Obama Endorsement 'Gift From Heaven' for Regulatory Initiative, Says CBER Official

Posted 04 October 2013 | By

"Harmonization" may be one of the biggest buzzwords in all regulatory policymaking, but for Michael Fauntleroy, it's not a buzzword-it's his job.

Fauntleroy, program manager for the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), is at the front lines of one of the most ambitious but least-talked-about harmonization programs.

Known as the Electronic Submissions Gateway (ESG), the program is intended to allow both FDA and Health Canada to accept electronic regulatory submissions using the electronic common technical document (eCTD) format.

The basic problem, as explained by Fauntleroy and his colleagues on a panel held at 2013 RAPS: The Regulatory Convergence in Boston, MA this week, is that physical data costs are far higher than electronic ones. Craig Anderson, global head of submission management for AstraZeneca, cited estimates showing costs to be 400% higher-at minimum. Those cost estimates, he said, were just for the cost of printing materials, and not the time savings or other benefits associated with working electronically.

And with the eCTD set to become mandatory for all companies in 2014, Fauntleroy had some other frank advice for people in the audience who work with outside regulatory consultants: "If you're dealing with a company and they don't have electronic submission capabilities, you need to re-evaluate that contract."

If the US and Canada could accept the same document formats through the same single system, Anderson said, it could facilitate collaborative reviews between authorities, allow for two-way communication through the gateway, and expand the use of common standards, starting a sea change in the pharmaceutical industry.

"It would be a huge win" to allow HC to use same submission data as FDA, Fauntleroy said, referring to the aforementioned benefits.

How a Decree Becomes a Regulatory System

But Fauntleroy's presentation also focused a great deal on something often left out of accounts of regulatory harmonization: the excruciatingly difficult process of actually bringing a program online.

And listening to Fauntleroy's account, it's a wonder the program ever got off the ground at all, let alone managed to almost be completed in less than three years.

Two problems threatened to kill the program from the very beginning, he said. The first was simply funding. Since much of the program was being run out of Health Canada, FDA was legally barred from giving money to the agency to allow it to do anything even if it helped both US regulators and US industry. "That was the hardest part," Fauntleroy said. Ultimately, they settled on a funding mechanism known as CRADA, which stands for Cooperative Research and Development Agreement, more often used to transfer technology between a US agency and a private company.

But the second problem was, well, people.

"How many people have had to deal with your information technology department-show of hands," Fauntleroy asked. "OK, now how many people wish they had a club they could wail on IT with?" Most hands remained raised as the audience laughed aloud.

Simply getting the technological framework in place was a massive undertaking, Fauntleroy recounted, and without a reason to accomplish tasks quickly the entire project risked stalling. Among the more technical aspects of the system: the ability to receive
gargantuan file sizes and the need for high levels of security to protect commercially confidential information.

Fauntleroy said the difference between the project's success and failure may well have been its origins. The Regulatory Cooperation Council (RCC), the umbrella project from which the common electronic submissions gateway (CESG) project emanated, was signed directly by US President Barack Obama and Canadian Prime Minister Stephen Harper.

That presidential endorsement was a "gift from heaven" to get government workers to take the initiative and get the project done and tear down barriers, Fauntleroy explained.

And with the barriers out of the way, the project is set to launch in January 2014, just 26 months after first being conceptualized. The infrastructure is already in place and being tested, which has already worked out several problems, Fauntleroy said.

So what will the future hold for the ESG? Plenty of ideas are already in the works, he said: New submission types, redundant systems to hopefully ensure 100% uptime, a disaster recovery site and perhaps even new agencies to participate. Fauntleroy said talks are already occurring with the US Veterans Administration to become involved, though the purpose and extent of that cooperation is still unclear.


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