FDA Wants Detailed Industry Plans on Preventing Abuse of Opioids

The U.S. Food and Drug Administration (FDA) is holding a series of meetings with pharmaceutical companies as the industry crafts a plan to help prevent misuse of opioid-based medications, Reuters reported Dec. 4.

Regulators met with industry representatives last week to get more details on the risk-evaluation and mitigation (REMS) plan that the FDA requested earlier this year. Company officials said they were developing a voluntary training program to educate doctors about proper practices and government certification for prescribing drugs like methadone and oxycodone.

Some experts expressed concern that doctors might choose not to prescribe the drugs if regulation is increased; an FDA official said the agency is looking to balance the need to reduce abuse with the need to make effective painkillers available to patients. More meetings on the plan will be held next year.

The National Center on Addiction and Substance Abuse (CASA*) at Columbia University petitioned the FDA in May 2009 for a REMS plan that covers the entire class of opiate-based medications and would include education for both patients and doctors as well as “elements to assure safe use,” such as certification of prescribing physicians.

CASA also requested that “each opioid drug risk evaluation and mitigation strategy … include a certification that the drug has been formulated to minimize potential for abuse, both intentional and unintentional, to the extent possible without compromising the drug’s therapeutic effectiveness.”

*The National Center on Addiction and Substance Abuse at Columbia University is neither affiliated with, nor sponsored by, the National Court Appointed Special Advocate Association (also known as “CASA”) or any of its member organizations with the name of “CASA.”