Issues

GPhA Position

As members of the public who also are affected by shortages, the generic pharmaceutical industry is devoted to working with all stakeholders to minimize current shortages and mitigate factors that could contribute to future shortages. We are acutely aware of the distress caused to patients, families and clinicians by the shortage of critical drugs. 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 generic pharmaceutical industry has spearheaded the development of an unprecedented multi-stakeholder tool, which we believe will accelerate the recovery of certain critical drugs in short supply to patients in need. This proposal, which we have labeled the Accelerated Recovery Initiative, or ARI, can be utilized by all stakeholders involved in the manufacturing and distribution of vulnerable drugs in shortage — including, but not limited to manufacturers, wholesalers, distributors, Group Purchasing Organizations (GPO’s) and the FDA — in order to accelerate the recovery of critical drugs in short supply to patients in need. In addition, this multi-stakeholder approach will provide additional information to focus on decisions and actions proposed by regulatory agencies and their potential impact on critical supply.

Key Points

Background

ARI is predicated on voluntary, confidential communication between an independent third party and pharmaceutical companies involved in the manufacturing of generic injectable drugs in shortage. In addition, a multi-stakeholder approach including participation from the wholesalers, distributors, GPO’s and the FDA will provide information that will be critical in assuring a focus on real-time decisions. This initiative will not in any way deal with pricing information, and to ensure compliance with anti-trust law, it will also require prior approval by the Federal Trade Commission (FTC) and the Department of Health and Human Services. The type of information gathered and disseminated will improve visibility and communication between the FDA and industry relating to current and potential drug shortages.

ARI also is designed to provide a more effective communication conduit between the manufacturing community and the FDA. The agency is currently expediting regulatory reviews and working closely with manufacturers. However, there is still more that must be done, and manufacturers would be aided by a formal process specifically designed to facilitate communications related to drug shortage issues. The industry strongly encourages the establishment of a high-level FDA drug shortage management team, which would include representation from key agency offices. This team would provide an avenue for timely access to FDA decision makers by the pharmaceutical industry to review strategies for addressing regulatory agencies concerns and their potential impact on critical supply or for averting drug shortages. This high-level FDA team would also be empowered to evaluate issues such as expediting reviews of pending supplements, which enable industry to address shortages of critical drug products.

GPhA is committed to working with the FDA and all stakeholders to minimize current drug shortages and prevent future shortages from occurring. Nothing is more important to our industry than ensuring patients have access to their lifesaving generic medications, and with a joint effort among all involved, we believe we can make a significant step toward accomplishing this goal.