“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
For more than 7 years Thomas Frieden, MD, MPH, led the CDC as it faced challenges including MERS, Ebola, and Zika as well as the growing opioid crisis, but on Friday he will step down as Donald Trump assumes the presidency. During his final hectic days in Atlanta, Frieden took time to share some thoughts about those tumultuous years with MedPage Today’s F. Perry Wilson, MD, in this exclusive video interview.
“When I went to medical school, I was told that if you give an opiate to a patient who has pain, they won’t get addicted — completely wrong,” Frieden told Wilson. “Opiates are highly addictive, and the therapeutic ratio is quite narrow, so if you give a little bit too much, you can die, and after just a few pills, you can be addicted for life … What we know is that for chronic pain, other modalities of treatment are much safer and can be at least as effective, and may even be more effective.”
As part of MedPage Today’s new “Doc to Doc” series, Wilson talked with Frieden about his proudest accomplishments during his tenure at the agency, the challenges still ahead, and what keeps him up at night.
McKesson gets their controlled med license suspended for THREE YEARS because the DEA “thinks” that they failed to report “suspicious pharmacy orders”…and just what is a “suspicious pharmacy order”… No proof if diversion of controlled meds, no deaths associated with this… just the DEA and their “opinions”.
Is this the rational behind the wholesalers “rationing” controls to pharmacies and if the pharmacy is out of stock for a pt with a medically necessary/legit/on time prescription… must be just “collateral damage” for the pts having to go thru cold turkey withdrawal ? Of course, the DEA denies that they have caused wholesalers to ration controls to pharmacies. Guess who is going to end up on the short end of the stick as a reaction to this huge fine of Mc Kesson ?
Drug distributor McKesson Corp., a supplier to U.S. pharmacies, is paying $150 million and stopping prescription drugs sales from its Aurora distribution center to settle allegations that it avoided reporting suspicious pharmacy orders in Colorado and other states.
The $150 million payment by the San Francisco-based company is a record for settling an alleged violation of the federal Controlled Substances Act.
Federal authorities say McKesson, a major distributor of drugs and medical devices, didn’t adhere to requirements for monitoring pharmacies’ orders of prescription drugs over several years, despite having settled similar allegations and paying $13.25 million in civil penalties in 2008, the U.S. Department of Justice said Tuesday.
“When drug distributors like McKesson fail to alert the [U.S. Drug Enforcement Agency] of suspicious orders of prescription drugs by pharmacies, the end result can be fatal,” said Bob Troyer, acting U.S. Attorney for Colorado. “This settlement requires McKesson to comply with the law and holds the company accountable for its past conduct. Avoiding that legal obligation increases the narcotics street trade.”
McKesson also agreed to suspend sales of controlled substances from its distribution centers in Colorado, Ohio, Michigan and Florida under the settlement agreement.
The distribution center suspension in Colorado will last three years, the company said. The center will continue to distribute over-the-counter drugs and non-controlled substances; no job losses are anticipated as a result of the suspension, McKesson said.
According to prosecutors, McKesson supplied pharmacies an increasing amount of oxycodone and hydrocodone between 2008 and 2013, and the misuse of the two drugs are part of the rise in opioid drug abuse that’s become so pervasive it’s been deemed a national crisis.
McKesson’s distribution center in Aurora “circumvented its own compliance system in order to avoid reporting suspicious orders to the DEA,” prosecutors said. The company was supposed to set thresholds for what pharmacies could order each month, but sometimes failed to do so or increased the thresholds at the request of the pharmacies, avoiding having to report ordering activity to the DEA, prosecutors said.
In other instances, drug-order thresholds were set so high that a pharmacy could never reach it, and as a result the pharmacies wouldn’t be scrutinized for orders of unusual size or frequency or other suspicious activity, prosecutors said.
McKesson has increased its internal safeguards since 2013, when it began settlement negotiations with the DEA and justice department, the company said.
