US FTC grants positive Advisory Opinion to Rx-360
Will allow supplier quality and safety audit programmes planned by RX-360
The US Federal Trade Commission (FTC) has approved the joint supplier quality and safety audit programmes proposed by Rx-360, a consortium of pharmaceutical and biotechnology companies.
Under these programmes, consortium members will be able to share both prior quality and safety audit information and the costs of sponsoring further audits of common suppliers.
In response to a request from Rx-360 for guidance about the law enforcement implications of the two proposed supplier audit programmes, Michael Bloom, assistant director for policy and coordination, Bureau of Competition at the FTC said: ‘Because it appears that the audit programmes 1) do not require exchanges of competitively significant information, 2) contain protections to reduce Rx-360 members’ ability to use the programmes for anticompetitive ends, 3) protect audited firms from concerted misuse of the audit programmes; and 4) are likely to promote efficiency, quality, and safety, FTC staff have no present intention to recommend to the Commission that it challenge the implementation of either programme.’
Under the FTC’s Rules of Practice, companies can seek guidance from the Commission or its staff about specific business conduct they are considering, and what the law enforcement intentions of the Commission or staff would be. These advisory opinions are not binding on the Commission, the courts, other governmental organisations, or third parties.
‘This provides the organisation with the type of endorsement that will accelerate our growth, foster collaboration and better enable us to work toward our mission to protect patients around the globe,’ said Martin VanTrieste, chairman of Rx-360.
Rx-360 was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain.