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Rapid Drug Approval Linked to Safety Issues

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Mary Wolff3 years ago

According to Medscape, the US Food and Drug Administration (FDA) has increased the approval process for new drugs since 1992.  Some are suggesting that the FDA speeding up the process may have created more harm than good.  

Is Faster Always Better

The FDA accelerating the approval process for new pharmaceuticals has created a never ending cycle of drugs being removed from the market and new drugs being introduced to replace them. The new drugs are eventually replaced by even newer medicine and this perpetuates the cycle further.  

Since 1992, there has been an increased number of black box warnings and drugs being withdrawn from the market as a result of the increased speed at which they approve new drugs.

A black box warning on a prescription medicine is the warning of all the worst case scenario side effects of using that particular drug.  It is essentially the safety measure for the FDA to allow a drug to be sold to the public.

In addition to black box warnings increasing in the twenty years, the number of drugs being pulled off the market entirely has skyrocketed.

The Rush and the Ramifications

In 1992, the Prescription Drug User Fee Act (PDUFA) was enacted. The act allowed the FDA to benefit financially by collecting fees from pharmaceutical companies to pay for resources necessary to accelerate the drug-approval process.

Since 1992, PDUFA has been renewed four times. However, there is concern amongst some that drugs may not have been given enough time and testing, due to the FDA wanting to rush the drugs through approval process.

This notion would explain why so many drugs get taken off the market or receive such serious black box warnings and, yet, are still offered to the public. The FDA claims the sped up process has no connection on the safety value of the drugs and to have high standards and the public’s best interest at heart.

Healthcare professionals are encouraged to use older and therefore more stable drugs before jumping on board with newer drugs, unless those drugs are granted breakthrough status – meaning there is significant evidence that the drug can greatly benefit a patient diagnosed with a serious, potentially deadly diseas.

Doctors should always use their best judgment in prescribing drugs to patients.


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