FDA Urges Drug Companies to Focus on Abuse Potential

New voluntary guidelines issued by the U.S. Food and Drug Administration (FDA) direct pharmaceutical companies to more closely examine the abuse potential of new drugs and help determine if and how they should be listed under the Controlled Substances Act, the Baltimore Sun reported Jan. 27.

The FDA guidance says that drugmakers should look beyond addictiveness to also consider other ways that drugs could be abused. Michael Klein, director of FDA’s controlled substances program, noted that the anesthetic propofol — one of the drugs that killed pop star Michael Jackson — is not a controlled substance but has reported abuse potential.

“They’re expanding this idea that abusable drugs aren’t just the ones that are addictive,” said Scott Fishman, chief of pain medicine at the University of California at Davis’ School of Medicine.

FDA is currently gathering public comments on the proposed guidance (PDF). 

Leave a Reply

Please read our comment policy and guidelines before you submit a comment. Your email address will not be published. Thank you for visiting Join Together.

Required fields are marked *


*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

FDA Urges Drug Companies to Focus on Abuse Potential

New voluntary guidelines issued by the U.S. Food and Drug Administration (FDA) direct pharmaceutical companies to more closely examine the abuse potential of new drugs and help determine if and how they should be listed under the Controlled Substances Act, the Baltimore Sun reported Jan. 27.


The FDA guidance says that drugmakers should look beyond addictiveness to also consider other ways that drugs could be abused. Michael Klein, director of FDA's controlled substances program, noted that the anesthetic propofol — one of the drugs that killed pop star Michael Jackson — is not a controlled substance but has reported abuse potential.


“They're expanding this idea that abusable drugs aren't just the ones that are addictive,” said Scott Fishman, chief of pain medicine at the University of California at Davis' School of Medicine.


FDA is currently gathering public comments on the proposed guidance (PDF). 

Leave a Reply

Please read our comment policy and guidelines before you submit a comment. Your email address will not be published. Thank you for visiting Join Together.

Required fields are marked *


*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>