The Back and Forth on Safety Versus Speed and FDA

This week the Commissioner issued a statement related to the proposed modernization of the FDA’s drug review office, also the subject of a blog post by FDA’s head of the Center for Drug Evaluation and Research Janet Woodcock. While focused on the drug review process, they are just the latest pronouncements from the agency to address move to speed up the approval processes for all things – devices, digital health, artificial intelligence interventions, not just drugs.  And with the passage and enactment of the 21st Century Cures Act among other things, there has been policy momentum to change the status quo. The word “modernize” has become code for reducing regulatory process – or sometimes in political parlance “reducing regulatory burden” without compromising safety or the “gold standard of the agency”.  

There are a lot of good reasons to speed things up and to maximize access to new treatments. As Dr. Woodcock noted in her blog posting, the environment is dynamic – things change  – evolving technologies, the emergence of new kinds of therapies – and the way we evaluating them has to change with it. 

The need for changes in the system of approvals was very apparent in the earliest years of the AIDS epidemic when there were no treatments available to patients other than those used to address the opportunistic infections that came about as a result of a compromised immune system – and even those treatments were often without much impact.  The average length of time that it took for a drug approval was much longer than it is today. According to a table developed by the General Accounting Office, in 1987 the average length of time from submission to approval for a new drug was at its longest – 33 months. By 1992 it was 18 months. In short the need was extreme, the ability of the system to deliver was not. 

Though the wheels of progress moved slowly,  as a result of AIDS activism, eventually changes came about that resulted in formalized mechanisms that had been under consideration to expedite drug approvals.  The result were several new mechanisms introduced over a period of years designed to facilitate approval as part of the FDA review process – Priority Review, Fast Track, and Accelerated Approval.   And the most recent pathway for expediting approval came in 2012 with the Breakthrough Therapy Designation.

But speeding approvals were also sometimes associated with at least a perceived sacrifice in safety. In the early 2000s there emerged a public debate about the impact of these programs when several high profile drugs were associated with serious side effects, some of which were eventually withdrawn from the market. Several drugs that had been Fast Tracked were withdrawn either for lack of efficacy or safety reasons such as hepatoxicity and cardiovascular events. 

We are now on the cusp of a good deal of change that is poised to pick up the pace broadly. 

As we approach a new level of a systemic easing the regulatory burden – one that goes beyond what was accomplished in the past in that regard- often coupled with reassurances that FDA’s gold standard will not be compromised – we have to be aware that getting the pendulum in exactly the right spot is likely impossible.  Most of the focus so far has been on the steps being taken to speed up and facilitate the process of approval. But in doing so, we have to also ensure that our methods for evaluating that whether the “gold standard” is being maintained are also modernized so that we keep up with monitoring the effects of so much change.   

Photo by Ben Ostrowsky on Unsplash

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