“Pharmaceutical distributors play an important role in identifying and combating prescription drug diversion and abuse. McKesson, as one of the nation’s largest distributors, takes our role seriously,” said John Hammergren, McKesson chairman and CEO.
McKesson agreed to tighter internal controls for the next five years as part of the settlement and will bring on an independent monitor to watch its compliance with the settlement agreement. Such independent monitoring is a first for a civil settlement of this sort, prosecutors said.
“This agreement demonstrates that DEA will continue to hold all those accountable – corporations and individuals – who would disregard the public’s safety for their own profit,” said Barbra Roach, special agent in charge at the DEA Denver division.
U.S. Attorneys Office prosecutors in Colorado and the Northern District of West Virginia, along with DEA lawyers, led the settlement negotiations with McKesson. DEA field office investigators and federal prosecutors in 14 other states were involved in investigating the case leading to the settlement announced Tuesday.
UnitedHealth Group Inc. reported a 56 percent increase in profit in the fourth quarter of 2016, driven by continued growth of its health services business and a nearly 16 percent increase in revenue from premiums.
The Minnesota-based company reported a fourth quarter profit of $1.9 billion, or $1.96 diluted earnings per share, compared with $1.2 billion in the year-ago period. Earnings per share adjusted for acquisition-related expenses came to $2.11, four cents above analysts’ expectation of $2.07.
UnitedHealth added more than two million medical members in the fiscal year, which helped drive the increase in premiums in the final quarter.
“The market has been stable with strengthening employment rates helping us grow within existing customers,” David Wichmann, president, said in a conference call with investors.
The company’s Optum pharmaceutical and pharmacy benefit management units drove revenue growth and improved operating margins, said Ana Gupte, an analyst for Leerink, in a research note. The quarterly results are a “good set-up for 2017,” Gupte said.
Graph of UnitedHealth net earnings from 2012 to 2016 (Rachel Newman/MEDILL)
In January, UnitedHealth announced that it will acquire Deerfield, Ill.-based Surgical Care Affiliates for $2.3 billion. The company operates 205 outpatient surgical facilitates across the country.
SCA will be added to the company’s Optum business, which seeks to grow its ambulatory care portfolio, Renfro said in a conference call with investors.
Strategic partnerships with Walgreens Boots Alliance Inc., CVS Health Corp. and AllScripts Healthcare Solutions Inc., as well as new contracts with the Department of Veterans Affairs, contributed to Optum’s revenue growth, said Optum CEO Larry Renfro in the conference call.
UnitedHealth expects to take a $350 million operating charge in 2017 due to the liquidation of Penn Treaty American Corp., a financially distressed long-term care insurer based in Pennsylvania.
Though the company is not affiliated with Penn Treaty, state laws require that health insurers be assessed a share of the funds needed to protect Penn Treaty policy holders, Wichmann said.
UnitedHealth’s earnings report comes amid political uncertainty about the future of the Affordable Care Act. Last spring, the company announced that it would pull out of many state Obamacare exchanges, including the exchange in Illinois.
In a conference call with investors, CEO Steve Hemsley spoke in favor of “robust state-based health care markets” as well as “flexible Medicaid available to eligible as well as paying beneficiaries” and “well-structured and managed high risk pools.”
Following the earnings release UnitedHealth stock fell 2.5 percent and then rebounded to $160.66 per share at the close of trading, down 0.7 percent from Friday’s close.
Out of the top TWENTY prescriptions for medications… there was only THREE that had fewer prescriptions between 2011 and 2015 .. with Hydrocodone/APAP products showing the LARGEST DROP. While the overall number of prescriptions for “pain medications” remained MOSTLY UNCHANGED. Tramadol increased 26% and only THREE controlled medications were in the TOP TWENTY. (Hydrocodone/APAP, Tramadol, Alprazolam)
Significant therapeutic advances that can help combat or cure life-threatening diseases have been made in the last few years. However, achieving a delicate balance between accessibility and affordability in the era of costly treatments poses a challenge.
