Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments
CDER 2017-77 Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting A Scientific Discussion of Present and Future Capabilities Public Workshop Issues Paper Request for Comments OPEN
2017-07-13 2017-09-12 2017-09-12 2017-07-13 2017-08-07 2017-09-12 2017-09-11 2017-07-14
FDA-2017-N-2903-0004 FDA-2017-N-2903-0014 FDA-2017-N-2903-0013 FDA-2017-N-2903-0003 FDA-2017-N-2903-0006 FDA-2017-N-2903-0015 FDA-2017-N-2903-0008 FDA-2017-N-2903-0005
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https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0004 https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0014 https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0013 https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0003 https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0006 https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0015 https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0008 https://api.regulations.gov/v4/comments/FDA-2017-N-2903-0005
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1) NomenclatureTo call tamper-resistant opioids Abuse Deterrent Formulations (ADFs) substantially misstates what these technologies can accomplish even if and when they work as intended.  The Food and Drug Administration (FDA) is a scientific agency that should subscribe to maintain standards of accuracy, especially when communicating with the public and with stakeholders on issue of such grave importance.  Accordingly, the term ADFs should be abandoned in favor of a more accurate terminology.2) Vaccines  MeasurementAs was discussed during the public meeting, the appropriate analogy to draw when discussing the effort to elevate all licit opioid-prescribing is to vaccination, which must prove safe and effective for the recipient, and must also provide a herd immunity or substantial public health benefits in outcomes of interest. In order to judge tamper-resistant technology, two separate scales should be considered.3) Scale 1Considering the denominator all prescription pain pill users (adherent patients as well as misusing patients and recreational misuse), the FDA should itself sponsor prospective studies of tamper-resistant technologies based on categories of type (not a particular brand).  Particular brands should then be asked to match or outperform those results.  Entirely new innovations should be judged against similar products with proven results.  Any brand that agrees to place its product in the bucket study should be rewarded, if the technology is proven effective, with increased market penetration.  The outcome of interest here is: in this community of users, does the technology thwart attempts to manipulate it without incurring new or exacerbating existing hazards?4) Scale 2The denominators of interest here are all adverse outcomes: overdose death totals; overdose totals; Hep C or HIV infection rates; etc.  The buckets of technology-types and/or individual brands supply the numerator.  If these technologies successfully deter manipulation but do not meaningfully affect outcomes vital to abatement of the opioid crisis, then there is a limit to the kinds of vaccination or public health claims that can be made on their behalf.  On the other hand, if they can be shown as effective, it is important to seize on that knowledge and advance their market penetration.Kathleen J. Frydl Inflexxion, Inc. - Comments re: Data and Methods for Evaluating the Impact of Abuse-Deterrent Opioid Formulations On behalf of McKesson, I am pleased to submit comments on FDAs notice, Data and Methods for Evaluating the Impact of Opioid Formulations With Properties Designed To Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities; Public Workshop; Issues Paper; Request for Comments. Preventing Prescription Opioid Addiction Reduces Reliance on Abuse Deterrent Formulations  while Treating Chronic PainWhile the focus of this initiative is to evaluate opioid formulations that are identified as abuse deterrent, the fact is that the recreational  abuse of opioids is proceeded by addiction to the opioids. It is just common sense: As with most diseases, preventing opioid addiction is a lot better than needing to  treat it or, for that matter,  trying to avoid ways those addicted can administer it to achieve a greater high .In May, Dr. Scott Gottlieb, the new FDA Commissioner, declared that addressing the opioid epidemic is his first and highest priority. In his FDA VOICE blog, he cites data unequivocally establishing prescription opioids as the major cause of opioid addiction. These medications are also gateway drugs: Some 75 percent of heroin users in treatment began their addiction with prescription opioids. Prescription opioids are responsible for the majority of opioid-overdose deaths, responsible for about 22,000 of the 33,091 fatalities in 2015. The Agency for Healthcare Research and Quality reported 1.27-million emergency-room visits or inpatient stays for opioid-related issues in 2014 (the most recent year for which data is available). The public debates over legal