Citing Overdose Deaths in New Hampshire and Indiana, Senators Hassan and Braun Call on FDA to Update its Opioid Labelling Policies

WASHINGTON – U.S. Senators Maggie Hassan (D-NH) and Mike Braun (R-IN) are urging the Food and Drug Administration (FDA) to update its policies for labelling opioid prescriptions as overdose deaths in their respective states remain high.

“In 2021 alone, at least 216 Granite Staters lost their lives due to opioid overdoses, and 1,512 Hoosiers lost their lives due to opioid overdoses in Indiana,” the Senators wrote to FDA Commissioner Robert Califf. “Many people who die from an overdose first become addicted through a legal prescription for OxyContin or other FDA-approved drugs. Despite this harm, the FDA continues to permit doctors to prescribe these drugs to be sold under misleading and inaccurate labels. Now that you have been confirmed, an urgent priority must be to update the FDA’s opioid labeling policies to reflect current public health and safety knowledge.”

The Senators continued, “Big Pharma’s undue influence has led to the FDA making opioid-labeling decisions that exacerbate the opioid epidemic and contradict public health needs, and the FDA has kept these labels in place despite insufficient evidence of their safety and efficacy.”

The Senators’ letter calls on the FDA to make reforms to help fix the agency’s past errors and strengthen the regulation of opioids, including by:

• Revising the labeling of opioids by removing unsupported claims about their long-term efficacy;
• Removing the confusing term “abuse deterrent” from opioid labelling -- which is meant to indicate the drug is hard to crush or inject, but which many prescribers and patients believe means that it is less likely to cause addiction -- and replacing it with language that more accurately conveys the intended meaning;
• Evaluating the effectiveness of using a research design for clinical trials that allows Big Pharma to remove patients who are not responsive or have adverse effects to an opioid from the trial, which can lead to overstating a drug’s efficacy.

This letter builds on Senator Hassan’s efforts to combat the overprescribing of opioids that leads to addiction, as well as her work to hold the FDA accountable for its role in fueling the opioid crisis. During Dr. Califf's nomination hearing, Senator Hassan called upon him to address FDA’s inaction on opioid misuse and failure to fix labeling guidance issues for opioids. She also pressed Dr. Califf on the FDA’s approval of OxyContin. Furthermore, Senators Hassan and Ed Markey (D-MA) previously wrote to the FDA calling for a fuller accounting of the FDA’s past decision-making processes. Senators Joe Manchin (D-WV), Hassan, and colleagues also previously wrote to President Biden detailing concerns with the FDA’s previous decision making for prescription opioids and calling for new leadership at the FDA.

To read the Senators’ letter, click here or see below:

Dear Dr. Califf,

As you step into the role of Commissioner of the Food and Drug Administration (FDA), we urge you to take immediate action to address the opioid epidemic that continues to devastate communities across the country. In 2021 alone, at least 216 Granite Staters lost their lives due to opioid overdoses  and  Many people who die from an overdose first become addicted through a legal prescription for OxyContin or other FDA-approved drugs. Despite this harm, the FDA continues to permit doctors to prescribe these drugs to be sold under misleading and inaccurate labels. Now that you have been confirmed, an urgent priority must be to update the FDA’s opioid labeling policies to reflect current public health and safety knowledge.

As I outlined in your nomination hearing, the FDA has endangered the public health by approving flawed opioid labels multiple times. Big Pharma’s undue influence has led to the FDA making opioid-labeling decisions that exacerbate the opioid epidemic and contradict public health needs, and the FDA has kept these labels in place despite insufficient evidence of their safety and efficacy. For example, in 2001 the FDA permitted labels that indicate OxyContin for long-term use to treat chronic pain, a decision former FDA Commissioner David Kessler has since described as a mistake and “blank check” for the industry.

FDA now has an opportunity to fix these past errors and strengthen the regulation of opioids in order to save lives. We urge the FDA to pursue the following reforms:

Revise the Labeling for the Long-Term Use of Opioids

Currently, many opioid labels make claims about “daily, around the clock, long-term” efficacy. However, the Centers for Disease Control and Prevention concluded there was “insufficient evidence to determine whether pain relief is sustained and whether function or quality of life improves with long-term opioid therapy.”  It found “no study of opioid therapy versus placebo, no opioid therapy, or nonopioid therapy for chronic pain [that] evaluated long-term (≥1 year) outcomes related to pain, function, or quality of life.”  In February of this year, the Agency for Healthcare Research and Quality conducted a thorough literature review and found zero randomized control trials that evaluate the long-term benefits of opioids versus placebos.  In light of both of these government agency findings, we encourage FDA to revise the labeling of opioids by removing unsupported claims about their long-term efficacy.

Replace Abuse-Deterrent Language

FDA currently uses the term “abuse deterrent” in its labeling to convey that an opioid is harder to crush or inject. However, patients and providers often misunderstand the term, mistakenly believing that the drug is less likely to cause addiction.  FDA should immediately remove this term from product labels and identify evidence-based language that more accurately conveys the intended meaning.

Evaluate the Efficacy of Enriched Enrollment Randomized Withdrawal Trials

We are also concerned by the ongoing use of enriched enrollment randomized withdrawal (EERW) research designs for clinical trials. Opioid manufacturers have used this research design to artificially inflate the effectiveness of the drug in the clinical trial by removing patients who are not responsive or have adverse effects. This research design limits the generalizability of the trials, underestimating the frequency of adverse effects and overstating the drug’s efficacy.  As a result, opioids that were tested on a select group of homogenous individuals are being marketed for everyone. As a group of experts recently recommended in the Annals of Internal Medicine, FDA should “stop relying on EERW designs to assess opioid efficacy.”         

Physicians and other prescribers rely on the FDA’s label to guide and inform clinical decisions. The label should be based on the best available science, in order for medications to provide the most benefit for patients, with the least harm.

During your confirmation hearing, you stated, “I am committed to do a comprehensive review of the status of opioids early in my tenure…that would include everything, including the labels.” Our constituents expect you to act on this commitment, reduce the harm that opioids can cause to individuals, and restore the public’s trust in the FDA.

We look forward to seeing FDA address these issues. Please let us know the FDA’s plans and timelines for progress by May 18.

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