Is the DEA Overreaching Its Authority?

By Lynn Webster, MD, PNN Columnist 

The U.S. Department of Justice (DOJ) does not have the legal authority to determine which health care activities constitute a “legitimate medical purpose.” However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of federal law.

In 1970, Congress passed and President Nixon signed into law the Controlled Substances Act (CSA). In its broadest sense, the CSA regulates every aspect of controlled substances, from production to delivery, distribution, prescribing, possession and use. The CSA’s impact is far-reaching, touching many different sectors of our society, including healthcare, pharmaceuticals, law enforcement, politics, and state and federal judiciaries.

According to the CSA, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This statutory language is at the root of the issue. But who decides what is a legitimate medical purpose?

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken a proactive approach in determining which medical practices have a legitimate medical purpose and which do not. This hands-on approach is in direct contravention with the CSA. 

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The DEA is effectively preempting state law as it relates to the regulation of controlled substances. In Gonzales v. Oregon, the U.S. Supreme Court ruled in 2006 that the authority to determine a legitimate medical purpose rests with state governments.

This means it is state lawmakers, not federal officials, who should regulate the practice of medicine. Medical boards are established by the authority of each state to protect the health, safety and welfare of patients through proper licensing and regulation of physicians and other practitioners.

If a doctor engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that doctor is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ, as well as state regulators.

The key phrases -- "legitimate medical purpose" and "in the usual course of a professional practice" -- are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years. The only way the phrase "legitimate medical purpose" would have any legal meaning would be if the concept of an "illegitimate medical purpose" were defined by the CSA -- and it is not.

Moreover, the words "legitimate" and "medical" are redundant. The practice of medicine is inherently legitimate, according to the CSA. The phrase "legitimate medical purpose" can be reduced to "medical purpose" without changing its meaning.

Any practice that is medical is legitimate and should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

Standard of Care

The DOJ is now using deviation from the “standard of care” to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids. A standard of care is generally considered the customary or usual practice of the average physician.

In an attempt to address the opioid problem, the DOJ has hired medical experts who claim that any deviation from standard of care amounts to practicing without a legitimate medical purpose. In some instances, the government's experts have even used the CDC opioid guideline’s dose recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose.

Using deviations from "standard of care" as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling in Gonzalez v Oregon, which found that the Attorney Generalis not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ. This is supported by a 1983 statement in a DEA newsletter that declares acts of prescribing or dispensing controlled substances lawful when they are done within the course of a provider’s professional practice. Even if a physician's behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

The information provided in the newsletter isn't an opinion. It's the law.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard. It is not the DOJ's role to determine the quality or boundaries of the practice of medicine.

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 Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Hydrocodone Rescheduling Fueled Online Drug Sales

By Pat Anson, Editor

Hydrocodone was once the most widely prescribed and one of the most abused drugs in the United States. Over 135 million prescriptions were filled in 2012 for hydrocodone combination products such as Vicodin, Lortab and Norco.

Then in 2014 the Drug Enforcement Administration rescheduled the opioid painkiller from a Schedule III controlled substance to the more restrictive category of Schedule II. The move was intended to reduce the prescribing of hydrocodone – and it quickly had the desired effect.  By 2017, only 81 million prescriptions for hydrocodone were filled.  

But while legal prescriptions for hydrocodone have gone down, the DEA’s 2014 rescheduling may have fueled a surge in illegal online sales of hydrocodone and other opioids, according to a new study in the British Medical Journal.    

“The scheduling change in hydrocodone combination products coincided with a statistically significant, sustained increase in illicit trading of opioids through online US cryptomarkets. These changes were not observed for other drug groups or in other countries,” wrote lead author Jack Cunliffe, PhD, a lecturer in data analysis and criminology at the University of Kent.

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Cunliffe and his colleagues studied these online cryptomarkets – also known as the “dark web” – by using web crawling software that scans the internet looking for websites dedicated to online sales of illicit drugs. From October 2013 to July 2016, they found that sales of prescription opioids on the dark web nearly doubled, from 6.7% to 13.7% of all online drug sales.  