and regulatory policies to combat this epidemic are ongoing, with opinions continuing to evolve. Yet discussions mainly fail to consider another vital concern: the medically legitimate needs of people who require prescription opioids to help live with chronic pain. The inconvenient truth is that moderate-to-severe chronic pain typically cannot be adequately controlled with non-opioids. One highly promising solution to this dilemma focuses on an underutilized treatment for chronic pain called buprenorphine (bu-pren-or-fin). It is the only opioid in the CIII schedule of drugs, a category recognized by the FDA as representing a reduced risk of addiction. All other opioids for pain are grouped in the riskier CII class. Until recently, buprenorphine was only available as a once-a-week transdermal (skin) patch, which limited its efficacy and caused some doctors to eschew it. Early last year, however, the FDA approved a twice-daily formulation of buprenorphine that provides significant pain relief: a small, transparent film resembling a Listerine breath strip that dissolves against the inside of the cheek.In this new form, buprenorphine may play a key role in fighting the prescription-opioid epidemic. It is the least addicting of all the opioids. It typically does not lead to withdrawal symptoms when stopped. Importantly, it reduces the risk of death due to overdose because it doesnt shut down respiration the way other opioids can.Buprenorphine is not immune to abuse, especially by people whove never before taken prescription-opioid medicationthe so-called opioid-nave. But it poses much less risk than CII opioids because it doesnt produce the same kind of potentially addictive euphoria. People living with chronic pain can get relief from buprenorphine but addicts looking for a high dont like the drug very much, according to studies.The FDA has approved high-dose buprenorphine (generally, over ten times the amount approved for pain management) as a treatment for opioid addiction. The advantage of buprenorphine is that it can eliminate withdrawal symptoms without triggering euphoria. This is in stark contrast to the use of methadone to treat heroin addiction. The dual ability of buprenorphine to both manage pain and also addiction underscores its uniqueness.The danger posed by CII opioids is real and immediate. In an analysis by the Centers for Disease Control and Prevention, the longer the exposure of opioid-nave patients to CII opioids, the greater the risk of becoming a chronic user. A one-day supply is associated with a 6 percent risk of continuing the opioid for at least a year; a 30-day supply is associated with about a 35-percent risk of becoming a chronic user. There are common-sense conclusions to be drawn here. For chronic-pain patients who are not getting adequate relief from non-opioids, prescribers should be required to offer buprenorphine as a first-line therapy before resorting to a CII opioid.  For patients who have been on a CII-opioid long-term, the mandate should be to gradually replace the medication with buprenorphine. The quickest and most effective way to encourage this change is for pharmacy benefit-management companies to adopt these requirements nationally. In addition, the FDA should mandate labelling changes for all CII opioids, requiring that prescribers try buprenorphine first as a treatment for chronic pain. I look at the reports on how the opioid epidemic, has got to be stopped and addressed.  I am, along with millions of other Americans, are on the other end of opioids. I am on the end of the chronic pain disease epidemic.   As the CDC, DEA and Medicaid and medicare,  and numerous other government associates, are blaming Doctors for the over prescribing of medication,  NOBODY, is looking at or reading the statistics from chronic pain disease patients.   How about not addressing these drugs as dangerous and addictive.  Lets look at them as lifesaving and medically necessary for the million of Americans in chronic pain.  Chronic pain is a disease.   It is now becoming an epidemic. No other disease medication is scrutinized.  Chronic pain is a disease.   We as patients are being denied,  dismissed and overlooked by our drs due to all the scrutiny associated with treating chronic pain disease.   Our doctors are afraid to treat us adequately.   We have a disease that medication is readily accessible to us and we are being denied.   We pain patients are truly being discriminated against, due to people who use heroin,  illegal fentanyl,  and placed a blame on anyone but themselves.   This is a witch hunt for drs who prescribe life saving medication and pain disease patients who benefit from this medication.  We have a chronic disease.  We want to be able to take care of our homes, our children,  our selves, as much as possible,  but without access to our, potentially, life saving medications,  we are unable to do so.  We want to live not just exist in pain 24/7.  We need the government agencies to look at the real statistics, not the hand picked.We need help.  