“A lot of our members are getting pushback from their own customers,” who are asking them to guarantee that a certificate will be provided on July 2 “but the companies are hesitant to do that because we know for a fact that the FDA won’t be” issuing certificates, John DiLoreto, executive director of SOCMA’s (Society of Chemical Manufacturers Association) Bulk Pharmaceuticals Task Force, told in-Pharmatechnologist.com.
Many European customers of US API manufacturers “are already looking for new sources of product” and the US companies are getting “frantic,” DiLoreto said.
The US FDA in January sought an exemption from the written requirements. But the European Commission took seven months to approve Switzerland’s exemption request, and the review could even be more complex for the US, so it’s unclear whether the review will be done by the July 2 deadline, DiLoreto said. The new requirements are part of the EU’s Falsified Medicines Directive, which was adopted in July 2011 and which member states had to start implementing last month.
“The EU folks have made it clear that they have no intention of extending the July 2 deadline or making any exceptions,” DiLoreto added. “If you’ve only got a couple of countries that will provide individual certificates, and only a couple with an exception in place, where are they going to get their product from? All in the EU? It’s doubtful.”
But despite “holding the line” for now, “when June 30 rolls around that may change because this could be politically devastating in a lot of respects,” DiLoreto added.
And despite inquiries from SOCMA, the FDA has not revealed any alternative plans if its exemption request is not completed by July 2. The FDA did not respond to a request for comment.
The FDA “knew about this a year ago,” he noted, but when SOCMA asked about the issuance of GMP certificates during the GDUFA (Generic Drug User Fee Act) negotiations, the FDA said they were not interested as there were “some legal issues.” The timeliness of issuing the certificates was another problem because of the delay between when the inspection is conducted and when the certificate would be issued or a notification would be posted online.
“We’d like to see more harmonization between the EU and FDA because so many companies are global,” DiLoreto said. “Movement of product would be easier if they’re harmonized from a regulatory perspective.”
GDUFA Monitoring
In addition to the EU deadline, SOCMA also will be closely monitoring the implementation of GDUFA, particularly in regards to inspections conducted at foreign facilities.
In the past, US API facilities were being inspected at a rate of about one every 2.5 years, but foreign facilities were only being inspected between once every 11 years and once every 14 years, and “that’s if they’ve been inspected at all,” DiLoreto said.