A report unveiled by the IMS Institute for Healthcare Informatics highlights aspects of medication use and spending (Table1). According to the report, total spending on medications in the U.S. reached $310 billion in 2015, an 8.5% jump from the previous year. Major factors fueling growth included new branded products, generic spending, and expired patents.
New brands available for less than 2 years, notably specialty medicines, accounted for over half of the total spending growth. New brand spending increased by $24 billion, primarily driven by new hepatitis C treatments, such as ledipasvir/sofosbuvir (Harvoni, Gilead). Other specialty drugs steering growth include an easier dosing option for multiple sclerosis, a combination therapy for HIV, and treatments for autoimmune conditions and cancer. Traditional medicines, including SGLT2 inhibitors targeting diabetes and a new human papilloma virus vaccine, contributed 33% to new brand spending growth (see Drugs that are driving growth).
Table 2 shows the top 20 prescribed medications in the U.S. according to IMS health.
The IMS report also cites that generic spending increased by 7.4% —$7.9 billion—fueled by the availability of aripiprazole (Abilify, Otsuka), esomeprazole (Nexium, AstraZeneca), and celecoxib (Celebrex, Pfizer) generics. Branded generics, non-original medicines marketed with trade names, grew sharply on an invoice price basis.
IMS Health has not released a 2016 prescription drug spending report yet. In 2015, spending on oncology drugs increased 18% –to $39 billion: targeted therapies, such as monoclonal antibodies and protein kinase inhibitors, took the lead. These agents have shown efficacy against various tumor types by targeting gene mutations in cancer cells, while minimizing impact to surrounding healthy cells. Monoclonal antibodies accounted for 35% of total spending, driven both by novel PD-1inhibitors and existing treatments. PD-1 inhibitors target immune checkpoints and act as an “off switch” that helps to keep T-cells from attacking other cells. The agents have demonstrated efficacy against many tumor types, including melanoma and hepatocellular carcinoma. Current game-changers, pembrolizumab (Keytruda, Merck) and nivolumab (Opdivo, Bristol-Myers Squibb), are undergoing more than 135 clinical trials for additional indications. The 27% increased spending on protein kinase inhibitors was mainly due to the recent approvals of palbociclib (Ibrance, Pfizer) and ibrutinib (Imbruvica, Janssen Biotech).
According to the IMS report, spending on diabetes medications also increased by 8.2% on a net basis in 2015, compared with 30.1% growth on an invoice basis. Insulins accounted for nearly half of the $10 billion invoice price growth; however, all of the increase was offset by rebates and price concessions. Additionally, invoice spending on DPP-IV inhibitors, SGLT2s, and GLP-1 agonists rose steadily.
Several new active substances (NAS) and non-NAS were also unleashed. NAS refers to a new molecular entity, new biologic agent, or a new combination drug in which at least one element is new. Oncology, infection, and neurological disorders were the most prevalent therapeutic areas, and account for majority of NAS launches in recent years. About a third of the NAS launched in 2015 had a FDA orphan designation, while the number of non-orphan drugs approvals was at its highest since tracking began in 2002. Approximately two-thirds of all orphan drugs were for oncology indications, while the rest targeted rare diseases, such as cystic fibrosis and hemophilia B.
Prominent non-NAS launches include rare disease treatments, and options offering improvements that address patient adherence and unmet needs. Five additional therapies for diabetic patients are now available, including the first inhaled insulin and options providing easier insulin administration. New HIV treatments were also unveiled, providing options against drug resistance and reduced pill burden.
