At the request of the U.S. Food and Drug Administration IWLA recently debriefed more than 30 FDA attorneys, economists and compliance specialists on the distinguishing factors between third-party logistics providers and wholesalers of prescription drugs in relation to the definitions found within Drug Quality and Security Act.
IWLA Washington Representative Pat O’Connor was joined by many IWLA-Members (Ann Christopher, vice president & corporate counsel, Kenco Logistic Services; Emily Johnson, corporate counsel, healthcare compliance and Suzanne Young, director, global healthcare compliance, UPS Supply Chain Solutions; Jim Saponaro, vice president life sciences, Americas, Exel; Val Dodd, president healthcare logistics, Genco; and Dave Bode, vice president, health care solutions, DSC Logistics) to provide the expert testimony during the brief on Feb. 11, 2014.
The group highlighted unique characteristics of U.S. third-party logistics providers in the, including their role, processes, value-added services and the differences between 3PLs and wholesalers. At the close of the brief, the group issued two requests to the FDA:
- The 3PL sector requests that the FDA issue a guidance statement explaining that states are preempted from establishing licensure programs before the federal standards are released and that existing 3PL licensure schemes, including licensure as a wholesaler, are preempted and 3PLs are “deemed” licensed.
- The 3PL sector is eager to assist FDA with development of national licensing standards for 3PLs with the goal of expeditiously developing and implementing a 3PL licensure framework and standards.
IWLA will continue to build its relationship with the FDA and to provide FDA leaders solutions for implementing the Drug Quality and Security Act to perform as intended: protecting the safety and security of the U.S. pharmaceutical supply chain.