US officials' new take on import rules may mean APIs destined for trials will only be allowed into the country if they are listed in an effective IND application, according to Clinipace QA chief Nikolas Burlew.
Burlew made the claim during a recent webinar, suggesting that a new legal reinterpretation by the US Food and Drug Administration (FDA) and customs officials means importation of drug actives will only be permitted if they have an IND listed in the EES (Establishment Evaluation System).
The problem with this, according to Burlew, is that such listing typically occurs only 30 days after a request for an IND number has been submitted, which he believes could slow imports, delay trial timelines and possibly mean it takes longer to get drugs to market.
Previously, active pharmaceutical ingredients (APIs) could be imported prior to an IND submission for a clinical trial and there were times when the FDA even agreed to provide an IND number in some cases before the IND was actually filed.
However, according to Burlew, import rules for trial supplies changed after companies began importing APIs with IND numbers but then did not use them in the referenced IND applications.
So, he continued, the FDA and customs officers “went after those trying to skirt the system,” especially as high-profile supply-chain issues, such as the distribution of fake Avastin , caused increasing concerns.
“We have collectively worked with dozens of imports under INDs that were not yet effective over the years,” Burlew said. “And while I will concede that it may be that the rules just weren’t being enforced – the result is still a change in their effective implementation.”
FDA spokesman Steven King told in-Pharmatechnologist.com that the agency is “unaware of any change in interpretation of the regulations with regard to import of API for investigational use.”
But Burlew said he’s heard conflicting reports from the FDA.
“When we first became aware of this issue, we spoke with FDA District Compliance Officers who pointed us to CDER and would not answer any questions. We tried multiple times to speak with folks in the Import Branch and never were afforded a returned call or email,” Burlew said.
“We ultimately spoke with the Ombudsman to describe what we saw as the unintended consequences of this apparent change. And while they were very receptive to the information, we never heard back regarding any follow-up.”