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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Will the FDA Finally Get Subpoena Power & Recall Authority?

Posted in FDA Regulation, Politics

Did you know that the FDA doesn’t have subpoena power? That’s the power to make a company hand over a document.  Every single attorney in the U.S. can subpoena a document from a pharmaceutical company, but the FDA (which is supposed to regulate pharmaceuticals) doesn’t have that power. 

Citing a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation’s drug supply.

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Bennet’s proposal would update FDA data systems to track all global manufacturers feeding America’s drug supply; force companies to document each contributor to their products; grant FDA subpoena authority when conducting investigations; and empower FDA officials to recall drugs when safety issues arise — a power the agency currently has over medical device makers, but not the pharmaceutical industry.

Supporters of the proposal are armed with a slew of statistics backing their case. Last year, for instance, the country saw a record 1,742 drug recalls, they note — a 400 percent jump over 2008. More than 100 Americans, they add, died in 2007 and 2008 from the Chinese-made blood thinner heparin. 

Source: Senate bill would bolster drug safety requirements – The Hill’s Healthwatch

I hope that this bill gets passed so the FDA has the tools it needs to do its job.