Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency. It is often described as the law that keeps citizens in the know about their government. Federal agencies are required to disclose any information requested under the FOIA unless it falls under one of nine exemptions which protect interests such as personal privacy, national security, and law enforcement.

Advera Health Analytics’ reputation has been built on providing our clients with timely and actionable insight from vast drug safety datasets.  And there are many challenges to providing these services, including how to clean and optimize the messy core data and how to build analytic tools that extract value from those data.  But one of our biggest challenges is making sure that we have the most up to date data possible.  Without that, we’re like a racehorse stuck at the gate – all raring to go but unable to step forward.

FDA provides access to the Adverse Events Reporting System (FAERS) data through quarterly data downloads or via its API system, OpenFDA.  In either case, however, the data releases are made on a significant delay.  For example, the most recent data available from FDA is through 6/30/2015.  For newly approved drugs whose safety profiles are unknown and/or developing, suffering a 4-5 month delay isn’t only unacceptable, it’s potentially deadly, and particularly ludicrous when considering the advancements in “big data” technologies.

To get around the deficiencies of FDA, whether due to their funding, resources or technology constraints, we routinely submit Freedom of Information Act (FOIA) requests directly to FDA to get the most up-to-date safety data on hot-button-topic and newly approved drugs.  FDA is then required to provide us with the most current data that they have on those drugs, usually through the date that they receive the request.

From the date that we request those data to the date that those data are made available to our clients is usually 3-4 weeks.  The bulk of that time is spent waiting for the data files to arrive in the mail.  Once we have the data, we clean and optimize it using our RxFilter process and then load the data to our site and run it through our analytics to try to identify emerging safety issues.

For example, on October 9th we requested data through a FOIA request on Chronic Lymphocytic Leukemia (CLL) drugs.  We received those data from FDA on October 26th and fully processed and analyzed the data by October 27th.  Earlier this week we published a Drug Safety Monitor report summarizing our findings from those data which included the following Actionable Intelligence:

Our analysis showed a high first-time RxScore (97.15) and RxCost per prescription ($791.56) for Zydelig, making it currently the least safe treatment option for this indication. In addition, Imbruvica showed an increased RxScore (+2.24 to 90.55) and RxCost per prescription (+$63.93 to $247.8). In addition, three new Active RxSignals (Imbruvica/ventricular fibrillation, Zydelig/pulmonary thrombosis, and Fludara/drug-induced liver injury) as well as seven new Watchlist signals were generated from these new data.

A few weeks earlier, we published a Drug Safety Monitor report highlighting new data we have received from a FOIA request covering the Hepatitis C medications which included the conclusion that Viekira-Pak was showing signs of being less safe that Harvoni or Sovaldi.  That report was followed about a week later by an FDA safety warning on Viekira Pak. In actuality, we’ve been raising concerns about Viekira Pak’s safety since early last year – 10 months prior to FDA’s warning.

The process of submitting, receiving, and processing data from FOIA requests is expensive and time consuming.  But it’s also a key component to making sure our clients have the most up-to-date data and actionable intelligence on drugs of interest.

The one question we get all the time from our clients is “If FDA has these data in a format that they can give you upon request, why don’t they just accelerate the public release of all of the data?”  That’s a very good question and one for which we’ve never received a straight answer.  In the past we’ve criticized FDA about their handling of drug safety data.  And in their defense, things have generally gotten better over the past couple of years.

That said, the continuing delay in releasing vital – and valuable – drug safety data is still an area of deep concern.  For every day that data is not released, there are more prescriptions being written – and more patients being potentially put at undue risk. How many patients on Viekira Pak could have avoided unnecessary side effects if their prescribers and managed care companies had had the comparison safety data in hand, and how much money would have been saved by avoidable medical appointments, etc?

We continue to urge FDA to make progress in releasing all of the FAERS data as quickly as possible.  But until then we’ll continue our program selectively pursuing up-to-date data through the FOIA program.

To see how Advera Health clients got an early warning on Viekira Pak, download the Drug Safety Monitor report, Chronic Hepatitis C: New FOIA Data Reveal Viekira Pak Riskier than Harvoni.

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Topics: FDA, FAERS

Brian Overstreet

Written by Brian Overstreet