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FDA Requires New Labeling for Some Opioids

Modest Changes Walk Narrow Political Line
Stephen Barlas

The FDA’s revised labeling requirements for some opioid analgesics fall far short of what some advocates of upgrading had wanted. On September 10, 2012, the FDA announced its response to a petition submitted in July 2012 by a support group, Physicians for Responsible Opioid Prescribing (PROP). Composed of leading academics in the fields of pain control, psychiatry, and other medical disciplines, the group asked the FDA to prohibit opioids from being labeled as approved for “moderate” non-cancer pain, to add a maximum daily dose, and to add a maximum duration of 90 days for continuous (daily) use for non-cancer pain.

The FDA declined to limit its changes to non-cancer pain or to include immediate-release (IR) products. The agency did not institute a maximum daily dose for opioids or specify a limit on duration of therapy.

The agency stipulated that the new labeling, required by May 2014, should say extended-release/long-acting (ER/LA) opioids are indicated for patients whose pain is “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments to manage the pain are inadequate.” The new language for ER/LA opioids identifies potential alternative treatments such as non-opioid analgesics and IR opioids and provides some guidance for when those alternatives may be insufficient to relieve pain. By comparison, the current labeling specifies that these drugs are indicated for moderate-to-severe pain when a continuous, around-the clock analgesic is needed for an extended period of time.

Andrew Kolodny, President of PROP and Chief Medical Officer of the National Phoenix House Foundation, a national not-for-profit addiction treatment agency, says the FDA acceded to about 10% of what PROP had requested. He argues that the new labeling language “sounds like something a drug company lawyer might write.” However, FDA Commissioner Margaret A. Hamburg said that in ordering the change, the agency had to recognize the medical value of opioid analgesics for many patients living with pain.

Opioid addiction has become a major national health concern (as previously addressed in P&T).1 An analysis published by the Centers for Disease Control and Prevention (CDC) in February 2013 documented increases in drug-overdose deaths for the 11th straight year. Opioids were involved in 75% of those deaths, either alone or in combination with other drugs.

The FDA’s previous attempt to stem this tide was its requirement for a Risk Evaluation and Mitigation Strategy (REMS) for ER/LA opioid analgesics in July 2012. More than 30 products are subject to that REMS, which contains requirements for distributing a medication guide to patients with each prescription they fill and for training to be made available to all those who prescribe ER/LA opioids.

PROP argued that drug companies preferred the current fungible FDA-approved label because it allows them to encourage the use of opioids for an indefinite period of time and for various common problems such as back pain and fibromyalgia. If the FDA had approved the gamut of PROP changes, that might have crimped the availability of prescriptions for questionable uses—not because physicians couldn’t write those scripts but because the drug companies would have had to stop marketing those opioids as “off label” for long-term and non-cancer treatment.

Yet even though the list of changes sought by PROP would not have tied physicians’ hands, the broader medical community—particularly groups representing pain doctors—strongly opposed new limits on labeling. The American Academy of Pain Medicine (AAPM) argued against eliminating the reference to “moderate” pain on product labels, but the FDA rejected that request, too, as well as some of PROP’s entreaties, perhaps as a way to even out the score. The new labeling does not mention moderate pain.

The FDA also wants to require drug companies to conduct more clinical trials to further assess the risks of opioid pain drugs. Specifically, agency officials want to determine whether using opioids at certain dosages or for a certain duration is more likely to trigger an addiction. The agency also will require a new boxed warning for this drug class, cautioning that chronic use during pregnancy could result in neonatal opioid withdrawal syndrome, a life-threatening condition.

One area that both the current and new labeling ignores is the larger role that pharmacists might play in reducing the improper use of opioids. Here, too, the FDA is perhaps a bit circumscribed, politically, as to how much leverage it can give pharmacists. The American Medical Association has strongly opposed the FDA’s consideration of a new over-the-counter (OTC)-plus category, which would consist of some categories of drugs for which prescriptions are currently needed. The AMA fears that the new category would strengthen the role of pharmacists and diminish the role of physicians. For example, as consumers seek drug information, pharmacists might eventually be permitted to prescribe medications.

Some pharmaceutical companies, however, are encouraging pharmacists to ask questions. Walgreens adopted new guidelines that urge pharmacists to ensure that each opioid prescription filled has a legitimate medical purpose. Part of that process may call for pharmacists to exercise their professional judgment in verifying diagnoses or treatment plans.

The notion that pharmacists might call doctors to check on prescriptions has enraged some physician groups and their members. But physicians, just like everybody else, also need double-checks.

  • Barlas S. Prescription drug abuse hits hospitals hard: Tighter federal steps aim to deflate crisis. P&T 2013;28;(9):531–534.