Yesterday the FDA Science Board discussed the agency’s approach to opioids.
FDA presenters included agency point-man Doug Throckmorton (Deputy Director for Regulatory Programs, CDER), Janet Woodcock (Director, CDER), Sharon Hertz (Division Director, Division of Anesthesiology, Analgesia and Addiction Products), Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) – and newly confirmed FDA Commissioner Rob Califf.
Califf was there at the beginning of the meeting (expected) and stayed through the entire length of the day-long affair (unexpected). An important signal that he intends to be a hands-on leader.
I was chosen to speak during the open public comment part of the hearing, and spoke about using real-world information to provide providers and patients with information beyond the limited world of pivotal trials. Here are my brief remarks:
Former Canadian Prime Minister Pierre Trudeau once said, “There's no place for the state in the bedrooms of the nation.“ But what’s the appropriate place for the state in examination rooms, pharmacies and medicine chests – particularly for opioids? There is no such thing as a medicine that is 100% abuse-proof. The only abuse-proof medicine is one that is never prescribed – and for the tens of millions of Americans suffering from chronic pain that isn’t a viable option.
Advancing the manufacturing science of abuse deterrence is an important step in the right direction. According to the Journal of Pain, in a real-world study, abuse by snorting, smoking, and injecting prescription opioids declined by 66% after the reformulation of a drug with abuse deterrent properties. And the New England Journal of Medicine reported that a new formulation decreased abuse from 35.6% of respondents to 12.8% in 21 months.
But cutting the Gordian Knot of abuse means more than advancing the science of abuse deterrence. It means working with the providers of Continuing Medical Education to develop better curricula. It means more targeted Risk Evaluation and Mitigation Strategies. It means enhanced and validated reporting tools for post-marketing surveillance. And it means using real world data to provide real world advice. It means using that data for better social science tools that can assist prescribers in determining which patients are likely to abuse.
“Abuse deterrence” isn’t just a formulation question – it’s a systems question.
What about the issues surrounding opioid misuse – at present the poor public health stepchild of abuse? And how can better physician education defer or deter the prevalent “opioids first” prescribing philosophy of many practitioners?
In the U.S., the use of opioids as first-line treatment for chronic pain conditions follows neither label indications or guideline recommendations. 52% of patients diagnosed with osteoarthritis receive an opioid pain medicine as first line treatment as do 43% of patients diagnosed with fibromyalgia and 42% of patients with diabetic peripheral neuropathy.
Payers often implement barriers to the use of branded, on-label non-opioid medicines, relegating these treatments to second line options – along with new abuse-deterrent opioid formulations. The result is a gateway to abuse and addiction.
Various pieces of state legislation are trying to correct this, but there has to be a better way.
The FDA can play an important role in working to develop and share (with a broad constituency) validated tools for physicians to use in determining which patients may be more prone to slide into abuse so they can choose their therapeutic recommendations more precisely.
The FDA has announced labeling changes and post-market study requirements for opioids, and the agency has signaled interest in using real world outcomes data to amend and update labeling. That’s not regulatory mission creep; it’s the appropriate application of the agency’s Safe Use of Drugs initiative. The way you make a drug “safer” is to ensure that it is prescribed to the right patient and used in the proper manner.
A logical next step is to utilize that real world data to amend product-specific abuse-deterrent labeling to indicate lessons learned outside of the rarified world of the randomized clinical trial environment to assist physicians in using the right product for the right patient. Such changes mark important steps in highlighting the value of individualized patient pain-management programs.
Abuse-deterrent technologies are an important step in the right direction. They are part of the solution, but they’re not the whole solution.
It’s important to remember that the vast majority of people who use opioids do so legally and safely. In fact, government statistics show that 78.5% of those who abuse prescription pain medication did not obtain the drugs from a doctor in the first place.
Abuse deterrence is a worthy goal and will only evolve when all the players work together in a more regular and synchronistic fashion. As the Japanese proverb goes, “Don’t fix the blame, fix the problem.”
