The GPha (Generic Pharmaceutical Association) in the USA has put forward a proposal to minimize key drug shortages - an ever-growing problem in the country. The GPhA says its multi-stakeholder initiative will speed the recovery of vital medications when there is a shortage, so they can more readily reach patients when they need them.
The Accelerated Recovery Initiative (ARI) involves an independent third party, manufacturers, wholesalers and distributors of generic medications (injectable ones) which are currently in short supply. The authors of the proposal refer to manufacturers, wholesalers and distributors as "stakeholders".
The Initiative is designed to give everybody concerned - GPOs (group purchasing organizations), the FDA (Food and Drug Administration), and stakeholders - a clear understanding of the supply conditions at a specific time, and to enhance the supply of vital drugs for patients in need.
Ralph G. Neas, President and CEO of GPhA, said:
"The generic industry has taken a leading role in responding to this crisis, and the ARI marks a significant step in those efforts. This type of multi-stakeholder collaboration is exactly what is required to respond to this crisis.
While this remains a complex issue that cannot be solved overnight, the ARI would significantly enhance our ability to reverse the drug shortages currently afflicting patients and prevent further ones from occurring."
The proposal of the Accelerated Recovery Initiative includes:
- The creation of a third party which would gather supply data from stakeholders for medications deemed to be vital for patients' needs.
- The gathered data would be used to determine current supply shortages and predict future ones. There would be a focus on medications that are expected to be in short supply for over 90 days.
- The FDA to create a "SWAT" team that can respond rapidly to serious shortages . The team would liaise closely with the Drug Shortage Staff expanded through the President's drug shortage initiative.
"This voluntary initiative will take place in conjunction with the excellent work currently being done by the FDA to expedite regulatory reviews and work closely with manufacturers.
It will maintain robust competition, and will not in any way deal with pricing information. It will also require prior acceptance by the Federal Trade Commission and the Department of Health and Human Services."
The data that is gathered and circulated will make communications between the FDA and stakeholders clearer and easier, resulting in faster management of potential medication shortages.
"There can be no question that generic manufacturers are in the business of supplying medicine and assuring that consumers and patients have access to the drugs they need. GPhA remains committed to working with all stakeholders to address this crisis. A lack of supply of a critical drug can be devastating, even if it impacts only one patient."
78% of all US prescriptions are of generic pharmaceuticals, which make up only 25% of all spending on prescription medications.
Written by Christian Nordqvist