Citizen petition calls on FDA to pull powerful opioids from market

  • February 15, 2018

In their petition, representatives from the Association of State and Territorial Health Officials, National Safety Council, Physicians for Responsible Opioid Prescribing, American College of Medical Toxicology and Coalition to End the Opioid Epidemic urged the FDA that the risks of ultra-high dose opioids (UHDU) aren’t worth “modest” benefits.  Citing potential for misuse and overdose, the group argues that the FDA “should immediately seek removal of oral and transmucosal UHDU opioid analgesics from the market.”  An FDA representative said the Agency “is reviewing the petition and will respond directly to the petitioner.”  The petition pointed to OxyContin 80 mg, which is typically prescribed twice a day and IR oxycodone 30 mg, which is often prescribed four times a day, as examples.

The development comes as the United States continues to suffer from a opioid and addiction epidemic that is claiming lives around the country.  President Donald Trump recently declared the situation a national emergency.

Separately in early September 2017, Arizona filed suit against embattled Insys Therapeutics, alleging fraudulent marketing to boost sales for fentanyl painkiller Subsys.  Three doctors named in the suit were responsible for 64% of Subsys sales in Arizona from March 2012 to April 2017, according to the state.  That drug maker has faced a host of lawsuits and investigations into its promotion of the powerful opioid.

In late August 2017, Insys responded that statements in the Arizona suit “lack context and factual accuracy.”

Elsewhere, numerous cities, counties and states have sued various makers of opioid painkillers, with each case adding to the legal expenses of the defendants.

Recent lawsuits against opioid companies include one filed in early September 2017 by Waterbury, Connecticut, against Teva, Purdue, Johnson & Johnson and Endo, according to Westfair Online.  There also have been suits filed recently by Missouri, Ohio, and other states.  Many lawsuits claim the drug makers exaggerated the benefits of opioids and downplayed the risks.

In response to the suits, some drug makers have denied the allegations, while others declined to comment and some said they share concerns about the epidemic.

While the citizen petition is calling for the removal of certain opioids, the FDA has already pushed Endo International to pull its Opana ER from the market.  The drug maker caved to FDA pressure in July and said it had remove the drug that generated $160 million in sales last year.

Earlier in the summer of 2017, the FDA announced plans to take a new look at the risk-benefit profiles of approved opioids in response to the epidemic.

REFERENCE:  Fierce Pharma; 01 SEP 2017; Eric Sagonowosky

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