Lawmaker calling for immediate reform of FDA approval process for opioid painkillers fueling prescription drug and heroin epidemic

Boston (January 25, 2016) – Senator Edward J. Markey (D-Mass.) today announced he has placed a hold on Food and Drug Administration  (FDA) Commissioner nominee Dr. Robert Califf, calling for immediate reforms to the agency’s approval process for opioid painkillers, which are fueling a prescription drug and heroin overdose crisis that led to 27,000 deaths, including more than 1,300 in Massachusetts, in 2014. Specifically, Senator Markey is calling for the FDA’s commitment to convene advisory committees for any future opioid-approval questions; to consider addiction, abuse and dependence as part of its determinations of which opioids are ‘safe’; and to rescind the approval of OxyContin for kids and convene an advisory panel to provide direction as it reconsiders that decision. Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even thought its guidelines note that FDA decisions that relate to controversial issues or matters relating to children are particularly well-suited to advisory committee empanelment.
“While people in every community across the country are dying every day from opioid overdoses, the FDA continues to operate as if safety just means the right dose when it should include all the dangers of these painkillers,” said Senator Markey. “Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs. The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination. Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family.”
Senator Markey met with Dr. Califf in November 2015 to express his concerns about the FDA’s repeated approval of applications for ever more powerful opioid painkillers submitted by the pharmaceutical industry and its failure to seek and follow expert advice. Medical, public health, law enforcement and other experts have all pointed to the increasing over-prescription of these painkillers as a primary driver of the opioid epidemic. Senator Markey then followed up with a letter to Department of Health and Human Services Secretary (HHS) Sylvia Burwell outlining the three steps he wants to agency to take before he can support the nomination of Dr. Califf.
“Tragically, we have become the United States of Oxy,” continued Senator Markey. “We are five percent of the world’s population but consume 80 percent of the world’s supply of Oxycodone. We need to stop the over-prescription of pain medication that is fueling this crisis and ensure that all prescribers are required to receive education in responsible prescribing practices.”
In the last several years, the FDA has either not convened experts into advisory committees to approve several new opioid painkillers, or in one instance, ignored the overwhelming opinion of a committee that voted against approval of the powerful opioid drug Zohydro.

  • In 2012, the Zohydro panel voted 11-2 against approving the drug, but the FDA overruled its own experts and approved Zohydro anyway.
  • In July 2014, the FDA approved Targiniq ER, an extended release/long-acting opioid analgesic, without convening an advisory committee.
  • In November 2014, the FDA approved Hysingla, an extended release opioid analgesic, without convening an advisory committee.
  • In August 2015, the FDA approved a new pediatric indication for OxyContin without convening an advisory committee.

The Drug Enforcement Agency (DEA) approved the production of 149,375,000 grams of Oxycodone – the active ingredient in OxyContin – in 2014, a more than 300 percent increase over 2000. That amount is equivalent to nearly 15 billion ten-milligram pills. In his recent State of the Union address, President Obama made specific and unscripted mention of working with Congress to address the heroin and drug addiction crisis. Senator Markey has pledged to make addressing the prescription drug and heroin crisis his top legislative priority this Congress.
In May 2015, Senator Markey and Senate Majority Leader Mitch McConnell (R-Ky.) first called on HHS to issue a Surgeon General’s Report and Call to Action on prescription drug and heroin abuse, which HHS then announced last fall that it will complete in 2016.
Senator Markey has introduced the Safe Prescribing of Controlled Substances Act, which would require prescribers of opioid pain medications and other controlled substances to undergo mandatory training on safe prescribing practices and the identification of possible substance use disorders. Additionally, Senator Markey has introduced the Treatment and Recovery Investment Act to increase funding for states so they can better assist individuals with substance use disorders.
In 2014, Senator Markey released a comprehensive plan to address the opioid epidemic. The plan outlines the broad range of actions – prevention, treatment and enforcement – that must work in unison to address the crisis. A full overview of Senator Markey’s efforts to address the heroin and prescription drug crisis can be found HERE.