Real world evidence and data privacy regulations were among the hot topics at the 2018 Rising Leaders Conference on Healthcare Policy.
A source of much corporate concern, the European Union’s General Data Protection Regulation (GDPR) finally went into effect on May 25. The sweeping law applies to every organization that handles EU citizens’ personally identifiable information — EU-based or not — and prevents such organizations from using consumers’ data without their explicit consent.
And while an “American GDPR” is currently a political nonstarter, as Janrain CEO Jim Kaskade explains, “The Cambridge Analytica data misuse has brought a lot more awareness to the data privacy issue, which will force a hard new look at how personal data is being handled by businesses in the U.S.”
In California, for instance, data privacy advocates are pushing to get The California Consumer Privacy Act of 2018 on the ballot for the state’s midterm elections in November. If passed, the initiative would impose strict regulations on how companies are allowed to collect and use consumer data.
While government-imposed regulations like the GDPR and The California Consumer Privacy Act bear upon the operations of companies in nearly every industry, they have a particularly pronounced effect in the pharmaceutical industry. This was made quite evident at the recent 2018 Rising Leaders Conference on Healthcare Policy, during which a variety of distinguished presenters spoke to the immense importance of strategic data use in both the pharmaceutical and broader healthcare spaces.
Streamlining the FDA’s Approval Process
As part of a panel discussion on the first year of Scott Gottlieb’s tenure as the Commissioner of Food and Drugs, EngelNovitt Founder and Managing Member John Engel addressed the FDA’s growing interest in incorporating real world data (RWD) and real world evidence (RWE) into its drug and medical device approval processes.
As summarized by law firm McDermott Will & Emery, RWD “relates to patient health status and/or the delivery of healthcare routinely collected from a variety of sources, including electronic health records (EHRs), claims and billing data, disease registries, patient-generated data, etc.” RWE, on the other hand, is the “clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”
Gottlieb, Engel pointed out, has been a strong proponent of RWD and RWE from the get-go, and has pushed for a series of reforms that would allow the FDA to give as much weight to information collected in the “real world” as to information collected in clinical trial environments. Quoting Gottlieb’s September 19, 2017, speech to the National Academy of Sciences (NAS) at length, Engel highlighted the Commissioner’s work with the NAS as an example of what the future of drug and medical device approval should look like.
“Should a product be marketed based on a dataset that speaks to a limited and rigidly constructed circumstance, when the clinical use, and in turn the evidence we might have to evaluate the product, could have been far richer, far more diverse, and more informative?” Gottlieb asked.
For both Engel and Gottlieb, the answer is a definitive, “No.” Introducing RWD and RWE into the FDA’s approval processes will not only improve the Administration’s decision-making, but may actually compress timelines and reduce costs. At the end of his remarks, Gottlieb reported that use of RWD and RWE had, “in some cases, sav[ed] one to two years of development time.”
Balancing RWD and RWE with Data Privacy
The diversification of FDA inputs isn’t without its challenges, however. Engel expressed concern that the use of RWD and RWE and emerging data privacy regulations may be on a collision course. Venable LLP Partner Stuart Ingis articulated a similar concern in a talk entitled, “Facebook, Privacy, and Health Communication: What Happens Now?”
According to Ingis, much of the data caught up in this regulatory tug-of-war is either inaccessible or not easily digestible by the lawmakers who are the ultimate arbiters of what organizations like the FDA should and should not be able to do. These are new and incredibly complicated questions — even for pharmaceutical industry insiders — and most lawmakers simply aren’t equipped to make the ideal decision. 4As Executive Vice President Dick O’Brien made a similar point early in the day, citing Congress’ brief consideration of halving the tax deductibility of pharmaceutical advertising as proof.
Like Ingis, O’Brien suggested that self-regulation is the best way forward, and that patients are more concerned about nefarious activities à la Cambridge Analytica than they are about targeted pharmaceutical advertising.
Exciting Times Ahead
Ultimately, the major takeaway of the conference was that the answers to many of these questions remain unclear. Things like real world evidence and data privacy protocols are part of a new frontier in healthcare, and such exciting progress rarely comes without growing pains.
There are fine lines to be drawn between the healthcare industry’s various competing interests, but as long as their placement is being guided by the likes of those I saw speak at the Rising Leaders Conference, I’m fully confident of a future that benefits patients, healthcare providers, and pharmaceutical developers in equal measure.