Streamline drug approval process

Streamline drug approval process
When you're desperately ill, your chances of recovery improve as your access to treatment improves. That's why it's such good news that the Food and Drug Administration 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 treatments to patients as quickly as possible.

Unfortunately, the two missions can come into conflict.

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.

 
Sign Up for Our Email Newsletter

RECENT NEWS

Restoring the Balance Between Innovation and Generic Manufacturing of Medicines

Restoring the Balance Between Innovation and Generic Manufacturing of Medicines

Closing the patent challenge loophole is essential to restoring the balance between innovation and imitation. ...  Read more

How ‘Right to Try’ Laws Fail Patients Who Need Experimental Medicine

How ‘Right to Try’ Laws Fail Patients Who Need Experimental Medicine

The debate over access to experimental medicines must continue to evolve from Right to Try to the right way to try....  Read more

A front for government price controls

A front for government price controls

Let’s hope the measure doesn’t gain steam. Binding arbitration — essentially government price controls — would be catastr...  Read more

DRUGWONKS BLOG