The IMS report revealed that developments in biosimilars remain at high levels, with its first U.S. approval in 2015 and a growing pipeline on the horizon. Sandoz launched Zarxio (filgrastim-sndz), the first biosimilar approved via the biosimilar pathway, in August 2015. The first non-original biologics, Granix and Omnitrope, were previously approved through alternative FDA pathways. According to Ralph Boccia,MD, Medical Director of the Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION), “while biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general. Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies.” Seven biosimilar applications were pending via the FDA biosimilar pathway at the end of 2015, and others with The Prescription Drug User Fee Act (PDUFA) dates in 2016.
Pipeline Drugs and Future predictions
In November 2016, Mylan and Biocon announced the submission of a Biologics License Application (BLA) to the FDA for MYL-1410, the proposed biosimilar to traztuzumab (Herceptin, Genentech).
The investigational quinolone antibiotic, delafloxacin (Baxdela, Melinta Therapeutics), is being evaluated for the treatment of skin infections and community-acquired bacterial pneumonia. The drug has broad-spectrum activity, most notably against MRSA. Key advantages of the drug include no dose adjustment or monitoring requirements in obese patients, according to a phase 3 study presented at IDWeek 2015 in San Diego, CA.
Genentech’s anti PD-L1 cancer immunotherapy, Tecentriq (atezolizumab), received FDA approval for bladder cancer recently, and is set to be one of the best selling drugs in 2022, according to a report released by EvaluatePharma. Roche’s multiple sclerosis therapy, Ocrevus, and hemophilia drug, emicizumab, are projected to be potential blockbusters and have helped the pharma company claim the crown for the highest valued pipeline.
Monica Shah, PharmD is a Clinical Pharmacist at RWJ Barnabas Health in New Jersey and adjunct faculty member at Ernest Mario School of Pharmacy at Rutgers University.
I have talked to… exchanged emails with… read chronic pain pts statements that they have contacted law firms to sue some healthcare provider for cutting their opiates, discharging them for no – or trumped up – reasons.
And without exception, the law firms have replied NOT INTERESTED !!!!
The truth of the matter is that in our legal system… the “value” of the life of a handicapped/disabled, elderly, unemployable person is NEAR ZERO… because these people are considered “takers” as opposed to “makers” within our society.
No potential future earnings… no “value of life”. Likewise, in suing a individual healthcare provider they can use the defense of “it was my professional opinion” as to the treatment needed by the pt’s and their medical issues.
Now that we have large medical practices and large corporations (hospitals) that are the employers of prescribers and these entities are making decisions on the limitations of mgs/day of opiates that their employed prescribers can provide to ALL PTS… then we have two interesting concepts… first of all the corporation – or collusion of partners within a large group practice – attempting to practice medicine by some “cookie cutter edict”. Secondly, they are professing that they are implementing the CDC opiate guidelines.. when in fact they are implementing selected portions of the guidelines and not the guidelines in their entirety… so they are lying about their policies.
IMO… while suing individual healthcare providers, they can claim that they are using their “professional discretion” in determining a individualized pt therapy/treatment.
These large practices or hospitals typically have VERY DEEP POCKETS and their treatment edicts are causing hundreds or thousands of pts having their quality of life adversely affected.
Here is four quotes from the CDC opiates guidelines:
“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”
“Clinicians should consider the circumstances and unique needs of each patient when providing care.”
“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”
“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”
All of these changes, has probably changed the entire equation for law firms. I have put a link at the top of this post of the major CLASS ACTION LAW FIRMS. If your are seeing a prescriber – particularly one who is an employee of a larger practice or part of a hospital system – and your opiate dosing has been lessened – because they are following the CDC guideline – and it has adversely affected your quality of life… Then it may be in your best interest to contact one or more of the above listed class action law firms… the more people that contact them…the more likely that the chronic pain community can get their attention. It has been less than one year since the CDC guidelines have been published… the number of practices that are adopting these guidelines as their practice’s policy is growing… in all likelihood … if they have not impacted your quality of life yet.. it is just a matter of time before they do.
Until now the prescribers and their employers have only had to fear the DEA and their Hippocratic oath of “doing no harm”… now applied to their own license and financial well being. Several class action law suits could change their focal point of fear to from the DEA to the patients.
