FDA, EMA leaders address barriers, 'big projects,' and Brexit

For the US Food and Drug Administration (FDA), Commissioner Robert M. Califf, MD, said a "big project" has been working “to make sure that we have a work force that can deal with technology as it evolves​.”

Specifically, Califf addressed the difficulties of evidence generation. “When we have really good evidence, there is still controversy​,” he explained. “It’s quite noticeable that our evidence generation system isn’t keeping up with the pace of technology​.”

One issue is that the traditional clinical trial doesn’t include a representative population. However, with eHealth records Califf said “the fabric of data already exists​,” which is the key to generating an evidence-based healthcare system.

“We need clinical trials done in practice using integrated health systems and taking advantage of data that already exists​,” he added.

Califf explained this will take cross-center coordination – a goal of the FDA’s new Oncology Center of Excellence​ (OCE), which he said will put the patient at the center. “Putting patients at the center is a major focus at the FDA​,” he said. “We’re all learning to do this better​.”

‘Then we have globalization’​

As the industry shifts towards patient centricity, Califf also added that there’s been “a dramatic shift​” in the places where APIs are being made. “Then we have globalization​,” he quipped, as he explained the next challenge the administration is working to overcome.

“As we look at the global situation given the overwhelming amount we have to do at the FDA … It’s critical that countries form groups that can work together​,” said Califf. “The FDA can’t integrate separately with every country in the world​.”

“The model of regulators working in isolation is no longer attenable​,” added Anil Arora, Assistant Deputy Minister, Health Canada, and Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary, executive level group of medicines regulatory authorities worldwide working to tackle these issues, among others.

“We have to have relationships with India and China​ … We need to all have assurance that quality is the same that we would expect in our home country​,” said Califf, who alluded to “recent events in the UK​.”

‘Brexit’ and business as usual​

“As all you know the UK system voted for Brexit,” ​began Emer Cooke, MBA, European Medicines Agency (EMA), Head of International Affairs. “And this is a decision that affects a lot of the staff of the agency, both personally and professionally​ … I think we are all shocked by it​.”

Cooke explained that while it’s a period of uncertainly, there are three things that she can say for certain:

“One is that it’s far too early to say what’s going to happen. Two, we will continue with our business as usual; there is no immediate change, apart from the emotional shock. Third, our job is to protect and promote public health and we will continue to ensure the safety, efficacy, and the quality the medicines and access to the patients that need them​.”

“Finally wanted to say that were a very strong agency​,” she added. “I’m confident that whatever happens we’re going to be able to deliver on our core business​.”

Cooke stressed that the organizations need to make sure that products are being developed appropriately and get to patients as quickly as possible. However, she admitted that it can be difficult for smaller companies to “cope with the complexities of the European system​.”

In order to help companies navigate these complexities, Cooke explained that the EMA is working to create a portal, “so it’s clear what has to be done​,” specifically as it pertains to GMP. The agency is also creating “an action plan going forward​” for gene cell therapy.

“I would be remiss to not say how much effort we’re devoting to international cooperation​,” she added.

Notably, the EMA and FDA have been working closely to create mutual recognition of GMP inspections, which Cooke said would be “a big step forward​.” She added that the agency is “hoping for some successes by the end of the year​.”

“The immediate challenge is to keep going in the face of unexpected events​,” concluded Cook, “and I’m quite confident that we will​.”