GPhA Receives Positive FTC Advisory Opinion on the Accelerated Recovery Initiative

PRESS RELEASE

GPhA Receives Positive FTC Advisory Opinion on the Accelerated Recovery Initiative

WASHINGTON, D.C. (AUG. 8, 2012) — The Generic Pharmaceutical Association (GPhA) today announced that it has received a positive advisory opinion from the Federal Trade Commission (FTC) on the Accelerated Recovery Initiative (ARI) — the generic industry's unprecedented multi-stakeholder initiative designed to accelerate the recovery of critical drugs in short supply to patients in need.

GPhA and IMS Health are now working closely with the Food and Drug Administration (FDA) to finalize the details of the initiative and begin operation of the ARI in the near future.

"Today's opinion is a critical step forward in addressing the shortages of needed medicines in our country," said Ralph G. Neas, President and CEO of GPhA. "We commend the FTC for their expeditious review of the ARI, and we now look forward to continuing to work closely with our partners at the FDA and IMS Health to advance this important initiative."

"While this remains a complex issue that cannot be solved overnight, this type of private-public sector, multi-stakeholder collaboration is exactly what is required to respond to this crisis," Neas added. "The ARI will enhance our ability to minimize the drug shortages currently afflicting health care professionals and patients, and potentially prevent future ones from occurring."

Specifically, the ARI is predicated on voluntary communication between, the FDA, 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 as well as manufacturers' production and release forecasts, to give the FDA a better understanding of current conditions and abilities to expand the supply of critical medications and potentially 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.

The ARI is part of GPhA's multi-pronged effort to ensure patients have access to lifesaving generic medicines. In combination with the recently enacted 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 U.S. drug safety, establish a more level playing field among all participants in the U.S. pharmaceutical supply chain and make certain that all Americans receive timely access to safe, effective and affordable generic drugs.

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 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org.

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