The Generic Pharmaceutical Association (GPhA) has proposed a multistakeholder initiative to minimize current and future critical drug shortages. 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. The announcement follows a series of Congressional, executive, and industry responses to address the recent problem of drug shortages.
The proposal, known as the Accelerated Recovery Initiative (ARI), is based on voluntary communication between an independent third party and stakeholders involved in the manufacturing and distribution of generic injectable medications currently in shortage. It is designed to use real-time supply and distribution information to be given to stakeholders, including, but not limited to, manufacturers, wholesalers, distributors, group purchasing organizations, and FDA, to provide a better understanding of current conditions and to expand the supply of critical medications.
“The generic industry has taken a leading role in responding to this crisis, and the ARI marks a significant step in those efforts,” said Ralph G. Neas, president and CEO of GPhA, in a Dec. 15, 2011, press release. “This type of multistakeholder 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 ARI 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 will 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. A high-level SWAT team will be formed within FDA with the ability to quickly respond to critical shortages and work with the current Drug Shortage Staff that was expanded through the drug-shortage initiative ordered by President Barack Obama.
This voluntary initiative will take place in conjunction with the work currently being done by FDA to expedite regulatory reviews and to work closely with manufacturers. “It will maintain robust competition and will not in any way deal with pricing information,” said GPhA in its statement. “It will also require prior acceptance 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.”
The ARI was discussed as part of GPhA’s testimony by Neas before the Senate Committee on Health, Education, Labor, and Pensions on Dec. 15, 2011. Neas acknowledged that while many factors contributed to the current drug shortages, roughly half of the reported shortages have been attributed to problems associated with the manufacturing and release of generic sterile–injectable products. He said that the ARI is being supported by both GPhA and non-GPhA members, which collectively account for approximately 80% of the generic sterile–injectable products sold in the US. The ARI seeks to address the most critical drugs among the 200 identified by the FDA Drug Shortage Staff.
See related Pharm Tech articles:
Drug Shortages Create Crisis for Manufacturers, Regulators (Pharmaceutical Technology)