These various entities represents a lot of “DEEP POCKETS” to law firms that specialize in class action lawsuits. Remember you are not talking about really suing the prescriber that have reduced your medication… you will be suing their EMPLOYER who has dictated this change in your medically necessary medication and your quality of life.
As a final thought… if you are reading this… and regardless if you are being affected right now or not… Does not mean that you will be affected within the next 6-12 months.. I suggest that you share this across web far and wide… more and more pts are being adversely effected.
On Boxing Day, Geoff Moses will run out of the oxycodone pills that have controlled his chronic pain over the past three years, allowing him to work and have a life.
Once that last pill is gone, his pain will intensify and the 41-year-old employment counsellor will begin an ugly, slow withdrawal.
Like thousands of others, Moses is collateral damage in a North American-wide opioid epidemic that has sparked the fentanyl crisis.
Opioid prescriptions in North America is more than six times higher per capita than prescription rates in Europe. In Canada, opioid prescriptions rose to 25.7 million in 2014 from 17.5 million in 2010, while in the United States, it spiked 500 per cent between 2000 and 2011.
For the past three years, Moses has been strictly following his doctor’s orders that have included agreeing to drug testing to ensure that Moses is taking, not selling, his oxycodone.
Last summer, the College of Physicians and Surgeons of British Columbia enacted opioid prescribing guidelines. And in November, it sent a letter to Dr. Andre Hugo.
Hugo immediately began tapering Moses off codeine (Tylenol 3). And, in a letter dated Nov. 18, Hugo explained that Moses’s oxycodone dosage would also have to be cut back.
“As a result of the recent narcotic and fentanyl crisis in British Columbia, the newest ceiling dose for narcotics is 90 mg of morphine equivalent per day as per the College of Physicians and Surgeons [of B.C.],” Hugo wrote. “Your current morphine equivalent dose is 135 mg.”
That he said, “does not comply with the new ceiling dose of the College; guidelines which are being strictly enforced … with consequences to the detriment of physicians who do not demonstrate compliance.”
Hugo wrote that he was willing to “facilitate tapering your narcotic dose to below that ceiling dose.” But if Moses wanted to continue his current drug regimen, “I strongly urge you to obtain the services of another physician as soon as possible.”
(Hugo declined to be interviewed, but his office confirmed that the letter was given to Moses.)
Prescription pills containing oxycodone and acetaminophen are shown in this June 20, 2012 photo. Graeme Roy / THE CANADIAN PRESS
“I’m desperate,” Moses said in an interview. “But I’m not prepared to drop this.”
Reluctantly, late last week he filed a complaint against Hugo with the College even though he remains a supporter of the doctor, whom he calls an ally.
But Moses is already suffering from the codeine withdrawal that’s left him in so much pain that for the past two weeks, he hasn’t been able to work.
He loves his job, helping disabled and older people find work.
“If I could have created a job that’s perfect for me, this would be it,” he said.
“The thought of medical retirement — something I’ve fought constantly — is a now a very strong possibility.”
As Moses said, “You can look at me and know I’m going to hurt.”
He was born with spina bifida and has a spine “like a frozen sack of peas.” He uses forearm crutches to get around because of a leg amputation.
Still, until he was diagnosed with spinal stenosis, it was a point of pride for Moses that he controlled his pain with Tylenol 3 — a prescription that began when he injured his knee skiing.
The spina bifida makes the spinal stenosis inoperable and the three bone spurs have caused nerve damage in his hands and cause chronic, “very significant, sharp pain.”
To deal with that pain, Moses was prescribed OxyContin and, more recently, the time-release, OxyNEO.
The College doesn’t comment on specific cases. But, deputy registrar Ailve McNestry said the guidelines are only guidelines, not ceilings. She emphasized that letters sent to doctors who breach the guidelines are meant to be educational, not disciplinary.
