After being called off because of the Covid-19 pandemic, the FDA’s public meeting to discuss data strategy, an issue that is vital to the future of health care in the United States, is being held — virtually, of course — on Tuesday, June 30.
Like many regulatory bodies, the FDA innovates at a far slower pace than the private sector. This lag time has made it difficult for the FDA to develop a technology strategy that remains relevant from inception of a new drug to deployment.
This wasn’t always the case. Looking back to the mid-1990s, the FDA was a technological pioneer, putting in place the first systems that let pharma companies electronically report adverse effects. This new technology allowed the FDA to monitor the safety and efficacy of products.
The reason for the agency’s slowdown? Health care data is compounding faster than ever before, having grown 878% since 2016 and expected to continue to grow exponentially. The pharmaceutical and medical device industries are seriously exploring — and quickly adopting — new technologies to cope with the resulting unprecedented level of data complexity. This meeting will hopefully set the FDA on course to catch up and more effectively work with industry in the technology era.
What will the meeting address?
The meeting will focus on three main areas of discussion: standards and policy; data security, privacy, and management; and data strategies and data sharing. Attendees have been invited to help guide the FDA’s response to a host of challenges facing the pharma industry today.
These include: How do we handle the challenge of moving from static datasets to streaming datasets? How can we ensure data privacy and protection? How can a new data strategy help the FDA and the industry facilitate private and secure interactions with the global marketplace and other regulatory agencies?
Legacy systems are hindering innovation
Another challenge facing the industry is entrenched legacy systems on the part of both the FDA and pharma companies. It is expensive and time-consuming to integrate the antiquated systems with newer technologies. The pace of innovation is requiring a fundamental restructuring of underlying tech stacks as well as the FDA’s data strategy approach.
To ease this difficulty and ensure future compatibility, the FDA and pharma companies around the world will need to agree on tech integration and further advancements, with the FDA following in pharma’s footprints, since the industry is already taking strides to digitally transform and modernize its data strategy.
What will the FDA ultimately do?
While it’s impossible to predict the future — few saw the looming Covid-19 pandemic in early January — it’s safe to predict three ways the FDA will likely focus its data strategy after the public meeting.
The first involves the technological underpinnings of the agency itself. The on-premises, license-based software model is dying out, making way instead for flexible, nimble cloud architectures. This shift would open the door to further data handling possibilities, like analysis of streaming data.
The second is a move to software as a service and cloud-based model that will enable the FDA to access data on a much deeper level. Traditionally, the agency has been limited to relatively simple queries on static databases. The creation of a data lake depends on the elasticity of the computing infrastructure, since it stores massive volumes of both structured and unstructured data. Given the FDA’s mandate, you can bet that the FDA will need more of a data ocean than a data lake.
The third way involves a different approach to data analysis. The movement to data lakes makes it possible to analyze data in entirely new ways. Rather than static queries that seek to define parameters, agency staff will have access to advanced data tools that provide graph-based, intelligent querying that grows and evolves through machine learning and artificial intelligence. The question will no longer be “What are the adverse effects of this drug?” but rather, “Tell me the factors that influence the likelihood an individual patient will experience adverse effects from this drug.”
These three changes represent a fundamental change in the way the FDA manages, monitors, and uses data.
Securing the pharmaceutical data of millions of people
Data security should be top of mind for companies and regulators in the pharmaceutical sphere. The FDA needs to establish direct links with pharma companies to collect data, and those companies in turn have connections to each of their suppliers and trading partners. With that many links in the chain, the agency must carefully evaluate every pharma company’s security to comply with privacy regulations. It should also determine protocols to be followed after a data intrusion and the course for remediation.
There will also be many implications for the agency when the European Union’s General Data Protection Regulation and other similar regulations come into play. Privacy must be paramount as the data modernization strategy progresses. Legacy systems will need to interface securely with pharma companies around the world, obtaining the data necessary to perform queries while simultaneously maintaining spotless data privacy.
The long road ahead
This first public meeting — others haven’t yet been announced but are likely to happen — won’t yield immediate improvements. It may take several years to formalize and implement a new strategy. It will be worth waiting for: Long-term results of this initiative will be a regulatory body and industry that will work together more synergistically, leveraging technology to extract data and relevant insights that will improve the way drugs and innovative therapies are developed, tested, introduced, commercialized and regulated for the betterment of all.
Joe Rymsza is the vice president of global pharmacovigilance and regulatory technology at IQVIA.