Richard L. Friedman, Director of the Division of Manufacturing & Product Quality in the Center for Drug Evaluation and Research, in the FDA’s Office of Compliance was interviewed this week by BioPharm International, which can be heard by clicking here.
In this interview he discusses the FDA's secure supply chain pilot and expresses the regulatory agency’s support of Rx-360’s efforts. The discussion on the FDA’s secure supply chain pilot punctuated Rx-360’s current efforts to bring regulators and industry professionals together to implement new approaches to secure the drug supply chain.
Pilot participants will consist of 100 firms that meet certain criteria, including that they have demonstrated robust controls from the time of manufacture of their material produced outside of the United States, through the entire supply chain, to importation into the United States. Mr. Friedman stated that to be selected for the pilot program a company will demonstrate the security of their supply chain by "knowing all of the parties involved and… [show] integrity is maintained at all those stops along the way.” He later on explains,
”you’re only as strong as your weakest link in the supply chain."
When asked about Rx-360, Mr. Friedman said "FDA is very much in favor of industry’s cooperative efforts, such as Rx-360..." He went on to state that, “anytime we see these kinds of collaborative approaches by industry, we’re very heartened by them." He stated that each manufacturer must justify their audit approaches, whether that means using a company’s own resources or a combination of that and an external party such as Rx-360.
When asked about new technologies and techniques to prevent counterfeiting, Mr. Friedman discussed the merits of Photographic Libraries, which was an idea developed and adopted by several Rx-360 members. To learn more about Photographic Libraries, read the article from the last Rx-360 newsletter by clicking here.