Provide Covid Therapeutics Distribution Info: Califf
FDA commissioner Robert Califf says the Healthcare Distribution Alliance, which has provided aggregate information on the distribution of Covid vaccines from distributors into the field, could be of even greater assistance to FDA by also providing aggregate information on the distribution of Covid-19 therapeutics. “This kind of added transparency, which comes with low risk for your members, can have an enormously positive impact on public health,” Califf said in an 11/15 speech to the alliance’s board of directors.
Califf used the speech to review some of the ways the agency is responding to supply chain challenges. “There have been many supply chain disruptions of drugs as well as medical devices,” he said, “many of which have had a disproportionate impact on our most vulnerable populations, such as devices that are critical to pediatric and neonatal populations.”
Califf reviewed both what the agency can do and what it can’t do, noting that FDA cannot require a drug company to make a drug, increase production of a drug, or allocate a drug among lawful purchasers.
What it does do, he said, is work closely with manufacturers and others in the supply chain to understand, mitigate, and prevent or reduce the impact of intermittent or reduced availability of certain products.
“When we know there is a drug shortage or potential for a drug shortage,” he said, “we work to identify the cause and extent of the shortage and to determine whether other manufacturers are willing and able to fill that gap. We can also expedite inspections to bring facilities online to fill that gap and can expedite review of applications or supplements for products that could help prevent or mitigate a shortage.”
Califf said the timing of FDA learning about a potential shortage is a critical factor affecting its success since in recent years there has been a significant increase in demand for some drugs. Unfortunately, he said, the agency receives minimal information on demand for drug products, and any information it may receive is provided voluntarily, as the agency has no authority to require manufacturers to report increases in demand for any given drug.
“The current law requires certain manufacturers to notify us about manufacturing disruptions but not when excess demand may lead to a shortage,” Califf explained. “Having access to additional information would greatly hasten and enhance our efforts to work with industry to prevent and mitigate drug shortages.” He said the agency is seeking a change in the law to include notifying FDA about an increase in demand for a drug.
He also said Congress has provided even fewer shortage authorities for medical devices and said the notifications must relate to a public health emergency. “Until Congress ends the temporal limitation on FDA’s authority for device shortages, our domestic supply chain will remain vulnerable and patients will be at risk,” he declared. “These concerns extend to personal protective equipment, as much of the manufacturing has shifted back offshore.”