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Opioid Rescheduling Mitigation Act


Steven Andrews

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A BILL

To Mitigate the Effects of the 2014 Rescheduling of Opiate-based Medications

SECTION 1. SHORT TITLE
1. This bill shall be known as the Opioid Rescheduling Mitigation Act.

SECTION 2. Sense of the Congress
1. The Safe Prescribing Act of 2013, which provided for rescheduling hydrocodone-containing drugs from Schedule III to Schedule II, was grounded in a need to prevent an increasing dependence on opioids.
2. Under the Schedule III regime of regulation for opioid-based medications, many such drugs were aggressively marketed to and prescribed to patients, resulting in a number of the patients in question becoming chemically addicted under legal prescriptions.
3. While the Safe Prescribing Act of 2013 was grounded in the need to prevent these addictions, given the nature of the opiods in question the decision to reschedule the drugs in question without the provision of alternatives or provision of funding to assist persons already chemically addicted to the drugs in question has driven tens of thousands of people to seek out other, more dangerous drugs.
4. In some instances where dependence was long-developed under the previous Schedule III regime, due to various individual biological factors the physical or chemical dependence of some patients on the drug(s) in question may be difficult or impossible to break.  In other cases, the dependence may be based on a combination of physical/chemical addiction and persistent pain from injuries.
5.  The Congress notes that while the aforementioned addiction is an undesirable outcome, it also notes individuals can, in spite of the aforementioned addiction, continue to be productive members of society with proper medical monitoring; but the chances of such an outcome drop dramatically if the individual is forced to rely on illegal sources for their medication.

SECTION 3. Mitigation of Opioid Rescheduling Effects
1. In the event that a doctor diagnoses a patient with an addiction to opioid-based medication on the basis of current of former legal prescriptions, the doctor in question may refer the patient in question to another doctor to resume their previous prescription so long as the resumed prescription is accompanied by treatment to attempt to mitigate or resolve the addiction in question.
2. The FDA shall make provision to permit a patient who, following not less than one year of efforts to resolve their addiction, shows little or no progress to request a permanent exemption for their prescriptions following a review of their case by a panel of not less than three doctors.
3. All diagnoses indicated in Section 3(1) of this Act shall be subject to external review by a competent medical authority, and shall be audited by the FDA.  State medical authorities shall be advised to take reasonable steps to prevent the resale of prescribed medication provided under this Act.
4. Any patient who receives a diagnosis under Section 3(1) or 3(2) of this Act shall, if subsequently found guilty of the illegal sale or distribution of their medication, lose that exemption.

SECTION 4. Effect
This Act shall take effect 90 days following lawful passage.

PES: Permits doctors to re-prescribe opiate-based medication to patients who became addicted under the pre-2014 Schedule III regime surrounding hydrocodone, so long as a simultaneous effort is made to wean the patients in question off the drugs.  Also permits patients who cannot be weaned off of the drugs in question after a year of efforts to apply for a permanent exemption to the Schedule II status of their prescription.

Andrew Byrd (and family), Virginia

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Mr. President,

This bill is limited in scope but it provides a way to addressing a key portion of the opioid crisis. Far too many people were led into addiction by a flawed medical establishment only for the government to throw them under the bus in a hasty, well-meaning but ill-conceived push to fix the problems that led to their addiction. The efforts had the best of intentions; they simply forgot that the law can't always tell peoples' bodies how to deal with chemicals. As a result, the crisis was made worse as people who didn't have the support needed to get off these drugs...if they can, given both the strength of the relevant addictions and the underlying condition that were being treated...were forced to turn to the street.  This bill will rectify that particular error. 

Therefore, I request unanimous consent to pass this bill.

 

I yield. 

Andrew Byrd (and family), Virginia

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Mr. President,
I will consider that amendment to be friendly and would happily encourage whatever we can do to cut the relevant gordian knots to adopt it.  As a sincere question to my colleague, does he wish to change anything else in the bill?  I'm pretty sure we're conceptually on the same page, so I'm down for improvements he might have handy, or for passing this bill and working up a bipartisan follow-up bill.

I yield.

Andrew Byrd (and family), Virginia

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Mr. President,

Me and the gentleman from Utah are on the same page and seeing as the amendment has been accepted as Friendly, I move for UC once more and I would like to join the gentleman in writing further legislation to stop this crisis.

I yield

William C. Motter D-CO-02 (Boulder, Fort Collins, Broomfield)

 

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Mr. President-

I object to UC. 

