WASHINGTON, D.C. – Following the troubling decision by the Food and Drug Administration (FDA) to approve the use of the opioid prescription painkiller OxyContin for children as young as eleven years old, U.S. Senator Angus King (I-Maine) has joined with a bipartisan group of senators to send a letter expressing concern and asking the agency why it approved the pediatric prescription use of OxyContin without the benefit of an independent Advisory Committee review.

“The country is in the midst of an opioid abuse crisis, with more than 2 million Americans aged 12 or older abusing or dependent on opioids,” wrote the Senators in their letter to the FDA. “Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers like OxyContin. We recognize that, in serious cases, children may need appropriately approved and prescribed narcotics.  But an increase in the availability of opioids like OxyContin to children — and the potential for abuse — poses a serious U.S. public-health issue.”

The FDA’s own regulations mandate that it conduct an independent Advisory Committee Review when a matter is of significant public interest, highly controversial, or requires a special type of expertise. Despite the fact that the question of children using powerful, dependency-inducing opioids meets all three of those standards, the FDA failed to conduct such a review. Additionally, it is not clear whether the FDA sought any information about the potential for addiction and abuse by children. Children, whose brains are not yet fully developed, are especially vulnerable to drug dependency and abuse.

Senators Edward Markey (D-Mass.), Kelly Ayotte (R-N.H.), Joe Manchin (D-W.V.), Dianne Feinstein (D-Calif.), Tim Kaine (D-Va.), Jeanne Shaheen (D-N.H.), and Dick Durbin (D-Ill.) also signed the letter, which was sent last Friday. A copy of the letter to the FDA can be found HERE.

Senator King also recently joined a bipartisan group of colleges to send a letter to the leaders of the Senate Health, Education, Labor, and Pensions Committee urging a separate Congressional investigation into the FDA decision and the process that led the agency to its troubling decision. 

These two letters follow a roundtable discussion last month convened by Senator King and Director of National Drug Control Policy Michael Botticelli in Brewer that focused on how to build on current federal policies to better address the threat that opioid abuse poses to personal and public health and safety. Senator King is a member of the Senate Prescription Drug Abuse Caucus.

The text of the Senators’ letter to the FDA is below:

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September 18, 2015

The Honorable Stephen Ostroff, Acting Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Acting Commissioner Ostroff:

We write to express our dismay over the FDA’s recent approval of the opioid prescription painkiller OxyContin for use by children as young as 11 years old and to request additional information about this troubling decision.

The country is in the midst of an opioid abuse crisis, with more than 2 million Americans aged 12 or older abusing or dependent on opioids.  Approximately 38,000 people die each year from drug overdoses — more than 100 per day — and opioids play a large role in this tragedy.  Opioid overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers like OxyContin.

Children, whose brains are not yet fully developed, are especially vulnerable to drug dependency and abuse.  In 2012, an estimated 2.4 million adolescents aged 12 to 17 reported using an illicit drug in the previous month.  Illicit drug use negatively impacts adolescent behavior, as well as physical and mental development.  Moreover, substance-abusing adolescents are more likely to engage in substance abuse or become substance-dependent as adults.

We recognize that, in serious cases, children may need appropriately approved and prescribed narcotics.  But an increase in the availability of opioids like OxyContin to children — and the potential for abuse — poses a serious U.S. public-health issue.

Despite the obvious and alarming concerns about the potential for abuse by pre-teens and teenagers, the FDA approved the pediatric prescription use of OxyContin without the benefit of an independent Advisory Committee review.  The FDA eschewed such a review despite its own regulations mandating one when a matter is of significant public interest, highly controversial, or requires a special type of expertise.  The question whether the FDA should approve for children the indication of a powerful, dependency-inducing opioid patently implicated each of those factors.

Furthermore, while the FDA has publicly explained that it required OxyContin’s manufacturer to evaluate its safety and metabolization in pediatric patients, the FDA apparently did not seek any information about the potential for addiction and abuse by children.  That is disconcerting. 

Accordingly, we respectfully ask that you provide responses to the following questions and document-production requests:

1.      Please explain the basis for the FDA’s decision to forego an Advisory Committee on the question of pediatric indication for OxyContin, including an explanation why the standing Pediatric Advisory Committee was not asked to review the matter.  If there are any associated memoranda and correspondence that may assist us in better understanding the FDA decision, please provide them.

2.      Please identify any studies the FDA required OxyContin’s manufacturer to conduct before approving the pediatric indication, including identifying the conditions or diseases that were the subject of the studies.  Please also identify any factors besides safety and metabolization in pediatric patients that the FDA required OxyContin’s manufacturer to evaluate before the FDA approved the pediatric indication.

3.      Please explain whether, and if so, how the FDA considered the issues of abuse or addiction by children prescribed OxyContin before the FDA approved the new pediatric indication.  If there are any associated memoranda and correspondence that may assist us in understanding how FDA considered these issues, please provide them.  If the FDA didn’t consider such issues, why not?

1. Is it the FDA’s position that the current “black box” warning for OxyContin is adequate for pediatric use, and that there is no need for specific mention of addiction risks in younger patients, even though, as referenced above, children are especially vulnerable to drug dependency and abuse?  If so, please explain why.

5.      In connection with the approval of the pediatric indication for OxyContin, the FDA explained:  “Similar to adults, OxyContin is approved for use in [certain pediatric] patients to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.”  Under that standard, could a severely broken bone or another acute injury qualify for pediatric OxyContin use, as opposed to a chronic condition like cancer?  In this regard, please identify the types — including specific examples — of medical conditions for which pediatric use of OxyContin is indicated, as well as those for which it is not. 

6.      The FDA has stated that “[t]he care of pediatric patients treated with an opioid analgesic has to be properly coordinated by a health care team experienced in opioid treatment.” Please describe how you plan to ensure that patients treated with these medications are managed by experienced care teams, and what efforts are underway to educate providers regarding the pediatric-specific risks associated with use of these opioid treatments and the appropriate protocols for managing both the initiation and termination of use.

7.      Please identify the information that physicians prescribing OxyContin under the new pediatric indication are required to provide to parents of children receiving the drug, including information about potential abuse or dependency.  If the FDA did not require physicians to provide such information to parents of children being prescribed OxyContin, please explain why not.

8.      Please explain how the FDA will be tracking abuse or dependency caused by pediatric use of OxyContin.  For example, will the FDA be using its adverse-reporting database or post-market studies?  Will it be working with other agencies like the Centers for Disease Control to track abuse or changes in patterns of use among the pediatric population?  If not, please explain why not.

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