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. 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.
- Physician, pharmacist and patient groups, among others, have become increasingly concerned about shortages and/or discontinuation of production of life saving medicines. FDA data confirms that drug shortages are on the rise, increasing from 70 reported new shortages in 2006 and over 200 in 2010. The majority of these shortages have occurred in critical care drugs, oncology products and anti-infectives. Over the last year, approximately 77% of the drug shortages were parenteral products.
- In November 2010, pharmacist and physician groups held a ‘drug shortage summit’ with a wide spectrum of stakeholders including manufacturers, physicians, hospitals, pharmacists, wholesalers, GPOs, and others. While the discussions were polite, most stakeholders were more than willing to point fingers at the pharmaceutical industry, and more specifically the generic industry, since most of the products in short supply are available generically.
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.
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.
ARI 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.