U.S. Federal Trade Commission Grants Positive Advisory Opinion to Rx-360, Further Enabling Audit Sharing Programs
Washington, D.C. - 16-September-2010 - At today's Rx-360 Open Meeting in Darmstadt, Germany, hosted by Merck KGaA, Ms. Joanne Lewers, Partner at Drinker Biddle & Reath, the consortium's Legal Counsel and Secretariat, announced that the U.S Federal Trade Commission (FTC) has provided a positive Advisory Opinion pertaining to the organization's shared auditing programs.
The positive opinion states that, "FTC staff has no present intention to recommend to the Commission that it challenge the implementation of either program." This support further endorses the Consortium's efforts to develop programs within the legal parameters of anti-trust and anti-competition laws, and advances Rx-360's ability to proceed with plans to implement its audit sharing programs.
Martin VanTrieste, Rx-360 Chair, commented, "The positive Advisory Opinion is great news. It provides the organization 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."
From the FTC Web Site:
http://www.ftc.gov/opa/2010/09/drugfidelity.shtm
The staff of the Federal Trade Commission has advised a consortium of pharmaceutical and biotechnology companies that it has no present intention to recommend that the agency challenge the Consortium's planned joint supplier quality and safety audit programs. Under these programs, consortium members will be able to share both prior quality and safety audit information and the costs of sponsoring further quality and safety audits of common suppliers.
In an advisory opinion letter responding to a request from the Rx-360 International Pharmaceutical Supply Chain Consortium, the FTC staff states that it appears that the audit programs: 1) do not require exchanges of competitively significant information, 2) contain protections to reduce Rx-360 members' ability to use the programs for anticompetitive ends, 3) protect audited firms from concerted misuse of the audit programs, and 4) are intended and likely to promote efficiency, quality, and safety. Accordingly, FTC staff advises, it has no present intention to recommend to the Commission that it challenge the programs.
Rx-360 asked the FTC staff for guidance about the law enforcement implications of the two proposed supplier audit programs and supplied information to the staff about the proposed programs. Under the FTC's Rules of Practice, companies can seek guidance from the Commission or its staff about specific business conduct they are considering undertaking, and what the law enforcement intentions of the Commission or staff would be. These Commission and FTC staff advisory opinions are not binding on the Commission, the courts, other governmental entities, or private parties.
The advisory opinion can be found on the FTC's website and as a link to this press release at:
http://www.ftc.gov/os/2010/09/100916bloomletter.pdf
The staff contact is Michael Bloom
Bureau of Competition
+1 (202) 326-2475