With all the headlines, topics and stories on how opioids are bad, lets look at what good they do for our disease of chronic pain and the million of Americans they help. Comments provided by RADARS System The Association for Accessible Medicines (AAM) acknowledges the efforts of the Food and Drug Administration (FDA, or the Agency) on Docket Number FDA-2017-N-2903 regarding exploring present and future capabilities to evaluate the effectiveness of abuse deterrent opioids in the post market setting. As discussed further below, AAM commends the Agency for its ongoing efforts in mitigating the risk of misuse and abuse of prescription opioids, and offers several suggestions regarding this important public health issue.  This war on opioids is actually a war on  chronic incurable diseases.  A war on chronic pain disease patients who benefit from opioid medications.  Medications that enable millions of Americans relief of chronic debilitating pain associated with these diseases. The fiction, widespread hysteria and distorted truths about this opioid epidemic, is killing legitimate chronic pain disease patients who use their medications responsibly.  We are patients.100 million Americans have one or more chronic incurable pain Diseases.  As the CDC, DEA, FDA, Medicaid and Medicare,  and numerous other government agencies, are blaming Doctors for the over prescribing of opioid medication.  NOBODY, is looking at or reading the statistics from chronic pain disease patients.   How about NOT addressing these drugs as dangerous and addictive.  When all else fails: physical therapy, exercise, over the counter medications and numerous injections etc, we chronic pain disease patients, are left with one option to help us cope, opioid pain medication.   Lets address this medication as lifesaving and medically necessary for the million of Americans with chronic diseases. Chronic pain is a disease.   Chronic pain disease patients are now the epidemic.   The addiction rate of chronic pain disease patients is .02-.6 %.  We do not misuse or abuse our medications.No other disease medication is scrutinized.  We, as patients, are being denied,  dismissed, overlooked and discriminated against, by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications.   Our Drs are afraid to treat us humanely and adequately.   We have a disease that medication is readily accessible and beneficial to us and we are being denied.   We, pain patients, are being discriminated against, due to people who abuse illegal heroin and illegal fentanyl.  This is a direct hunt for Doctors who prescribe life saving medication, for pain disease patients, that benefit from them.  We have our privacy invaded, we no longer are able to have doctor/patient confidentiality.  We now have insurance agencies,  pharmacists, and other government agencies in our physicians offices, monitoring, prosecuting and policing our physicians. Though the statistics show a reduction in, opioid medications distributed, due to the CDC guidelines, death rates of overdoses from illegal opioids is rising.  The specific causes of deaths also needs to be closely investigated.  The opioid in the persons system needs to be specified.  Was it an illegal opioid,  was it opioid medication specifically for that person, was there other drugs or alcohol involved? These statistics need to come out.  These Government agencies do not want that information out, due to the fact that this opioid epidemic, would then be debunked.Lets put the shoe on the other foot.  Restricting or taking away our medications is like FORCING people who do not want this medication to take it.  One day those against these medications will need them but they will be denied.  We have a chronic disease.  We want to be able to take care of our homes, our children,  our selves, as much as possible,  but without access to these life saving medications,  we are unable to do so.  We want to live, not just exist in pain 24/7.  We need the government agencies to look at the real statistics, not the hand picked.  These agencies are not physicians.   They are trying to doctor us, patients, without a medical license.   They are also trying to police our physicians.  This is a war on a disease, medications, physicians and patients. We chronic pain disease patients need help.  All the headlines, topics and stories on how opioids are bad and how people are abusing, misusing, overdosing, becoming addicted or dying from them.  We need to look at the good they do and how they help our disease of chronic pain and the million of Americans who use them for some relief. The government needs to put the focus on illegal drugs coming into, being manufactured and distributed in this country, illegal fentanyl,  illegal heroin, methamphetamine, cocaine and all other ILLEGAL DRUGS.  Not the legally prescribed and medically necessary medications we patients need. We chronic pain disease patients need help, but we are helpless due to the government and government agencies. There is stigma, scrutiny and discrimination against us due to a category of medications we desperately need and benefit from, opioid medications. WE ARE PATIENTS NOT ADDICTS! !