Request that the FDA ensure follow on products citing BUTRANS as the reference listed drug are as safe and effective as BUTRANS. CLOSED
Citizen Petition CDER Kleinfeld Kaplan & Becker, LLP BUTRANS buprenorphine reference listed drug Purdue Pharma L. P. CLOSED
2017-07-21
FDA-2017-P-1911-0004
04:00:00
https://api.regulations.gov/v4/comments/FDA-2017-P-1911-0004
Anonymous
Anonymous
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, ethically 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. 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! !