“Our results are consistent with the possibility that the schedule change might have directly contributed to the changes we observed in the supply of illicit opioids,” said Cunliffe. “One explanation is that cryptomarket vendors perceived an increase in demand and responded by placing more listings for prescription opioids and thereby increasing supply.”

‘Iron Law of Prohibition’

The increase in supply and demand wasn’t just for hydrocodone. The researchers also noted a growing number of online listings for more potent opioids, such as oxycodone and fentanyl. They attribute that to the “iron law of prohibition” – banning or reducing the supply of one drug encourages users to seek more potent drugs from new sources.

“We found that users were first buying oxycodone followed by fentanyl. Drug users adapt to their changing environment and are able to source drugs from new distribution channels if needed, even if that means by illegal means. In a context of high demand, supply side interventions are therefore likely to push opioid users towards illicit supplies, which may increase the harms associated with their drug use and make monitoring more difficult,” Cunliffe wrote.

As PNN has reported, business is booming for illegal online pharmacies. As many as 35,000 are in operation worldwide and about 20 new ones are launched every day. About half are selling counterfeit painkillers and other medications. Overdoses involving fentanyl and other synthetic opioids – most of them purchased on the black market – have also increased and now outnumber those linked to prescription opioids.

"The study’s findings are troubling but not surprising. As you’ve well reported, there are often unexpected and negative externalities resulting from well-intended anti-addiction interventions," Libby Baney, Principal, Faegre Baker Daniels Consulting and senior advisor to Alliance for Safe Online Pharmacies said in an email to PNN. 

"What’s worse still, when buying medicine online - whether from dark or surface web sellers - it is virtually impossible for the consumer to know if the product is what it claims (in this case, an opioid like oxycodone) or is a dangerous counterfeit laced with a deadly dose of elephant tranquilizer or poison. As too many victims have shown, even one pill can kill."

A recent study at the University of Texas Medical Branch also found an association between hydrocodone's rescheduling and increased opioid abuse.  Researchers found that hydrocodone prescriptions for Medicare patients declined after rescheduling, but opioid-related hospitalizations increased significantly for elderly patients who did not have a prescription for opioids.

Critics Say DEA Plan Could Worsen Opioid Shortages

By Pat Anson, Editor

Pain sufferers and patient advocates are overwhelming opposed to plans by the U.S. Drug Enforcement Administration to further restrict the supply of opioid medication to punish drug makers that allow too many of their painkillers to be diverted and abused. Health organizations also caution that the proposal could worsen an acute shortage of pain medication in the nation’s hospitals.

Over 1,500 people left public comments in the Federal Register on the DEA’s plan to change the rules governing opioid production quotas. Under the proposal, the DEA could arbitrarily reduce the amount of opioids a company can make -- even if it has no direct role in the diversion or abuse.

"It’s a common sense idea: the more a drug is diverted, the more its production should be limited," said Attorney General Jeff Sessions. 

But critics say the plan will not prevent opioid abuse and will likely harm patients.

“The DEA has no business deciding how much valid medicine can be produced. The doctors prescribing the medicine should dictate the amount. The DEA is going to cause a crisis,” wrote Tina Liles.

“Reducing opiate medication has done nothing to help the rate of overdose deaths in this country because opioid prescriptions are not the issue in this country it is illicit fentanyl and heroin,” said Nicole Garage.

“Limiting access to the only medication that helps to control severe, intractable pain will not stop the crisis; those who abuse or sell drugs illegally have not stopped due to current quotas and will not stop with any new quota reductions,” said James Loranc.

“The logic (behind) this DEA proposal is completely untested, unproven, and unsupportable. The shortages being seen in hospitals and by pain patients will only get worse with further DEA cutbacks, leading to more mistakes, waste, and higher costs, not to mention additional pain,” said Valerie Padgett Hawk, Director of a Coalition of 50 State Pain Advocacy Groups.  

Hospitals Rationing Opioids

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The shortages mainly involve injectable opioids such as morphine, hydromorphone and fentanyl, which are used to treat acute pain in patients recovering from surgery or trauma. Hospitals have been forced to ration opioids or use other pain medications that are not as effective.

