The ARI, which was announced by GPhA in December 2011, is a voluntary initiative by the generics industry, which is designed to speed up the resolution of drug shortages for certain critical drugs, and is part of GPhA’s effort to ensure patients have access to safe, effective and affordable life-saving generic medicines.

The ARI aims to provide FDA with more production planning and supply chain information from generics manufacturers in order to enable FDA staff to work more efficiently and effectively to accelerate the recovery of critical drugs in short supply. Due to the sensitivity of the information, the ARI raises substantial antitrust concerns if this information were shared among competitors, because such information could facilitate collusion among drug manufacturers. For this reason, IMS Health was brought on board in April 2012 as an impartial third party to collect and transmit the data to FDA in a monthly report.

The FTC has concluded that the proposal appears ‘to limit the potential that the ARI might result in harm to competition’. The FTC mentioned that if safeguards introduced by GPhA were adhered to in practice then there would be no need for ‘an enforcement action to challenge the program’. GPhA safeguards include:

• Use of an independent third party to collect and transmit the data to FDA and that no other party, including GPhA, will have access to this information or any analysis derived therefrom.
• Other features intended to minimise the risk that the ARI could serve to facilitate collusion among drug manufacturers or cause other harm to competition, such as requiring binding commitments from ARI participants not to use the programme for anticompetitive ends.

The FTC opinion was marked as being ‘a critical step forward in addressing the shortages of needed medicines in our country’, according to Mr Ralph G Neas, President and CEO of GPhA. He added that ‘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.’ The GPhA requested an opinion from the FTC on 16 July 2012.

The GPhA reports that it is now working closely with IMS Health FDA to finalise the details of the initiative and is expected to launch the ARI programme by the end of September 2012.

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