“No doctor in B.C. has ever lost his licence for prescribing practices,” she added.
Beyond filing a complaint with the college, what should Moses do? I asked both McNestry and Doctors of B.C.
Get a new doctor, both said. Try a walk-in clinic. Go to the hospital.
But, despite Premier Christy Clark’s promise that by 2015 every British Columbian would have a GP, there remains a critical shortage of doctors.
In Kelowna, the Walk-in Clinics of B.C. Association said another 35 family doctors are needed for the estimated 40,000 people who haven’t got one.
Two weeks ago, Moses thought he’d found a new doctor. But he was refused as a patient after answering yes to the first question: Are you on an opiate plan?
He was referred to and rejected by the addictions clinic. It’s staffed by psychiatrists and mental health experts, not chronic pain specialists.
As for walk-in clinics, one Okanagan clinic closed this summer and another is closing in early 2017.
So what options is Moses left with? Enforced withdrawal. Street drugs, which he’s adamant he won’t risk because of the fentanyl deaths. Or, experimenting at the local (illegal) cannabis shop.
What kind of choices are those? And with all the attention focused on the fentanyl overdoses and deaths in the street, who’s looking out for people like Moses?
The number of opioid prescription reimbursements fell dramatically in one of the largest health insurance networks in the region in late 2016, suggesting efforts to cut widespread abuse may be working.
The decline reported by Highmark in September, October and November coincided with the launch of the state’s new prescription drug monitoring program, which lets doctors see if a patient has gotten prescription painkillers or other potentially addictive drugs from other physicians.
From January through August, Highmark said, the number of reimbursements each month ranged from 118,261 to 110,045. From September through November, they ranged from 107,477 to 107,843. December numbers are not yet available.
Other insurers have also reported change in opioid prescriptions, with Capital BlueCross saying it has seen “a small but continued decrease,” and UPMC Health Plan telling the Pittsburgh Post-Gazette that 16 percent of its members received at least one opioid prescription in 2016, down from 20 percent in 2015.
Dr. Lauren Hughes, the Pennsylvania Department of Health’s deputy secretary for health innovation, said it’s too soon to say whether the declines are because of the new program.
But, she said, it is clear that both in Pennsylvania and nationwide, awareness is growing.
“What we’re attempting to do here is create a cultural change on how to more safely prescribe,” she said, noting that the state boards of medicine and pharmacy published new opioid guidelines this summer. “It’s going to take a lot of effort for a long while for us to get there.”
So far, so good
To date, Hughes said, the new monitoring program has been going well, fielding about 2.3 million queries.
“That’s 2.3 million times that prescribers are asking to see data to make more informed decisions,” she said. “We’ve been very pleased with the progress so far.”
Hughes noted that although the monitoring program was initially voluntary, a law passed in the fall made it mandatory for opioid prescriptions starting Jan. 1.
Prior to the program’s rollout, some providers expressed concern that more scrutiny on opioid prescriptions might push more patients to illegal drugs like heroin.
Department spokeswoman April L. Hutcheson said it doesn’t have information on that, but that the big-picture goal of the program is to identify people who might have an opioid problem early and help get them into treatment.
“If you need it, your doctor is going to prescribe it,” she said. “It’s not preventing opioids from being prescribed; it’s giving prescribers the big picture as to where people are getting their prescriptions from.”
In addition to the state’s efforts, insurers, health systems, insurers and employers are also taking steps to address the problem of opioid abuse.
Patrick Stewart, president and CEO of Pittsburgh-based Innovu, said it is performing opioid analysis “for almost all of our clients on a monthly or quarterly basis.”
The company, which helps employers assess health data, recently announced a partnership with The Business Group on Health, an independent affiliate of The Lancaster Chamber of Commerce & Industry.
Stewart said he thinks the new opioid guidelines are having an effect by now, and that many insurers are making changes as well.
