Leahy, Blumenthal Call On FDA To Expedite Review Of Pain Killers With Abuse-Deterrent Properties

(Washington, DC) – In a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) and U.S. Senator Richard Blumenthal (D-Conn.) urged the agency to expedite review of pain killers with built-in properties to curb abuse. Last year, the pain killer Zohydro ER was approved by the FDA despite lacking abuse-deterrent properties and over strong objections from the FDA’s own independent advisory committee. Many governors and state attorneys general believe this powerful drug is all but certain to exacerbate the nation’s addiction to opioids, which results in tens of thousands of overdose deaths each year. In the letter, Leahy and Blumenthal requested that the FDA brief them on plans to monitor the use of Zohydro ER, including what metrics will be used to potentially reevaluate its status as an approved drug if widespread problems develop.  Drug enforcement is an issue that will also be the subject of a separate Senate Judiciary Committee oversight hearing this week.

“Given their potency and ease of abuse, we have little doubt that pure opioid products may lead more Americans to addiction, some even to heroin,” the senators wrote.  “To the extent that pure opioid products fill a necessary niche in responsible pain management practices, the FDA must now take all available measures to ensure that patients are soon provided safer alternatives. This process begins by prioritizing review of abuse-deterrent formulations. Such formulations are much more difficult to crush or dissolve, two preferred methods of abuse.”

Full text of the letter is attached and below:

April 28, 2014

The Honorable Margaret Hamburg
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg: 

We are writing to urge the expedited review of New Drug Applications for abuse-deterrent formulations of single-entity hydrocodone products. Zohydro ER was the first pure hydrocodone product to receive FDA market approval. The drug was approved despite lacking any abuse-deterrent properties and over strong objections from the FDA’s own independent advisory committee. We share the concerns of the many governors and state attorneys general who believe this powerful drug is all but certain to exacerbate our nation’s addiction to opioid analgesics, which results in tens of thousands of overdose deaths each year.

Given their potency and ease of abuse, we have little doubt that pure opioid products may lead more Americans to addiction, some even to heroin.  The FDA has already recognized the heightened risks of overdose and death with Zohydro ER, even at recommended doses.  Drug developers continue to seek regulatory approval for other easy to abuse opioids, such as Moxduo IR.  To the extent that pure opioid products fill a necessary niche in responsible pain management practices, the FDA must now take all available measures to ensure that patients are soon provided safer alternatives. This process begins by prioritizing review of abuse-deterrent formulations. Such formulations are much more difficult to crush or dissolve, two preferred methods of abuse.

As safer, abuse-deterrent opioids are approved, the FDA should act swiftly to remove any older, less safe versions. In the past, it has taken up to three years for the FDA to ban products that lack abuse-deterrent properties when a safer equivalent exists. Americans should not have to wait this long with Zohydro ER.

We also request that the FDA brief our staff on your plans to monitor the use of Zohydro ER, including what metrics will be used to potentially reevaluate its status as an approved drug if widespread problems develop.  We also ask that you share your planned efforts to curb prescription drug abuse generally, including the development and approval of effective non-opioid painkillers that may finally break the cycle of opioid addiction. Each year, the opioid epidemic seeps into more communities and takes more lives. We are eager to learn how we can assist the FDA to finally get ahead of this scourge. 

Thank you for your prompt attention to this matter.  We look forward to hearing from you.

Sincerely,  

PATRICK J. LEAHY
United States Senate

RICHARD BLUMENTHAL
United States Senate

Press Contact

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