gao.pngRecently a report by the U.S. Government Accountability Office (GAO), filed at the request of Representative Rosa DeLauro on December 15, 2015 was made public. The report’s focus was to better understand the rate at which drug applications were expedited using “fast track” and “breakthrough therapy” designations and if FDA was fulfilling its duty to properly track and analyze post-marketing monitoring for those drugs.

The answer was no. The FDA is not fulfilling its duty to the American public in regards to drug safety. The overall conclusion among GAO investigators put simply was:

“FDA lacks reliable, readily accessible data on tracked safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities and to conduct systematic oversight”

The GAO investigators found that sponsors submitted more than 770 fast track designation requests since 2007, with FDA approving two-thirds of the requests. Sponsors submitted more than 220 requests for breakthrough therapy designation with FDA approving less than half. The issues GAO found centered on drugs identified as “ones to watch” and FDA’s lack of monitoring. FDA hasn’t posted a new quarterly report to their “Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)” site since December 2014. They also found the database had inaccurate and incomplete data, and the data were not readily accessible in a form that the staff could use for analysis.

A STAT News article on the GAO report noted that a data backlog for post-market studies that have been submitted, but not reviewed by FDA staff, has been a recurring problem. In addition to the roughly 1,400 study backlog that GAO found in this review, back in 2008 a contractor hired by FDA found that more than 500 post-market studies had been submitted, but not reviewed.

So, in summary:

  • FDA is approving more drugs faster than ever before.
  • FDA is well behind in monitoring drug safety risks that they themselves have identified as concerns.
  • FDA is not reviewing post-market data that they themselves have requested from manufacturers, as a result of safety issues.

The GAO report confirms that FDA is failing when it comes to drug safety.

If you are reading this, or any other commentary on the subject, you as one of the seven in ten Americans that take a prescription drug, should be scared as hell. Or if you are lucky enough to be in the minority and not have to rely on a prescription medication policed by an underserving FDA, you should be at least furious at the massive economic burden that FDA’s failure puts on the healthcare system. Advera Health research estimates that drug safety issues cost the system about $25 billion every year.

With expedited approvals and rising costs, the ship has set its course, and there is no one at the helm. Our healthcare system relies heavily on FDA when it comes to drug safety. It has long been Advera Health’s contention that this reliance is not prudent. That other stakeholders within the system need to take control of their own surveillance and evidence gathering in order to make the best decisions possible. This GAO report is proof that our contention is indeed correct.

How then can other stakeholders, who certainly don’t have $701 million to spend on drug safety initiatives like CDER/CBER, possibly take control? The answer is they don’t have to. The beauty of capitalism is that when there is a problem this massive that cannot be fixed by government spending, or even reform, private enterprise can step in and create solutions.

At Advera Health we have already begun to work with various stakeholders across the healthcare ecosystem to make better decisions before FDA, by making FDAs own data actionable. Formulary Committees are using FDAs data and our analytics to better understand the full drug safety picture. Tracking safety signals? No need to wait for FDA to update their database. VP’s of Pharmacy at managed care organizations are using FDAs data and our analytics to understand the impact those safety signals could have on a managed care organizations bottom line. No need to wait for a drug’s label to be updated. Hospitals are incorporating FDAs data and our analytics into their ADR call centers, allowing attending physicians and clinical pharmacists to quickly understand if a condition is one that is drug induced. FDA doesn’t have to issue a warning.

Representative DeLauro said in a statement:

“The GAO report confirms my greatest fear, that FDA lacks fundamental resources and leadership in ensuring that drugs brought quickly to market are truly safe and effective,” … “If FDA is shifting more of the safety risk to consumers by allowing fewer and shorter clinical trials on expedited drugs, adequate tracking of drug safety issues and review of post market studies are absolutely vital.”

We could not agree more. In 2016 we intend to continue picking up where the FDA leaves off, innovating specifically in the area of evidence review and analysis.

Learn more about the FDA Adverse Event Reporting System with our comprehensive guide to FAERS


Jim Davis, EVP


Topics: Drug Safety, FDA

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.