“With limited availability of some opioids, operations may have to be postponed or cancelled.  In some cases, this could prove life‐threatening to the patient,” wrote Janis Orlowski, MD, Chief Health Care Officer for the Association of American Medical Colleges. “We urge the DEA to remember that opioids are also an important part of treatment regimens for controlling acute and chronic pain in a variety of patients – including trauma, postoperative and patients with advanced stage cancer – and any limits on quotas should not negatively impact access for patients that have a legitimate and critical need for these medications.”  

“Please, I beg you, don't do this. My dear friend Sarah takes painkillers for her rheumatoid arthritis. Even with the medication it's terrible; without it, I have no doubt she'll kill herself. Her mental health is already fragile,” wrote Kelsey Hazzard. “This regulation will destroy her.”  

“For the love of God let the doctors and pharmacists handle prescribing and filling prescriptions and allow the patients and doctors to worry about how much opioid pain medication they need to take. This is none of the DEA’s concern!” wrote Brandon Tull, a disabled police officer who shared the tragic story of Jennifer Adams, a Montana pain patient who recently committed suicide.

“That suicide will probably be the first in a long line if you continue this attack upon innocent chronic pain sufferers!”

The public comment period on the DEA proposal ended May 4th. The public was given only 15 days to comment in the Federal Register on the rule change. Public comment periods are usually between 30 and 60 days long, with some taking up to 180 days. Agencies are allowed to use shorter comment periods "when that can be justified."

"This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history," the DEA said.

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25% in 2017, followed by a 20% cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Under the proposed rules, the DEA would be required to consult with states, Food and Drug Administration, Centers for Disease Control and Prevention, and the Department of Health and Human Services before setting opioid quotas. The rule change was triggered by a lawsuit filed against the DEA by West Virginia, alleging that the current quota system “unlawfully conflates market demand for dangerous narcotics” with the legitimate needs of pain patients.    

Although overdose deaths from heroin, illicit fentanyl and other street drugs now surpass those from pain medication, the DEA claims prescription opioids are gateway drugs to long-term substance abuse.

“(Opioid) users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue,” the DEA said.

According to the National Institutes of Health (NIH), only about 5 percent of patients taking opioids as directed for a year end up with an addiction problem. And the DEA itself estimates that less than 1% of legally prescribed opioids are diverted.

DEA Takes Steps to Reduce Hospital Opioid Shortages

By Pat Anson, Editor

In response to a growing number of complaints about shortages of opioid pain medication in U.S. hospitals, the Drug Enforcement Administration is allowing some drug makers to increase their production of injectable opioids.

The shortages were first reported last summer but have intensified in recent months – leaving some hospitals scrambling to find morphine, fentanyl and other injectable opioids to treat patients suffering from acute pain after surgery or trauma. The shortages are largely due to manufacturing problems at Pfizer, which controls 60 percent of the market for injectable opioids.

“DEA is working closely with the U.S. Food and Drug Administration, drug manufacturers, wholesale distributors and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl,” the agency said in a statement.

The DEA said it gave permission to three other drugs makers to produce the injectable drugs after Pfizer “voluntarily surrendered” part of its quota allotment.

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“It is important to note that an increase in DEA procurement quotas to various manufacturers cannot alone prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products,” the agency said.

But critics say the DEA itself is partly responsible for the shortages. The agency may not control how companies manufacture drugs – but it has a big say on the amount. Under federal law, the DEA sets annual production quotas for each drug maker to produce opioids and other controlled substances.

Because of growing concerns about the overdose crisis, the DEA ordered a 25 percent reduction in opioid manufacturing in 2017 and an additional 20 percent cut in 2018. This year’s cuts were ordered despite warnings from three drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

A group of 16 U.S. Senators – led by Illinois Democrat Dick Durbin – urged the DEA to make the production cuts. 

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the senators wrote in a September 2017 letter to then acting DEA administrator Chuck Rosenberg.

According to Kaiser Health News, shortages of injectable opioids have led to an increasing number of medical errors and left trauma patients suffering in pain. Some hospitals are rationing opioids like Dilaudid, and using nerve blocks, acetaminophen and muscle relaxants instead.

