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Petition Argues FDA Has Overstepped In PGx Regulation

 
• By Elizabeth Orr

A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness – an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.

Target

Recent efforts by the US Food and Drug Administration to regulate a type of personalized medicine are “unprecedented and unlawful,” a coalition of manufacturers and clinicians claim in a recent Citizen’s Petition.

Law firm Hyman, Phelps & McNamara filed the 9 January petition with the FDA on behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx). In it, the group argues...

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