After months of navigating nationwide shortages of drugs and medical supplies, Robert Califf, MD, the 25th commissioner of the FDA, addressed these issues and outlined the role the agency is taking to address them.
"In a healthcare system as complicated and fragmented as ours, the steady advance of logistics and sophisticated use of technology and human systems has been essential to supplying needed medical products to the right patients at the right time," Dr. Califf said at a Nov. 15 meeting with the Healthcare Distribution Alliance Board of Directors. "Despite the amazing progress in logistics, there are dangerous and troubling issues involved in our ongoing shortages and vulnerability of our essential low-cost products, including generic drugs, commonly used low-cost devices and personal protective equipment."
The Healthcare Distribution Alliance is an organization that represents healthcare and pharmaceutical distributors across the U.S. It also monitors orders and inventory of critical devices and medication availability. Dr. Califf noted that as such, it has "a critical role to play in predicting, preempting, and ameliorating the shortages that are plaguing our healthcare system."
He thanked HDA leaders for their commitment to providing aggregated data about the regarding distribution of COVID-19 vaccines and encouraged them to take it a step further by also providing easy access to information about the distribution of COVID-19 therapeutics, for instance.
"This kind of added transparency, which comes with low risk for your members, can have an enormously positive impact on public health," Dr. Califf said.
Meanwhile, the FDA is taking multiple steps to address areas of the healthcare supply chain, including by collecting and making available more data on product quality and compliance; encouraging the adoption of new, efficient technologies for manufacturing and distribution; and developing incentives for compliance.
The agency has also developed a Quality Management Maturity program, "which will incentivize drug manufacturers to voluntarily invest in quality culture," Dr. Califf said.
Despite these efforts, achieving a synchronous, transparent and informative picture of the healthcare supply chain will take multiple partners alongside the FDA, Dr. Califf underscored.
"You and your members have a stake in preventing shortages and keeping a robust supply chain through transparent information sharing, of course, but also to engage in practices that raise quality, including, for instance, negotiating contracts that are fair and include guarantees to offer predictable revenue flows…" he said. "This might mean that you pay more for resilient supply partners. This will not only result in improved patient access to high quality, low-cost medical products, it will be good for business."