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Group focusing on opioid abuse calls for new leadership at FDA

A coalition of doctors and addiction experts Wednesday are calling for new leadership at the U.S. Food and Drug Administration, claiming misguided policies are exacerbating the nation's opioid epidemic.

In a letter sent to Department of Health and Human Services Secretary Sylvia Burwell, who has jurisdiction over the FDA, the coalition's members said regulatory decisions by FDA leaders have contributed to a national surge in pain pill addiction and overdose deaths.

"The existing FDA leadership is totally out of touch with this crisis and the way it is devastating families and communities," said Dr. Andrew Kolodny of Queens, president of Physicians for Responsible Opioid Prescribing and a member of the advocacy coalition, known as Fed Up! "Their decisions are making a serious public health problem even worse."

Going against the recommendation of its own panel of outside advisers, the FDA last year approved Zohydro ER, a powerful, pure hydrocodone painkiller without features to deter abuse.

Long Island law enforcement agencies and drug-addiction experts at the time said the new opioid pill would likely create more addicts and cause even more overdose deaths. Zohydro, the first pure hydrocodone medication available in the United States, went on sale in March.

Another high-dose opioid painkiller, Targiniq ER, was approved by the FDA in July.

The FDA is headed by Commissioner Margaret Hamburg, who has been criticized by some addiction specialists and doctors as doing too little to curb opioid abuse.

"Until FDA changes course on opioids, it will be impossible to control this crisis," coalition member Peter Jackson, president of Advocates for the Reform of Prescription Opioids and father of an 18-year-old girl who fatally overdosed in 2006 on OxyContin, said in an statement. "The FDA should be putting the public's health ahead of drug company profits."

But FDA spokesman Jeff Ventura, calling opioid abuse one of the "top public health priorities" for the agency, defended Hamburg. "Dr. Hamburg has been a tireless public health advocate for more than 20 years and is committed to continuing to champion the rights of patients as Commissioner of the FDA," he said in an emailed statement.

Deaths nationwide from opioid painkillers like OxyContin, Vicodin and their generic equivalents nearly quadrupled between 1999 and 2011, rising from 4,263 to nearly 17,000, according to the U.S. Centers for Disease Control and Prevention.

Opioid pain pills killed fewer people on Long Island in 2013 than in years past, records show. In Suffolk, pills containing opioid medications -- oxycodone, hydrocodone and hydromorphone -- played a role in 137 overdose deaths in 2012 and at least 107 in 2013, the most recent year with statistics available.

In Nassau, opioid pills were linked to 56 overdose deaths in 2012 and at least 43 in 2013, records show.

Experts say higher rates of opioid pill addiction in years past have also led to more heroin overdose deaths, since heroin is cheaper than pain pills and offers a similar high.

Heroin overdoses killed a record-high 144 people on Long Island in 2013. In York City, heroin overdose deaths have doubled over the past three years -- from 209 in 2010 to 420 last year.

Fed Up! is holding a march in Washington on Sunday to call for more federal action to combat opioid abuse.

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