I offer the following amendment:

Section X. Safe Alternative for Opioids 

1. Amending the Controlled Substances Act (21 U.S.C. 812) —

a) To allow for the use of medically prescribed marijuana to treat illness.

b) To allow for the creation of legal dispensaries of medical marijuana.   

 

I yield

 

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Mr. President,

If I may ask sincerely, does marijuana tend to be used for the same purposes as hydrocodone and similar medications?  More to the point, does marijuana act as a substitute for opioids?

Regardless, I think I'm going to have to request a roll call vote; to do so would be disingenuous to a number of my colleagues.  I think we should also consider the question of prescription mills with respect to marijuana...but that is a broader problem.  Please give me a short bit and I'll draft some language to approach that particular angle on all pain relief medication.

Might I propose, for the sake of clarification, that we legislatively down-schedule marijuana strains and derivatives deemed to lack either serious dependence risks or concerns about psychological complications into Schedule III?  I think doing that and letting the FDA go from there would be safer, since in some respects 'marijuana' is a broad class of strains, all of which have different properties.  Would my colleague be amenable to such a change to his amendment?

I yield.

Andrew Byrd (and family), Virginia

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Mr. President,
As a substitute for my colleague's amendment, I propose the following language:
 

Section X. Safe Alternative for Opioids 

1. Amending the Controlled Substances Act (21 U.S.C. 812) —a) To direct the FDA to re-schedule marijuana strains and derivatives deemed as lacking either serious dependence risks or concerns about psychological complications into Schedule III of the Controlled Substances Act, and those strains and derivatives deemed as having significant concerns about psychological complications or dependence risks as Schedule II.

b) To allow for the creation of legal dispensaries of medical marijuana.

c) To direct the FDA to audit prescriptions from doctors whose primary practice consists of evaluating and prescribing marijuana or related products or derivatives for the appropriateness of such prescriptions, and to refer doctors found to be making significant numbers of excessive, lax, or unwarranted prescriptions to the relevant state medical authorities for action.

d) To direct that states should include marijuana and its derivatives on their prescription drug monitoring programmes.

===== ===== ===== ===== =====

This should give the FDA a bit more guidance, and also allow for cracking down on the concerning trend of "pot doctors" who have popped up in states where medical marijuana has been legalized.  At least with marijuana, I don't think we have the same dependence issues to worry about if prescriptions get cut off.

Andrew Byrd (and family), Virginia

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Mr. President,
As I promised earlier, I also propose a second amendment as follows:

Section X. Prescription Mill Prevention

1. Prescription Monitoring Programs

a) All states which receive funding for Medicare shall establish and maintain a prescription monitoring program which shall meet standards established by the Food and Drug Administration (FDA).  These programs shall be required to exchange information with one another and with the FDA.  These programs shall be funded as part of the states' Medicare funding, and shall have the same proportion of costs covered as Medicare covers.

b) The FDA shall monitor and audit the records created in the program created in this section for patterns of excessive or abusive prescriptions of drugs, with special attention to be given to those found to be addictive as well as medications with significant known risks for psychological side-effects.  The FDA shall have the power to subpoena such records as are necessary to carry out this task, and to refer cases of bad practices to the relevant state authorities for disciplinary action and/or prosecution.

c) The FDA shall also, in cases where a doctor has been found to be carrying out the excessive prescription of drugs with significant dependency risks or major withdrawal concerns, have the power to direct that the state(s) in question provide for the continuation of prescriptions of dependent patients until they can be safely withdrawn from such prescriptions.  They shall direct that the state(s) in question take steps to avoid sudden disruptions in their prescriptions, except in cases of suspected or demonstrated improper distribution by said patients or the forging of prescriptions, and may issue regulations to this effect.

===== ===== ===== ===== =====

And this gets to the other side of the issue I mentioned earlier.  We started out dealing with opioids, but this gets into abuses of psychiatric medication that I think have also become painfully common.

Andrew Byrd (and family), Virginia

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Mr. President,

i rise to thank the gentleman opposite for his amendment. The Opioid crises is not just one of heroin. The victims of it many times are just good people who have been prescribed something that their bodies can not handle. Medical marijuana is a far safer alternative many times over hydrocodone. Thousands die every year from these drugs when medicinal marijuana would alleviate their pain. My family thanks him, and I thank him. I will very proudly support his amendments and urge each and every member here to do the same. 

i yield.  

Calvin Ward

Senator Massachusetts- D 

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