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Are Faster FDA Approvals the Answer? By Our March Student Pharmacist, Deanna Clause.


In President Trump’s first speech to Congress, he criticized the Food and Drug Administration for having a “slow and burdensome” approval process. He gave an example of how this slow approval process had prevented a young woman with a rare genetic disease from receiving optimal treatment. He stated that he would “slash the restraints, not just at the FDA, but across the government.”

To provide some background on the drug approval process, there are multiple steps in place to ensure drugs meet necessary safety and efficacy measures. The timeline for approval starts with pre-clinical trials to determine appropriate dosing and toxicity before testing in humans. Appropriate applications and approvals of study designs/protocols are needed before initiating clinical trials in humans, which are performed to confirm proper safety and efficacy with increasing numbers of human subjects with each phase. This entire process could potentially take several years, with some instances taking up to 15 years.

Over recent years, the FDA actually showed improved and faster approvals. According to FDA figures, the median review time for approvals was 10.1 months in 2016. This is a marked improvement from 27 months in 1993. The agency even has expedited the approval process for drugs that are meeting an unmet medical need or show exceptional promise. President Trump seems to be misguided on his belief about the slowness of the approvals, as many current agency officials state that they are actually getting criticized for pushing prescription products through too quickly.

One view that seems to capture the true issue today is from Vinay Prasad, an oncologist and assistant professor of medicine at the Oregon Health and Sciences University. He states, “Republicans are obsessed with the idea that the FDA is a barrier to wonderful drugs reaching the market, but that isn’t true; the barrier is that making wonderful drugs is scientifically difficult.”

For example, some cancer drugs that have faster approvals may only improve survival by a few months while costing the patient thousands of dollars. Also, some products that are just as expensive may not even improve survival, but just add to improved quality of life. The patient may be suffering from a terminal illness, but the benefits of some of these drugs may not outweigh the costs.

This topic highlights current unrealistic expectations that a drug is the answer to everything and that we have unlimited resources to pay for these drugs. This complex issue seems to require an alternative approach in place of loosening FDA regulations.

To find out more, keep up to date with the FDA on Facebook HERE.


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