FDA presenters included agency point-man Doug Throckmorton (Deputy Director for Regulatory Programs, CDER), Janet Woodcock (Director, CDER), Sharon Hertz (Division Director, Division of Anesthesiology, Analgesia and Addiction Products), Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) – and newly confirmed FDA Commissioner Rob Califf.
Califf was there at the beginning of the meeting (expected) and stayed through the entire length of the day-long affair (unexpected). An important signal that he intends to be a hands-on leader.
I was chosen to speak during the open public comment part of the hearing, and spoke about using real-world information to provide providers and patients with information beyond the limited world of pivotal trials. Here are my brief remarks:
Former Canadian Prime Minister Pierre Trudeau once said, “There's no place for the state in the bedrooms of the nation.“ But what’s the appropriate place for the state in examination rooms, pharmacies and medicine chests – particularly for opioids? There is no such thing as a medicine that is 100% abuse-proof. The only abuse-proof medicine is one that is never prescribed – and for the tens of millions of Americans suffering from chronic pain that isn’t a viable option.
Advancing the manufacturing science of abuse deterrence is an important step in the right direction. According to the Journal of Pain, in a real-world study, abuse by snorting, smoking, and injecting prescription opioids declined by 66% after the reformulation of a drug with abuse deterrent properties. And the New England Journal of Medicine reported that a new formulation decreased abuse from 35.6% of respondents to 12.8% in 21 months.
But cutting the Gordian Knot of abuse means more than advancing the science of abuse deterrence. It means working with the providers of Continuing Medical Education to develop better curricula. It means more targeted Risk Evaluation and Mitigation Strategies. It means enhanced and validated reporting tools for post-marketing surveillance. And it means using real world data to provide real world advice. It means using that data for better social science tools that can assist prescribers in determining which patients are likely to abuse.
“Abuse deterrence” isn’t just a formulation question – it’s a systems question.
What about the issues surrounding opioid misuse – at present the poor public health stepchild of abuse? And how can better physician education defer or deter the prevalent “opioids first” prescribing philosophy of many practitioners?
In the U.S., the use of opioids as first-line treatment for chronic pain conditions follows neither label indications or guideline recommendations. 52% of patients diagnosed with osteoarthritis receive an opioid pain medicine as first line treatment as do 43% of patients diagnosed with fibromyalgia and 42% of patients with diabetic peripheral neuropathy.
Payers often implement barriers to the use of branded, on-label non-opioid medicines, relegating these treatments to second line options – along with new abuse-deterrent opioid formulations. The result is a gateway to abuse and addiction.
Various pieces of state legislation are trying to correct this, but there has to be a better way.
The FDA can play an important role in working to develop and share (with a broad constituency) validated tools for physicians to use in determining which patients may be more prone to slide into abuse so they can choose their therapeutic recommendations more precisely.
The FDA has announced labeling changes and post-market study requirements for opioids, and the agency has signaled interest in using real world outcomes data to amend and update labeling. That’s not regulatory mission creep; it’s the appropriate application of the agency’s Safe Use of Drugs initiative. The way you make a drug “safer” is to ensure that it is prescribed to the right patient and used in the proper manner.
A logical next step is to utilize that real world data to amend product-specific abuse-deterrent labeling to indicate lessons learned outside of the rarified world of the randomized clinical trial environment to assist physicians in using the right product for the right patient. Such changes mark important steps in highlighting the value of individualized patient pain-management programs.
Abuse-deterrent technologies are an important step in the right direction. They are part of the solution, but they’re not the whole solution.
It’s important to remember that the vast majority of people who use opioids do so legally and safely. In fact, government statistics show that 78.5% of those who abuse prescription pain medication did not obtain the drugs from a doctor in the first place.
Abuse deterrence is a worthy goal and will only evolve when all the players work together in a more regular and synchronistic fashion. As the Japanese proverb goes, “Don’t fix the blame, fix the problem.”