For instance, Highmark recently added pharmacists to its care management teams that help members who have multiple health issues. It said their role will involve “evaluating individual cases and advising the team on the safest, most effective therapies.”
The hemp industry has taken the DEA to court in the wake of a controversial new rule on marijuana extracts.
Denver’s Hoban Law Group, representing the Hemp Industries Association, Centuria Natural Foods and RMH Holdings LLC, on Friday filed a judicial review action against the U.S. Drug Enforcement Administration, alleging the agency overstepped its bounds when enacting a rule establishing coding for marijuana derivatives such as cannabidiol (CBD) oil. The action, Hoban attorneys allege, puts at risk a booming cannabis and hemp industry and a wide variety of hemp-based products currently on the market.
“We’re talking about jobs and the economy and agricultural (revival),” attorney Bob Hoban said in an interview with The Cannabist on Friday.
The DEA last month confounded many in the cannabis industry with the filing of a final rule notice establishing a Controlled Substances Code Number for “marihuana extract,” and subsequently maintaining marijuana, hemp and their derivatives as Schedule I substances.
DEA officials said the code number would assist in the tracking of materials for research and would aid in complying with treaty provisions. However, compliance attorney Hoban and others expressed concern at the time that the language could result in federal agencies viewing products produced from marijuana and hemp as illegal.
The rule was set to take effect Friday — the same day Hoban filed suit in the U.S. Court of Appeals for the 9th Circuit in San Francisco.
Hoban’s petition seeks a judicial review of the final rule on the basis that the action was inconsistent with the law — including the U.S. Controlled Substances Act and the Agricultural Act of 2014, or the Farm Bill — and effectively amounts to a scheduling action.
A scheduling action, Hoban said, would need congressional approval.
According to the lawsuit:
“Additionally, the final rule creates this new drug code, indicative of being a controlled substance, for substances which are in fact not controlled pursuant to the (Controlled Substances Act),” Hoban attorneys wrote in the lawsuit. “Specifically, the final rule dictates that the mere presence of ‘cannabinoids,’ which are not controlled substances, is the determinative factor of whether a compound is a ‘marihuana extract.’
“Further, the final rule overbroadly defines ‘marihuana extract,’ without reflecting that certain portions and varieties of the genus Cannabis sativa L. are congressionally exempted from the CSA and/or are exempted from being treated as controlled substances altogether pursuant to the relevant laws, as enacted by Congress.”
Hoban said Friday that his firm also intends to file an administrative petition next week with the DEA, formally requesting the administration to rescind the definition.
“(The new rule) certainly has caused quite a chill in the marketplace over the last three or four weeks,” Hoban said, adding that he’s heard from producers who have had trouble keeping their products on e-commerce or retailer platforms. “The number of calls we get on a daily basis, you couldn’t even quantify. … That is indicative to me of an environment where people are scared, they’re nervous.”
Hoban said he does not expect a spike in enforcement — especially as long as spending bill provisions stay in place — but he encouraged producers to maintain strict processes and to conduct an audit of their businesses to ensure that they are in compliance with state and federal regulations.
DEA spokesman Russ Baer said he could not comment on a petition that he has not yet seen.
Earlier Friday, Baer addressed the agency’s positions on CBDs, marijuana and hemp extracts in an e-mail:
CBD oil and other extracts derived from cannabis (which includes hemp) have been and will continue to be Schedule I controlled substances, unless and until they are determined to have a current accepted medical use. We need conclusive scientific evidence to make these determinations and the lack of evidence regarding the efficacy of cannabis is impressive. To handle any controlled substance, an entity or individual must be a DEA registrant to be authorized to conduct research with the particular controlled substance.
