Tuesday, February 21, 2012
The Generic Pharmaceutical Association (GPhA) today underscored its dedication to working with all stakeholders to eliminate existing shortages of critical drugs and minimize the potential for future shortages, and asserted that a voluntary independent third party approach is a key component in alleviating this public health crisis.
The generic pharmaceutical industry has been a leader in addressing this vital issue, spearheading the development of the Accelerated Recovery Initiative (ARI) — an unprecedented multi-stakeholder undertaking designed to speed the availability of critically needed drugs that are in short supply. GPhA is working with entities across the supply chain to implement the ARI and other recommendations to increase communication and strengthen our collective ability to supply patients with the medicines they need.
“As members of the public who also are affected by shortages, the generic pharmaceutical industry is acutely aware of the distress caused to patients, families and clinicians by the shortage of critical drugs,” said Ralph G. Neas, President and CEO of GPhA. “GPhA has been working closely with Members of Congress, the FDA and the Administration to find suitable solutions that accelerate the availability of critical drugs in short supply. Drug shortages represent a complex, multi-faceted issue and our industry has, and will continue, to work tirelessly to be part of the solution.”
The Accelerated Recovery Initiative calls for:
An independent third party to gather current and future supply information from stakeholders for products identified as meeting the critical criteria;
That information to be used to determine current and potential supply gaps, with a focus on those products where a shortage is expected to last longer than 90 days; and
A high-level SWAT team to be formed within FDA with the ability to quickly respond to critical shortages and work with the current Drug Shortage Staff expanded through President Barack Obama’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. GPhA is working closely with Congressional committees and the FDA to ensure that all initiatives are mutually reinforcing and complementary.
The ARI will maintain robust competition, and will not in any way deal with pricing information. It will also require prior approval by the Federal Trade Commission and the Department of Health and Human Services. 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.