Hahn Stresses Product Safety
In a 1/31 interview with Politico, new FDA commissioner Stephen Hahn stressed product safety as he talked about drug importation, generic drug approvals, cannabidiol products, and the coronavirus. Hahn was confirmed one day before the Trump administration announced its plan to allow states to import cheaper drugs from Canada.
“There is a compelling reason that the American people want us to consider this and so we’re going to have to figure this one out and balance both of these issues (safety and affordability),” Hahn declared. The commissioner reportedly talked up the agency’s role in approving more generic drugs as a way to lower drug costs, saying “the American people are expecting us to do more.”
As FDA works on details to finalize the importation rule, Hahn said it will be open to addressing criticism that states can’t save money bringing in drugs from Canada if the pathway is too burdensome. However, he said safety is paramount, noting that “our primary concern is the protection of the drug supply.”
Addressing criticism that FDA has been moving too quickly to approve drugs without adequate evidence, Hahn said, “at the end of the day there is this balance between the gold standard and being efficient and getting things in people’s hands. I’m totally confident in the agency’s ability to do that.”
On the issue of cannabidiol products, he noted the dearth of solid data on how safe and effective CBD actually is. He said the CBD challenges have fueled larger discussions about how to better regulate the dietary supplement market. “It will be something else next,” he said. “We don’t want to overstep our bounds but we want to make sure that safe and effective products are in the hands of people.”
Finally, looking at the worsening coronavirus scare, Hahn said there have not been reports of disruption of the supply chain or shortages, but FDA is looking ahead and planning for “what could potentially be the most serious of scenarios.” Currently, he said, FDA inspections in China are being conducted on a case-by-case basis. The ability to monitor things in China could become more difficult as the State Department expands mandatory evacuation from affected areas of the country.