While it has only been a few months since the first American was diagnosed with COVID-19, the scope of the pandemic is one which we have never experienced before. Throughout, it has become abundantly clear that our nation’s ability to effectively respond to this once-in-a-lifetime crisis depends on the public and private sectors joining forces, maintaining constant coordination, and working together to identify operational and regulatory barriers impeding access to medicines and medical supplies.
It has been clear for some time that the pharmaceutical supply chain has been concerned with meeting the November 27, 2019, saleable returns milestone. As the HDA’s Research Foundation’s annual Serialization Readiness Survey (conducted in May) notes, 79 percent of manufacturers have concerns with the viability of the Verification Router Service (VRS), while 82 percent of distributors are unsure about meeting the requirement.
As the summer winds down, HDA is hard at work planning our 2018 Traceability Seminar, which will take place three weeks earlier, on October 17–19 at the Renaissance Washington, DC Downtown Hotel. As the industry passes the halfway mark for DSCSA implementation, our 2018 agenda leverages HDA and our members’ unique expertise to help fellow stakeholders answer critical questions while planning for the multiple milestones ahead.
On February 28, FDA hosted its third and final public meeting in a series focused on "Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act [DSCSA],” bringing together a broad group of stakeholders, including manufacturers, distributors, dispensers, hospitals and service providers.
In an opinion piece published today in the Capitol Hill newspaper, The Hill, HDA and NACDS called on members of Congress to honor its commitment to protecting patients and the safety of the supply chain by rejecting any proposal that would call for the importation of prescription drugs from foreign markets.