The FDA Looks Into Re-Labeling Opiates to Keep Them From Being Overprescribed
Doctors, drug companies, and the FDA discuss ways to help the opiate epidemic in the US, with the suggestion of re-labeling these medications so they could not be overprescribed.
Doctors, patients, and advocacy groups urge federal officials to make it illegal for drug companies to market prescription opioids to treat chronic, long-term pain. According to JSOnline.com, this would help to curb the increase in overdoses and addiction that has been caused by these powerful opiates. The opposition argues that this will mean people who desperately need these medicines will not have access to them.
The Journal Sentinel claims that these opiates have been increasingly prescribed for pain, in areas where their safety has not yet been proven, especially with older patients. The pharmaceutical industry has flexed its financial influence, by offering doctors and researchers kick-backs for expanding the use of opiates. This information prompted a US Senate investigation into the finical ties between drug makers and doctors.
The US Food and Drug Administration was part of a two-day meeting to discuss the effectiveness of treating chronic pain with opiates. Douglas Throckmorton, the FDA's deputy director of the Center for Drug Evaluation and Research said, "We need to start with science. We know less than we would like about chronic, non-cancer pain." Opioids are approved for moderate to severe pain, but that labeling does not specify whether they are safe to use for long periods of time.
Long-term studies on chronic pain and opioid use have not been done, and opiates were approved decades ago when the standards for drug approval were less stringent. Determining what a drug can be approved to treat affects how products can be marketed, as pharmaceutical companies are only allowed to market their drugs in areas approved by the FDA.
Doctors will often prescribe "off-label" drugs to treat conditions for which the drug was not approved. But, advocates believe that by making it clear that opiates have not been proven safe and effective for treating chronic pain will limit the prescribing of these opioids. Others worry that limiting these prescribing ability for opiates will deny some people the medicine they need to live, as well as not being able to get this medication through their insurance.
Throckmorton admits that more evidence is needed before these changes could be made. He said, "FDA can't solve this alone. Academics can't solve this alone. Patient groups can't solve this alone. We need to be doing a great many things and not a single thing."
Opioid makers, of course, opposed changing the labeling of their product. A spokesperson for Purdue Pharmaceuticals said, "The current approved label for Oxycontin is appropriate as it accurately reflects the patient population studied in multiple clinical investigations. These studies evaluated patients suffering from chronic moderate-to-severe cancer or non-cancer pain." Purdue also claims that the under-treatment of pain is a public health burden. They said, "When used as directed, opioid pain medicines are an important treatment option for health care professionals, and provide therapeutic benefit to millions of people living with chronic pain. While opioids are often used in combination with other therapies, for many people with moderate-to-severe chronic pain, there is no single adequate medical substitute for opioids."
Some doctors argue that the opioid epidemic is a direct result of the liberalized use of these drugs to treat pain, stating that prescriptions for opiates have quadrupled in the last decade. These doctors beg for better prescription drug monitoring programs, tracking prescriptions and helping doctors to identify drug-seeking behaviors.
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