The DEA said it would make further adjustments to opioid quotas if they are needed and would “also consider other measures that may be necessary.”

DEA Tactics Questioned in Tennant Raid

By Roger Chriss, Columnist

Agents with the Drug Enforcement Administration recently raided the offices and home of Dr. Forest Tennant, a prominent pain physician in California. According to an affidavit the DEA filed in support of a search warrant, Dr. Tennant is “profiting from the illicit diversion of controlled substances” and is part of a drug trafficking organization that has “submitted millions of dollars in fraudulent Medicare prescription drug claims.”

Dr. Tennant, who was recently honored with a lifetime achievement award,  has not be charged with a crime and denies doing anything wrong.  He says the DEA is out to smear his reputation and those of other doctors who prescribe opioid pain medication.

The DEA’s mandate includes protecting the public from inappropriate distribution of drugs, including opioids, and securing the supply of all controlled substances. But the DEA’s methods have long been scrutinized and found wanting.

A study from 2008 identified 725 doctors who were charged with offenses involving opioid medication. Of those, about 40 percent were general or family practice physicians, and only 3.5% were board-certified pain specialists.

A 2016 study attempted to quantify the nature of these investigations. Researchers analyzed 100 cases of allegedly improper opioid prescribing and found that most of the physicians were male (88%); over 40 years of age (90%); non-board certified (63%); and nearly all were in small private practices (97%). A little over half of the doctors (54%) were said to have “self-centered personality traits.”

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A thorough review of the legal issues involved in improper opioid prescribing came to several important conclusions. First, that the “information available about physician misprescribing is in small supply.” This alone is surprising, since the DEA, as well as the FDA, state medical boards and pharmacies would seem well-equipped to have very granular data about opioid prescribing practices.

Next is the “4D Model” of investigations, which typically group “misprescribers” into four categories: dated, duped, disabled or dishonest. The model emerged in the late 1970s from work by addiction medicine experts, but has been shown to be dysfunctional at best, and arguably even damaging to both pain medicine specialists and chronic pain patients.

In particular, the 4D Model cannot readily be applied to misprescribing because “dishonest” is too vague and narrow. As a result, “for liability to attach to physicians, they must prescribe controlled substances knowingly; without a legitimate medical purpose; and outside the course of professional practice.” As the raid on Dr. Tennant suggests, these criteria are not always satisfied, as his very sick patients will attest.

But the DEA is empowered to investigate as it sees fit. The DEA says the “types of cases in which physicians have been found to have dispensed controlled substances improperly under federal law generally involve facts where the physician’s conduct is not merely of questionable legality, but instead is a glaring example of illegal activity.”

Prosecution of Doctors Increasing

Since 2008 the DEA has been adding agents and resources to its ranks. From the review article, “the squads increased investigations, inspections, and administrative actions significantly” and “the number of criminal malpractice prosecutions in this area has also risen.”

That is having a substantial impact on the world of pain management. Although investigations are certainly warranted in cases like pill mills, rogue doctors, and illegal online pharmacies, most DEA investigations do not result in criminal charges. But even a warning letter from the DEA to one physician at a healthcare facility can have a chilling effect on prescribing practices in the entire facility. Thus, the DEA’s actions can ripple out to chronic pain patients far removed from the target of an investigation.

It is also important to note that DEA investigations and resulting charges are often dismissed. In a blog post  in support of Dr. Tennant, pain management expert Dr. Lynn Webster recounts his own experience with a DEA investigation that was dropped four years after it began.

“The DEA wanted information, but even more, they wanted to exhibit a show of force to intimidate my patients, employees, and me,” said Webster.

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In Florida, Dr. Debra Roggow was caught up in a pill mill investigation, mostly based on the amount of opioids she prescribed. Roggow was ultimately acquitted of all charges, but not until her reputation and practice were ruined.

"This has been a horrifying, humbling experience," she said. "I was worried, of course. I knew of my innocence, but innocent people do go to jail."

There is a vast gulf between a legitimate pain specialist like Dr. Tennant and a pill mill.

