FDA Proud of Post Approval Drug Safety Enforcement Efforts

Posted on April 23, 2012

The Food and Drug Administration is touting its ability to police drugs even after they’ve been approved.

On Saturday, the organization said that the same amount of resources are spent making sure that existing drugs are safe as are spent in the pre-approval stage of a drug’s life.  The statement came following critics’ remarks that the FDA isn’t protecting consumers from drugs already on the market.  The FDA has said that 385 post-market studies have been launched since 2008, and in that time, the studies have forced companies to change their product’s labels in 65 instances.

Until 2008, drug makers only had to voluntarily institute label changes if requested by the FDA.  But there was a change in tide when Congress gave the FDA the ability to institute fines and order label changes on drugs that had already been brought to market.  These new powers came two years after the Institute of Medicine released a report suggesting that the FDA could do more to promote product safety post-approval.

2008 was also the year that the FDA launched a program called Sentinel.  This program uses computers to track side effects through a number of databases, discovering problems without having to rely on a patient or a company making a report.

As a personal injury attorney in Riverside, I’m glad to see more efforts being made to keep consumers safe from already existing products.  It’s always possible that time can prove an item to be unhealthy.  New drugs can certainly be hazardous, but as a Ventura personal injury lawyer, I know that existing products can also pose a threat in certain circumstances.

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