Nick Johns

Our current administration has made it clear that when it comes to approving new drugs, the plan is to prioritize speed in order to dismantle monopolies. More drugs approved to safely treat the same condition leads to market competition and, hopefully, lower prices for everyone. This may sound like a solid approach, but it’s worth taking a step back to examine our current system and determine if it’s really as slow as the Trump administration is making it out to be.

Over the past several decades, the FDA drug approval process has undergone some fairly drastic changes. Starting in the late 90s, four programs have been introduced to provide accelerated avenues for development and approval of drugs which may provide a breakthrough improvement over current treatments, or for which medical need is substantial. One clear benefit of a shorter development timeline is the potential to more quickly deliver new treatments to patients in need. In the 1990s, the FDA’s “fast track” processing provided an edge in the battle against HIV/AIDS. The need was dire, and many of the drugs developed through the fast track program are still widely used to treat HIV infection today.

On the other hand, shorter time frames mean smaller windows for clinical trials and testing for adverse effects. With four separate fast lanes providing expedited review, 222 new drugs were approved between 2001 and 2010. 71 (32%) of those drugs were eventually withdrawn, required a "black box" warning, or warranted a safety announcement about new risks discovered post-approval. An example of the risks posed by a more lenient approval process can be found in the anticoagulant Pradaxa. Pradaxa was awarded fast-track status due to the justification that it was safer alternative to Warfarin and that patients would therefore require less monitoring. It was approved within six months, in Oct. of 2010.

Postmarket surveillance found an increased risk of gastrointestinal bleeding among patients taking Pradaxa, and a safety alert was announced in May of 2014. Unlike Warfarin, for which vitamin K could be used to reverse its anticoagulation effect in the case of a serious bleeding event, Pradaxa was approved and used without an antidote for five years. In that time, the FDA has reviewed thousands of deaths attributed to Pradaxa.

In a climate where medical expenses are the top cause of personal bankruptcy, a faster approval process with more lenient trials doesn’t seem to be the right direction as far as patient safety is concerned. Critics of the approach have cited other ways to reduce drug costs, since loosening regulations and cutting corners on testing in a system already releasing substances with potentially life-threatening side effects to the public is a slippery slope.

Moving forward, it’s more important than ever to take extra time to discuss with our doctors the potential side effects and interactions of drugs prescribed to us, as well as why specific medications were chosen. While we wait for our administration to find a solution to rising drug and healthcare costs, people should utilize available tools such as to compare drug prices online. We won’t be able to fix our healthcare system without exploring every option available to us, and we can set an example by taking matters into our own hands.


Nick Johns is a content writer from New York who combines his easily-piqued curiosity with a passion for research. Nick has covered a number of topics, with a focus on healthcare and consumer security.

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