Panel Turns Down FDA Proposal To Control Prescription Narcotic Painkillers

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Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry;  Primary Care / General Practice
Article Date: 25 Jul 2010 - 12:00 PDT

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An FDA (Food and Drug Administration), USA Advisory Committee voted 25 to 10 against a proposal to reduce the abuse and misuse of long-acting narcotic painkillers, such as OxyContin or Vicodin. Although the Advisory Committee's recommendations are not binding the FDA usually follows them when making a regulatory decision.

The Committee's main reason for turning the proposal down, they say, was because it did not insist that doctors undergo training in the proper use of long-acting narcotics.

There is a surging dilemma among US health care professionals and patients seeking therapies for pain. Prescription narcotics are extremely effective in alleviating pain symptoms, but they have also been linked to a USA-wide explosion in prescription medication abuse and dependency (addiction). The number of deaths linked to overdosing on these medications are counted in the thousands annually.

In 2008 the pharmaceutical industry, together with the FDA started working on a scheme aimed at reducing misuse and abuse of long-lasting narcotic drugs. Several public meetings have taken place, in which experts, patients, health authorities and advocacy groups discussed the details of a potential drug misuse and abuse plan.

At first, FDA officials appeared to propose the compulsory training of doctors regarding long-lasting narcotic medications. This proposal eventually became a provision that urges physicians to undergo training on a voluntary basis, which the pharmaceutical industry would organize and run. Many experts said such a proposal lacked teeth; a comment the Advisory Committee appears to have echoed.

The Advisory Committee was not happy about the voluntary aspect of the proposal.

Some in the FDA believe that if compulsory training were required, some physicians might decide simply to exclude those drugs when prescribing, and in that way bypass training.

For a doctor in the USA to currently be authorized to prescribe narcotic painkillers, they simply register with the DEA (Drug Enforcement Agency). To bring in legislation that required mandatory training before being registered with the DEA requires Congressional approval.

Millions of Americans with significant or chronic pain associated with their medical problems are being under-treated as physicians increasingly fail to provide comprehensive pain treatment - either due to inadequate training, personal biases or fear of prescription drug abuse, a new study revealed.

According to Medilexicon's medical dictionary:

A narcotic is Originally, any drug derived from opium or opiumlike compounds with potent analgesic effects associated with both significant alteration of mood and behavior and with potential for dependence and tolerance.

More recently, any drug, synthetic or naturally occurring, with effects similar to those of opium and opium derivatives, including meperidine, fentanyl, and their derivatives.

Capable of inducing a state of stuporous analgesia.

Written by Christian Nordqvist


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