As Sam Quinones describes in his book Dreamland, “If you see lines of people standing around outside, smoking, people getting pizza delivered, fistfights, and traffic jams—if you see people in pajamas who don’t care what they look like in public, that’s a pill mill.”

Misprescribing opioids is not a well-studied or well-understood problem. This is peculiar, given that it is now 20 years since the start of the opioid crisis. The current 4D Model is flawed, and given the influx of heroin and illicit fentanyl into the country, the DEA does not seem to be fulfilling its mission statement of “reducing the availability of illicit controlled substances on the domestic and international markets.”

The raid on Dr. Tennant’s practice may be part of a legitimate operation, such as the investigation of Insys Therapeutics and its fentanyl product Subsys. But if so, that arguably could have been accomplished without the drama of DEA agents swarming into a small medical practice or breaking into the home of a respected 76-year physician while he and his wife were out of town.

A spirit of cooperation between physicians and law enforcement would go a long way to help pain management specialists and their patients in the opioid crisis.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Senators Pressed DEA to Cut Rx Opioid Supply

By Pat Anson, Editor

A group of 16 U.S. senators played an influential role in getting the Drug Enforcement Administration to make further cuts in the supply of opioid pain medication, the latest example of how politicians have inserted themselves into the healthcare choices of Americans.

As PNN reported, the DEA published an order last week in the Federal Register that cut the 2018 production quotas for Schedule II opioid painkillers by 20 percent. It’s the second year in a row the DEA has ordered steep reductions in the supply of opioids. The move affects several commonly prescribed medications that millions of pain patients rely on for relief, such as oxycodone, hydrocodone, morphine and codeine.

The DEA acted even after drug makers and patients warned the agency that the cuts were so severe they could lead to shortages of pain medication. Under federal law, the DEA sets production quotas for manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more.

The 16 senators – 15 Democrats and one independent – have been urging the DEA for months to go even further to reduce the risk of opioid painkillers being abused.

“As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” Democratic Sen. Dick Durbin of Illinois wrote in a letter to DEA Acting Administrator Chuck Rosenberg on July 11.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

SEN. DICK DURBIN

SEN. DICK DURBIN

Durbin’s letter was co-signed by 15 of his Senate colleagues: Sherrod Brown (D-OH), Amy Klobuchar (D-MN), Edward Markey (D-MA), Joe Manchin (D-WV), Dianne Feinstein (D-CA), Claire McCaskill (D-MO), Patrick Leahy (D-VT), Tammy Baldwin (D-WI), Jeanne Shaheen (D-NH), Kirsten Gillibrand (D-NY), Catherine Cortez Masto (D-NV), Maggie Hassan (D-NH), Richard Blumenthal (D-CT), Al Franken (D-MN) and Angus King (I-ME).

Durbin followed up with a personal meeting with Rosenberg at DEA headquarters on August 3. The meeting was also attended by Senators Brown, Shaheen, Manchin, Markey and Hassan.

“I commend Administrator Rosenberg for acknowledging that the DEA can do more to keep dangerous painkillers off our streets,” Durbin said in a statement after the meeting.  “In today’s meeting, I asked him to continue this effort and further lower the opioid quotas for 2018.  Fewer pills on the market means less addiction and, hopefully, fewer deaths.”   

The August 3 meeting is important, because the very next day the DEA announced it would publish a notice in the Federal Register that it was planning a 20% reduction in Schedule II opioids for 2018.

rosenberg (left) meeting with durbin and other senators

rosenberg (left) meeting with durbin and other senators

The notice opened up a 30-day public comment period on the DEA’s proposal. Over a hundred people wrote in, most of them pain sufferers who warned the DEA it was going too far.

“The quotas for 2017 caused some shortages at pharmacies. I do not understand the reasoning behind more aggressive production quotas for 2018. People I know who are long term chronic pain patients have gone to the pharmacy for their prescription and are told that it will be a week or 10 days to fill the prescription,” wrote Marjorie Zimdars-Orthman. “It is cruel to implement quotas that will cause pharmacy shortages.”

