FDA chief deflects questions on fighting opioid epidemic if ACA is repealed


Modern Healthcare.com reports

The head of the Food and Drug Administration said he does not know how legislation to replace the Affordable Care Act will affect access to addiction treatment as the nation faces an overdose epidemic.

During a Senate appropriations hearing on Tuesday, Dr. Scott Gottlieb called the crisis one of the “biggest challenges” facing his agency and said the FDA was addressing the problem through a number of avenues, including approving opioids with better abuse deterrents.

But when pressed about the potential loss of access to treatment if Medicaid was cut by $800 billion as proposed by the House bill, Gottlieb deflected.

The president’s 2018 budget proposal for the FDA calls for a $854 million cut, down 31% compared with 2017. To offset the loss, the budget proposes a $1.3 billion increase in user fees, paid by drug and device makers and used to support staff that assesses new products. But the chair of the Senate Appropriations Committee recently announced they will not move forward with that proposal.

“I have not focused a lot of attention on the various legislation moving through with respect to the ACA,” Gottlieb said. “I am very focused on what I’m doing at FDA right now, which is more than a full-time job.”

Experts say any rollback of Medicaid expansion will surely and significantly impact millions who were able to get treatment for addiction.

More than 2 million people with substance abuse disorders, including more than 200,000 with opioid use disorders, have Medicaid coverage, according to the Center on Budget and Policy Priorities. And more than 50,000 Americans died from drug overdoses in 2015, according to data from the Centers for Disease Control and Prevention.

Earlier this month the FDA took steps to address the problem with an unprecedented move. The agency asked Endo Pharmaceuticals, maker of the extended-release pain reliever opioid Opana ER, to remove it from the market amid reports that the drug was being abused.

Gottlieb said the FDA is also addressing clinical prescribing practices.

“We know that most people who are going to become addicted to opioids are first exposed to opioid drugs in the clinical setting through legitimate prescription,” Gottlieb said. “It’s incumbent upon all of us to make sure that only properly indicated patients are being prescribed opioids.”

Gottlieb also wants to expand medication-assisted treatments by expediting the clinical trial process to get new therapies into patients’ hands more quickly.

Fewer areas of society have experienced the full impact of the opioid epidemic more than in healthcare, where opioid-related cases were responsible for more than 1.2 million emergency department visits or inpatient stays in 2014, according to a report released Tuesday by the Agency for Healthcare Research and Quality, with the number of hospitalizations increasing by 64% between 2005 and 2014.

Despite the rise, the percentage of people receiving help for their addiction has not changed over the past decade, with only about 20% in treatment between 2004 and 2013, according to a 2015 research letter featured in JAMA.

Access to drug treatment has proven difficult for all ages. In a study published Monday in JAMA Pediatrics, only 1 in 4 youth between the ages of 13 and 25 with an opioid use disorder had access to medication-assisted treatments such as buprenorphine and naltrexone.

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