRESOLVED: That MSMS and the AMA work to draft example economic contractual solutions to the drug shortages; such as “failure to supply “clauses that are legally enforceable with the aim of decreasing drug shortages by increasing supply, either by encouraging Group Purchasing Organizations to buy more than is needed and stockpile excess drug (and take the financial risk) or encouraging the manufacturer to develop excess capacity to meet sudden unanticipated shortages (and take the financial risk); and be it furtherRESOLVED: That our AMA work with the Food and Drug Administration in its continued efforts to decrease drug shortages by tracking the impact of any “failure to supply” clauses on drug costs, drug supply, and drug shortages; and be it furtherRESOLVED: That, in the event that legal and contractual solutions fail as evidenced by continued or worsening drug shortages as tracked by the Food and Drug Administration (FDA), that MSMS and the AMA work with legislators to propose laws addressing the economics of the drug shortage that may act as restraints on trade well outside the jurisdiction of the FDA, such as mandating multiple supply chains, stockpiling of drugs, or other means to decrease shortages; and be it furtherRESOLVED: That our AMA advocate that any legislation that addresses the economics of the drug shortage, such as mandating multiple supply chains, stockpiling of drugs, or other means to decrease shortages include both a sunset provision and a monitoring period to assure their effectiveness.
Fiscal Note: NULL
Resolution: View PDF for Addressing Drug Shortages