NCHR Testimony at 2016 FDA Science Board Meeting on Opioids

Testimony of Dr. Tracy Rupp
FDA Science Board Meeting on Opioids

Thank you for the opportunity to speak today. My name is Dr. Tracy Rupp. I was previously a clinical pharmacist at Duke University Medical Center and am now the Director of Public Health Policy Initiatives at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers. We do not accept funding from the drug or medical device industry and I have no conflicts of interest.

Our Center strongly supports research and programs to improve the safety of opioids. In 2014, more Americans died of opioid overdose than any other year on record, so a rethinking of the risk-benefit framework for these drugs is long overdue. An important first step is for the FDA to determine whether current risk evaluation and mitigation strategies (REMS) for opioids are effective.

 REMS were developed to enable the FDA to approve drugs with serious risks, like opioids, by providing a mechanism to mitigate those risks. Long-acting opioids are currently subject to a REMS program that requires sponsors to fund continuing medical education (CME) courses on the appropriate use of these products.

We agree with the FDA’s new plan to develop warnings and safety information, such as REMS, for immediate-release opioids. Most patients who become addicted to opioids are initially prescribed the immediate-release dosage form. But, we are concerned that REMS training that is industry-sponsored poses an inherent conflict of interest. Published literature indicates that many of these courses imply that opioids are safe and effective for chronic non-cancer pain.  They are not providing unbiased information about the risks and benefits, or information about other non-opioid treatment options.

The FDA recently released a plan to increase the number of prescribers who receive REMS training on pain management and safe prescribing of opioid drugs. The goal is to reduce inappropriate opioid prescribing. But, the fact is that we don’t know whether opioid REMS are effective at reducing either inappropriate prescribing or opioid abuse.  Whatever data exists is not publicly available. In fact, in 2013, the inspector general reported that even the FDA lacks comprehensive data to determine if REMS improve drug safety. Nearly half of all sponsor assessments for the 49 REMS that were reviewed did not include all information requested by the FDA, and only 7 of the 49 REMS met all of their goals.

 Only 1 of 19 REMS with Elements To Assure Safe Use (ETASUs), which are required for the riskiest drugs, was meeting all of its goals.

When it was determined that REMS were not meeting all of their goals, lack of patient and prescriber awareness of risks was the most common problem.

The law requires the FDA to review sponsors’ assessments of REMS but does not require it to perform its own assessments of each REMS. Currently, we must rely on the drug sponsor to accurately assess the program but the data are not publicly available so that we can judge for ourselves. The FDA should perform its own independent assessment of the effectiveness of opioid REMS and make the data publicly available on the FDA’s website. This would allow stakeholders to perform their own assessment of the program’s effectiveness.

Drug safety depends on vigilance and communication from pharmacists, physicians, and patients. Adverse event reporting from health care systems and researchers is an important tool to inform the FDA of new safety risks and can prompt regulatory actions when new benefit-risk information comes to light.

In conclusion, opioid abuse is a crisis in the US.  We urge the FDA to perform its own independent assessment of the effectiveness of REMS and make this data publicly available. More transparency is needed to enable us all to work together to find more effective solutions to the challenge of opioid abuse.

Thank you for the opportunity to comment today and for consideration of our views.