The US Food and Drug Administration (FDA) is headed toward a marked change in compliance policy in the coming years as the result of rapidly surging imports of pharmaceutical, medical device and biologics products, according to Mark Roh, regional food and drug director for FDA's Pacific Region. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies.
The Need for Change
In a presentation to the Regulatory Affairs Professionals Society's (RAPS) San Francisco membership chapter on 27 July 2012, Roh said the rate at which products were being imported from overseas manufacturing facilities was fast outstripping FDA's ability to effectively exercise oversight.
Some of the largest US trading partners are projected to experience enormous growth trends in imports, Roh said in his presentation. China in particular is expected to experience a 426% growth in exports by 2020, while India (+465%) and Mexico (+159%) are projected to exhibit similar percentage increases, though on a smaller overall scale.
This could have huge ramifications for the US, which already imports approximately 10% of all products regulated by FDA. Roh explained the US is expected to see growth rates between 5% and 8% during most years, with estimations going as high as 15% during some years.
'Current Import Regulatory System is an Honor System'
These complexities are proving to be taxing to FDA appropriations and industry-supplied resources, both of which are being stressed by a number of factors, explained Roh.
"Workload has outstripped FDA resources," said Roh, who added, "Insufficient legal authorities and enforcement tools" had also hamstrung the agency's ability to act. "[The] current import regulatory system is an honor system."
Increasing trade volume, complexity, numbers of foreign facilities, regulatory complexity, security threats, supply chain complexity and opportunities for fraud are all among the agency's top concerns, he explained.
Better Use of Existing Resources
Though Roh called on industry to support the idea of new authorities to support legislation boosting FDA's ability to secure the supply chain, including increased authorities, information and resources, he said the agency is more focused on correctly using the resources it has to better promote compliance.
One of the perennial issues FDA faces is the number of inspections corresponding with an "Official Action Indicated" warning letter. Many of the warning letters include issues related to Corrective and Prevention Action (CAPA) deficiencies, and Roh said the agency is "consistently seeing a high volume of the same issues year after year."
One of the problems, explained Roh, is "The relationship between quality and compliance -historically more focus [has been on] on compliance [rather] than quality," resulting in little available information regarding comparative quality.
"We must ask whether we are using the right methods to improve device quality," added Roh. Because of the agency's resource limitations, it is only able to inspect approximately 34% of domestic manufacturing facilities and 5% of foreign manufacturing facilities. Of those facilities inspected, 3% failed to achieve regulatory standards in 2011, said Roh.
Enter: The Case for Quality
FDA's proposed solution to this is being dubbed "The Case for Quality"-a tripartite approach consisting of a focus on quality, enhanced transparency and stakeholder engagement.
This shift will see FDA focusing less on compliance activities and more on the quality practices instituted by a company under the theory that the latter will naturally lead to the former. For example, companies utilizing root cause analysis and designing quality into a product are unlikely to experience recurring compliance issues, whereas a company that fixes compliance issues on a piecemeal basis is likely to experience regular problems and recurring product failures.
Roh said FDA will be reaching out to stakeholders to better assess short-term and long-term goals for the program, as well as how it might eventually be structured. While the approach is currently device-focused, particularly on Quality System Regulations (QSRs), it could eventually include drugs as well.
Still, said Roh, it's clear "FDA can no longer act as the industry quality control unit at the border… FDA's second century will be international."
A New Recall System?
Roh also noted FDA's Office of Global Regulatory Operations and Policy has been exploring the possibility of implementing what he called a, "Single FDA recall system which encompasses all domestic and global correspondence and distribution information."
This system might involve scrapping all current recall regulations and re-establishing them as guidance documents or pushing for new, integrated legislation to accomplish the same task. Roh said the agency is also interested in creating a feedback loop between information received by the agency, FDA's ability to conduct a risk assessment based on the information and how information is both fed out of the system and shared with other regulatory and public health agencies across the globe.
This would eventually enable the agency to have a better-structured and more transparent system, explained Roh, with FDA providing a, "Flexible, comprehensive, daily updated database structured for analysis" by both FDA and industry.