In her Tuesday Keynote session, The Importance of Product Integrity--a Regulatory Perspective, Ms. Ricki Chase, Director of Investigations for the U.S. FDA's Chicago office, sounded an encouragement--and several warnings--to the pharmaceutical industry with regard to the new regulatory landscape.
"We have to do a better job," she said. "A global market requires a global solution." She referred to the wakeup call of the 2007-08 adulterated Heparin tragedy as an example of what can go wrong with an out-of-control supply chain.
Chase detailed the now-familiar ways that drugs can be adulterated, diverted or counterfeit. She emphasized that each member of the supply chain needs to become part of the solution by practicing and upholding GMPs at their own facilities. She also cautioned attendees to have a more compassionate and global view of drug quality. "Your standards must be the same whether the drug will be sold in the U.S. or China," she said.
Chase pointed out industry's responsibility to help detect integrity compromises anywhere in the supply chain, and to notify FDA so that weaknesses and vulnerabilities in the drug supply chain can be addressed, as the Drug Supply Chain Security Act is implemented.
Lastly, she urged the audience to "demonstrate both personal and corporate integrity," and thus become part of the drug integrity solution.
