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When you’re desperately ill, your chances of relief and recovery improve as your access to treatment improves. That’s why it’s such good news that the Food and Drug Administration (FDA) is working to speed up the process of getting new medications to patients.
The FDA has two critical missions. One is to ensure that medications approved for sale to patients are safe and effective. The other is to get effective treatments to patients as quickly as possible.
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Unfortunately, the two missions can come into conflict. Here’s the dilemma: Approve a drug too quickly without a comprehensive review of safety and efficacy, and the example that haunts all regulators might come to pass yet again. That would be the thalidomide tragedy of the 1950s when a treatment for morning sickness in Great Britain in pregnant women led to severe birth defects.
But taking too long to approve a safe and effective treatment also takes a toll: patients who could benefit from the new treatment don’t get it in a timely fashion, sometimes with fatal consequences.
Nobody - Regulator - Medicine - Approval - Imposes
Nobody wants to be the regulator who approves a dangerous medicine, whereas delayed approval imposes costs visible to very few. Regulators, therefore, have an incentive to err on the side of more testing and delay.
The FDA has long been aware of this problem. The agency has looked for and found steps to take to streamline approvals where safety reviews have shown positive results. And they are starting to pay off.
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In 2017, the FDA approved more than 1,000 generic drugs — 200 more than had ever been approved in a single year previously. It also approved 46 novel drugs — more than twice as many as it did in 2016.
Not only are patients getting faster access to treatments. In addition, the increase in the number of different treatments on the market...
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