The Generic Pharmaceutical Association (GPhA) has selected IMS Health, the world’s leading provider of information, services and technology for the health care industry, to serve as the Independent Third Party (ITP) in the Accelerated Recovery Initiative (ARI) the generic industry’s unprecedented multi-stakeholder initiative designed to accelerate the recovery of certain critical drugs in short supply to patients in need.
IMS will play a crucial role in assisting the US FDA with a more accurate, timely and comprehensive view of current and potential drug shortage situations, and in establishing practices to lessen or eliminate the impact of a current shortage.
“As an established industry leader with decades of experience, IMS is ideally suited to fill this critical role,” said Ralph G Neas, president and CEO of GPhA. “IMS commands the respect of all stakeholders and has a reputation for confidentiality. Their unique ability to collect, process and communicate the complex manufacturing data the ARI requires will be essential to the initiative’s success, and will strengthen the entire health care industry’s collective ability to increase communication and supply patients with the medicines they need.”
The ARI is part of GPhA’s multi-pronged effort to ensure patients have access to lifesaving generic medicines. In combination with the proposed Generic Drug User Fee Act — which will provide the FDA with $1.5 billion in additional resources and reduce the average time to review generic drug and supplement applications by nearly two years — the generic industry has stepped up to help ensure US drug safety, establish a more level playing field among all participants in the US pharmaceutical supply chain and make certain that all Americans receive timely access to safe, effective and affordable generic drugs.
Specifically, the ARI is predicated on voluntary communication between IMS and stakeholders involved in the manufacturing and distribution of critical generic medications currently in shortage. It is designed to use real-time supply and distribution information to give the FDA a better understanding of current conditions, expand the supply of critical medications, and also avert future shortages.
This voluntary initiative will take place in conjunction with the excellent work currently being done by the FDA. The type of information gathered and disseminated will increase early visibility and communication between the FDA and industry relating to current and potential drug shortages. GPhA has been working closely with the FDA, FTC, HHS and Congressional Republicans and Democrats on this initiative.
The ARI and GDUFA represent private sector leadership at its best, as well as private-public sector partnerships that will work.
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 80 per cent of the prescriptions dispensed in the US but consume just 27 per cent of the total drug spending.