In an unsurprising case of duh! federal investigators from the Government Accountability Office (GAO) came to the conclusion that the FDA is not doing well at one of its main responsibilities. The FDA is failing to properly track drugs after they hit the market. The GAO, Congress nonpartisan investigative department, discovered problems.
According to the GAO report, FDAs data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult.
Rep. Rosa DeLauro (D-CT) ordered the GAO investigation. She wanted to check the FDAs record on tracking drug problems given the ever-increasing amount of new drugs that are being fast-tracked through the FDAs approval process. While Rep. DeLauros concern is well placed, one wonders how far it goes.
Rep. DeLauro was one of the original sponsors of Rep. Mike Fitzpatricks (R-PA) E-Free Act, a bill designed to strip Bayers Essure device of its PMA approval status, thus allowing injured patients legal recourse. It would also take Essure off the market. Then, with seemingly no reason or warning, Rep. DeLauro pulled her support of the bill. Critics of her move cite possible donations from Big Pharma as a reason, but no official reason was given, that I have been able to find.
It is certainly a hopeful sign that she is the one behind the GAO audit of the FDAs ability to track drugs post-market. Perhaps this is a signal that she had other reasons for pulling support of the E-Free Act.
The investigation itself covered drugs approved by the FDA from October 2006 to December 2014. It revealed that of those drugs, roughly 25% were approved via one of the agencys fast-track programs.
Those programs have many vocal critics and rightly so. The criticism is that the programs give drug makers far too much freedom to delay the release of longer-term evidence of a drugs safety and efficacy until its already being sold and used. This, critics say, opens innocent patients up to unnecessary risk. The GAO report doesnt do much to dispel the critics concerns. If anything, it provides proof that the system is broken.
The president of the nonprofit consumer research group, the National Center for Health Research, Diana Zuckerman said, We are shortcutting an important part of the approval process in the hope that we get the information later, but now were finding out thats not happening.
Dr. Zuckerman is absolutely correct and the GAO report proves it.
Proponents of the fast-track programs insist they are necessary for the betterment of patient care. They claim that instead of increasing risk, the programs are getting much needed to serve smaller patient populations as well as larger ones in a more expeditious manner. In fact, the more than likely to be Senate confirmed next head of the FDA, Dr. Robert Califf, is in favor of even faster fast-track programs.
That thought alone is enough to send shudders down ones spine.
For its part, the FDA claims to have investigated some of the very same issues over the last few years and its response was part of the GAO report. And guess what? The GAO investigators were less than impressed.
Their findings, which cited the agencys response, indicated that the majority of FDA-identified potential safety issues were not being tracked in the agencys drug safety database. The FDA response was that a policy change had made entering that data more difficult. The agency also said that roughly two-thirds fewer issues were being entered by FDA staffers than were being entered before the policy change. The FDA response also said that the computer system itself was cumbersome and didnt allow issues to be sorted by FDA action, patient population or disease type.
Really? A policy change and a bad computer system were not fixable?
More frightening was investigators findings that there was a backlog in the review process of reports issued by drug makers regarding progress on their post-market studies. The backlog, covering close to 1,400 studies over five years, included over half of all reviews.
Clearly, the system needs some work.
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