Concerns Over Opioid Painkiller Abuse To Be Subject of FDA Hearing

The FDA plans to hold a public hearing concerning the use of opioid drugs to treat chronic pain beginning February 7, 2013, according to information released by the Office of the Federal Register.  

Due to numerous comments, petitions and informal inquiries surrounding the use of narcotic pain medications that have been submitted to the FDA in recent years, the agency is asking for information and presentations of scientific data concerning the drugs. The two-day hearing will also address the rising use of opioid drugs for chronic pain treatment.

In particular, officials will undertake topics such as the diagnosis and understanding of patient pain and issues such as the methods professionals use to distinguish various types of pain and focusing on a definition for terms such as mild, moderate or severe in diagnosis.

Other specific drug concerns, such as product composition and abuse deterrence, remain at the forefront of the discussion.

Concerns regarding the broad class of drugs, like drug dosage controls, prescribing practices and the duration of administration of the drugs will also be explored during the hearing.

Opioid drugs are already under heavy scrutiny due to the high level of abuse. Many of the popular drugs such as Vicodin, Norco, Oxycontin and Methadone are offered in a pill form which allows users to grind them up and snort the power, much like heroin.

Opioid drugs are subject to the Risk Evaluation and Mitigation Strategies (REMS) policy, a system which is typically used when a drug is considered too dangerous. Officials hope to find balance in minimizing drug abuse while also allowing access to such drugs to patients who need the medication for treatment. While experts feel the benefits often outweigh the risks, better controls and limiting abuse remain key topics.

The announcement of the hearing comes shortly after an FDA review board voted not to approve a new single ingredient opioid drug, Zohydro, citing the high risk of abuse as the primary concern. The FDA is not required to follow the committee’s recommendation, but often does. They are expected to make a final decision regarding the approval by March.

The public hearing is scheduled for Feb. 7 and 8 at the Bethesda Marriott in Bethesda, Maryland. Attendees who wish to make oral presentations, submit electronic comments or written requests are directed to http://www/regulations.gov. The deadline for oral presentations is  Jan. 18, 2013 and the deadline for written or electronic communications is April 8.