May 06, 2016

Kaine Urges FDA To Approve Mandatory Prescriber Training On Opioids

WASHINGTON, D.C. – U.S. Senator Tim Kaine joined six of his Senate colleagues in calling on the Food and Drug Administration (FDA) to swiftly implement an advisory committee’s recommendations to approve mandatory education and training for prescribers of extended-release and long-acting (ER/LA) opioids, which were praised by the Washington Post’s editorial board. The Senators also asked the FDA to broaden the scope of the agency’s existing risk management strategy to include immediate-release opioids, which account for 91 percent of all opioid prescriptions. Kaine has met with families, health care providers, and law enforcement officers across Virginia impacted by prescription drug and heroin abuse and has pushed for changes at the federal level to end the opioid epidemic that caused more deaths in the Commonwealth than vehicle accidents in 2014.

“[The] lack of prescriber awareness, and more alarmingly, actual prescriber training on opioid abuse, misuse, and addiction is distressing to say the least. In an effort to continue combatting the opioid epidemic, we believe that your agency must make mandatory prescriber training and incorporating immediate-release opioid analgesics central components of an effective risk management strategy,” the Senators wrote. “While this will not cure our nation’s addiction to opioids alone, it is a logical and long advised step in the right direction.”

Joining Kaine in signing the letter are U.S. Senators Richard Blumenthal, Dick Durbin, Edward J. Markey, Joe Manchin, Dianne Feinstein and Kirsten Gillibrand.

The full text of the letter is available below.

May 5, 2016

The Honorable Robert Califf, M.D.
Commissioner
United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland  20993

Dear Commissioner Califf,

As you are aware, the Centers for Disease Control and Prevention (CDC) has declared prescription drug abuse a national epidemic, with the amount of painkillers dispensed in the United States quadrupling since 1999.[1] This severe uptick in prescription drug distribution has coincided with a quadrupling in prescription painkiller overdose deaths. The epidemic shows no signs of slowing, with 78 Americans dying every day as a result of an opioid overdose.[2] We write to encourage the Food and Drug Administration (FDA) to take immediate actions to curb the upstream drivers of this epidemic.

Following today’s joint meeting of the FDA’s Drug Safety and Risk Management (DSaRM) Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) on the extended-release and long-acting (ER/LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS), we strongly encourage the FDA to expeditiously broaden the scope of the REMS program to include immediate-release (IR) opioid analgesics and approve a change that would require mandatory education and training for prescribers.

While we appreciate the FDA’s recent commitment to address the opioid epidemic outlined in the agency’s Opioid Action Plan, we believe that the sheer scale and toll of the current opioid epidemic necessitates that the FDA continues to treat, as was recently announced through safety labeling changes for IR opioid analgesics, the abuse and misuse potential of IR opioid analgesics in a commensurate manner with that of ER/LA opioid analgesics. As IR opioid analgesics comprise 91 percent of all opioids prescribed, the FDA should expand the scope of REMS to IR opioid analgesics – as was recommended by both the FDA’s DSaRM and Anesthetic and Life Support Drugs Advisory Committee in 2010.[3]   

In its current form, the REMS program has been wholly unsuccessful in its stated goal of reducing serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics. The FDA has noted that the “central component of the ER/LA opioid analgesics REMS is an education program for prescribers (e.g., physicians, nurse practitioners, physician assistants).” That is why the FDA-approved REMS for ER/LA opioid analgesics requires companies to make available training on proper prescribing practices, at little or no cost, to health care professionals who prescribe ER/LA opioid analgesics. These companies are also required to distribute to prescribers and patients educational materials on the safe use of these powerful pain medications.[4] However, the ER/LA REMS stops short of mandating this education and training for prescribers of opioids. This has created a severe shortage of prescribers actually utilizing a central educational component of the REMS, inevitably leading to less safe prescribing practices and a less effective risk management strategy. Although a prescriber education requirement through the ER/LA REMS would neither impose an obligation directly on physicians nor be enforceable directly against them, requiring pharmaceutical companies to take steps to ensure that the opioids they manufacture are prescribed properly would be a step in the right direction.

The FDA set targets in 2012 under the ER/LA REMS for pharmaceutical companies, and one of them was to train 50 percent – or 80,000 prescribers – within two years of the program’s implementation.[5] Continuing education (CE) for ER/LA under this REMS was first available on March 1, 2013.[6] Following a request from Senator Blumenthal’s office, the FDA reported that at the two-year mark of this training first becoming available, less than half – just 37,512 prescribers – had been trained. Further, because this existing training is not mandatory, nearly 40 percent of prescribers reported being unaware of the programs months after they began.[7] Overall, compared to the estimated 320,000 ER/LA opioid analgesic prescribers, these figures are troubling.

This lack of prescriber awareness, and more alarmingly, actual prescriber training on opioid abuse, misuse, and addiction is distressing to say the least. In an effort to continue combatting the opioid epidemic, we believe that your agency must make mandatory prescriber training and incorporating IR opioid analgesics central components of an effective risk management strategy. While this will not cure our nation’s addiction to opioids alone, it is a logical and long advised step in the right direction.

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[1] Centers for Disease Control and Prevention. “Injury Prevention & Control: Prescription Drug Overdose” Data Overview (Mar. 14, 2016). http://www.cdc.gov/drugoverdose/data/.
[2] Centers for Disease Control and Prevention. “Injury Prevention & Control: Opioid Overdose” Understanding the Epidemic (Mar. 14, 2016). http://www.cdc.gov/drugoverdose/epidemic/.
[3] Brooks, Marta J. Mitigating the Safety Risks of Drugs with a Focus on Opioids: Are Risk Evaluation and Mitigation Strategies the Answer?, Mayo Clinic Proceedings (Dec. 2014) http://www.mayoclinicproceedings.org/article/S0025-6196(14)00794-0/fulltext.
[4] U.S. Food and Drug Administration. “Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics” (Mar. 1, 2013). http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm.
[5] Id.
[6] Id.
[7] NBC News. “FDA Reconsiders Painkiller Training Requirements for Doctors” (May 2, 2016). http://www.nbcnews.com/health/health-news/fda-reconsiders-painkiller-training-requirements-doctors-n565866.