9/3/15 FDA & First Amendment


A judge’€™s ruling last month was a victory for the First Amendment.  

A federal judge struck down FDA action against small drug maker, Amarin.  

The issue is off-label marketing of approved drugs.  If a drug receives FDA approval to treat one ailment, and later research shows it can also treat another ailment, drug makers have marketed the drug to treat that second ailment. 

The FDA has argued that making true claims of an approved drug constitutes a criminal act if the agency hasn’t approved the new marketing claims.  

To require drug makers to again go through the lengthy, costly and time-consuming approval process slows down innovation and contributes to rising medical costs.

In an similar case, a pharmaceutical sales rep was criminally convicted of misbranding a drug.  He merely referred doctors to medical literature that described additional uses of an approved drug.  The court of appeals overturned his earlier conviction. It ruled the FDA could not prohibit him from making true statements.

Last month, Judge Paul Engelmayer ruled that Amarin may market its fish-oil drug for other uses as long as its claims are truthful.

This First Amendment victory also slows the FDA’€™s attempt to expand its control over the medical industry.

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