Under U.S. law (the CSA), the definition of marijuana includes all parts the cannabis plant that are the source of cannabinoids. The CSA definition of marijuana also includes “every compound, manufacture, salt, derivative, mixture, or preparation” of such parts of the cannabis plant – and CBD produced from the cannabis plant clearly falls within this category. Thus, CBD, being a derivative of marijuana, is marijuana under U.S. law (and hemp is marijuana). Accordingly, because marijuana is a schedule I controlled substance under the CSA (as set forth in 21 U.S.C. § 812(c), Schedule I(c)(10)), CBD is a schedule I controlled substance under the CSA.
And as for hemp, specifically:
The Farm Bill did not remove industrial hemp from the list of controlled substances and, with certain limited exceptions, the requirements of the Federal Food, Drug, and Cosmetic Act and the CSA continue to apply to industrial hemp-related activities, nor did it change the requirements of the CSA that apply to the manufacture, distribution, and dispensing of drug products containing controlled substances.
DEA cannot provide an exhaustive list of “hemp” products that are exempted from control. Nonetheless, in order to provide clarity to your question, the following are some of the more common “hemp” products that are exempted (non-controlled), provided they are not used, or intended for use, for human consumption: paper, rope, and clothing made from fiber derived from cannabis stalks, industrial solvents made with oil from cannabis seeds, and bird seed containing sterilized cannabis seed mixed with seeds from other plants (or other ingredients not derived from the cannabis plant). Personal care products (such as lotions and shampoos) made with oil from cannabis seeds are also generally exempted.
John Hudak, deputy director of the Center for Effective Public Management and a senior fellow at the Brookings Institution, said earlier this week that the extracts rule was not a change in policy but rather “a clarification for an industry that for a long time has misinterpreted policy.”
The biggest challenge is that marijuana laws have become a “telephone game” in which rumors, guesses or ideas are translated from one person to another to the point where they’re viewed as facts, he said.
As Baer stated Friday: “DEA has consistently opined that marijuana and its constituent parts or derivatives, including CBD and hemp, are Schedule I controlled substances – so these determinations are deeply rooted in the CSA and not new.”
And that was the case with extracts.
Products such as CBD oil were regarded as not subject to the same control requirements as marijuana and extracts could cross state lines and international waters without issue.
“The government was aware of this and issued (the final rule notice),” Hudak said, adding that officials effectively conveyed, “‘Listen, you have misinterpreted our laws regarding CBD and you have one month to become compliant.”
Cannabis is under strict regulations of DEA and prejudice from NIDA despite eighteen states issuing permission to medical cannabis. Scientists are facing numerous difficulties in carrying researches to find out the potential benefits of the drug. Other restricted compounds like MDMA, psilocybin or LSD are more easily available for further researches as DEA has allowed growing them or creating them in the lab.
Marijuana’s unrevealed valuable components that can be used in life-saving drugs are still out of reach of man. The pot is available for recreational uses and the public is having no big deal in obtaining it, reports Popular Science.
Treating illness by cannabis is just a few steps away if the schedule 1 study is reclassified. With an easy access to marijuana, the studies can be expanded and more data can be gathered in a short time. Now when marijuana is more widely accepted, the 16 member committee releases a report with recommendations to a smooth supply of cannabis for research purposes.
Since marijuana is classified as a medicine, then its study as a helpful medicine must be much wider, said pharmacologist Karen Wright of Lancaster University in England. There are more questions than answers about the mental and physical influences of cannabis on the health. The little data that is available about the drug has strong indications that the potential of marijuana to treat ailments and sickness is much higher than expected.
Cannabinoids is proved to be effective for the treatment of chronic pains, chemotherapy-induced nausea and vomiting in adults, reports Science News. A lot of essential investment on marijuana remains illegal because the drug is a linchpin in the War on Drugs, comments Brad Burge, the director of communications for the Multidisciplinary Association of Psychedelic Research (MAPS).
National Institute on Drug Abuse has taken a biased stance towards cannabis. It allows the growth of cannabis and researches on the drug only to prove its negative effects in order to control the substance and prohibit drug abuse but it is not interested to help establishing cannabis as a medicine drug.
