Center Warns of Unintended Consequences of Proposed FDA Pain Policy

May 29, 2009

The Center for Practical Bioethics is concerned, like many others, about the dramatic increase in the misuse of prescription drugs. At the same time, the Center is asking the Food and Drug Administration for a balanced approach in developing strategies to curb misuse of opioid painkillers.

That’s according to a statement delivered by John Carney, vice president for aging and end of life at the Center for Practical Bioethics, during an FDA public hearing to consider a Risk Evaluation and Mitigation Strategy (REMS) for the use of opioids.

The FDA's Center for Drug Evaluation and Research conducted the two day public hearing in Gaithersburg, Maryland, on May 27 and 28 to gather input on what factors to consider in drafting the strategy.

Links:

News Release, May 29

Center statement, The Ethics of Pain: Unintended Consequences and Vulnerable Populations, May 28

Seeking a Balanced Pain Policy, Center video, 7 minutes 38 seconds

New Policy Brief aims for Balance in Pain Investigations, Center podcast, The Bioethics Channel featuring Bill Colby, 14 minutes 15 seconds

Increased Scrutiny of Opioids Could Alter Prescribing Practice, MedPage Today, May 28

Docs Urge FDA to Go Easy on Opioid Risk Reduction Strategies, MedPage Today, May 27