“This is just beyond insane. Far too many people are already suffering and committing suicide due to not being able to get proper pain management,” said Eric Busch. “Even those that find a doctor willing to actually treat the pain humanely and write a prescription, might not be able to fill said prescription if there are artificial quotas and shortages.”

“How can the government ensure that these quotas will not adversely affect pain patients?” asked Brian Teer, whose wife has suffered from chronic pain for nearly 20 years. “I implore you to consider the medical needs of unfortunate patients like my wife, who face the burden of untreated intractable pain. Please do not reduce the production of the very medications that she needs to continue living. Please do not take her life.”

The DEA said three unidentified drug makers also made comments, warning that the 2018 quotas for codeine, fentanyl, hydrocodone, methadone, morphine, oxycodone and oxymorphone “were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States.”   

The only comment left in support of the 2018 production quotas included a second letter from Durbin and his colleagues, warning that opioid supplies “remain far too high.”

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the letter said.

In the end, the DEA sided with the 16 senators, ruling that the 2018 opioid quotas were “sufficient” to meet the needs of patients. The agency dismissed the comments from pain sufferers as medical complaints that were “outside of the scope” of its final order.

“These one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas,” wrote Robert Patterson, who became acting head of the DEA after Rosenberg resigned unexpectedly in September.

Opioid Quotas Should ‘Continue to Come Down’

Sen. Durbin and his colleagues are apparently not done yet, and may seek to rein in the supply of opioids even further in 2019.

Durbin recently joined with Sen. Markey in introducing the Opioid QuOTA Act, a bill that seeks more transparency from the DEA in disclosing how it sets opioid production quotas. The legislation would require the agency to list on its website the production quota for each opioid manufacturer, information that the DEA now considers confidential.

“The public deserves the right to know which drug companies are manufacturing these opioids, how many they are producing each year, and their justification for asking the DEA to approve their ever-increasing quota requests,” Durbin said in a statement.

“Our work will not be done until these quotas continue to come down, doctors become more judicious in their prescribing, drug companies stop misleading the public about their products, and we do more to help those who are currently addicted get treatment.”

Along with Durbin and Markey, the legislation is co-sponsored by Senators Manchin, Brown, Shaheen and Hassan – the same group of senators that met with the DEA administrator in August and pressed him to make further cuts in the opioid supply.

DEA Cutting Rx Opioid Supply in 2018

By Pat Anson, Editor

The U.S. Drug Enforcement Administration is going ahead with plans to reduce the supply of many opioid painkillers by 20 percent next year. That’s in addition to steep cuts in opioid production quotas the agency imposed in 2017.

In a notice quietly published this week in the Federal Register, the DEA said it would reduce the supply of many commonly prescribed Schedule II opioid painkillers, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, and fentanyl. The agency said demand for the medications had dropped.

In proceeding with the cuts, which were first proposed in August, the DEA dismissed warnings from three drug makers that the reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

The DEA received over 100 public comments on its proposal, most of them expressing concern that any further reduction in opioids would adversely impact the availability of prescription painkillers.

“I am 75 years old, have metastatic prostate cancer in my bones and have to take high doses of fentanyl patches and morphine tablets for the chronic, intractable pain. Please do not further reduce the supply of my critical medicine,” wrote Bill Daniel.

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“Please stop this misguided attempt to save people from themselves. If demand is down, it's because you bullied physicians into prescribing less, not from a genuine market conditions,” wrote one anonymous poster.

“You want to cut my access to the medication I'm legally prescribed by my pain management doctors! Would you consider the same for people deemed disabled due to other illnesses? You are going to cause millions of us to either commit suicide due to unbearable pain or turn to street drugs,” said Christa Rood.

The DEA said comments such as these dealt with medical issues that were “outside of the scope” of its order and did not offer any new data for the agency to consider.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Those cuts were not sufficient to stop the opioid epidemic, according to two letters sent to the DEA by a group of U.S. senators. The first letter, sent in July, urged that "further reductions... are necessary to rein in this epidemic.”

A second letter, sent in September, said there was "no adequate justification for the volume of opioids approved for the market." The senators asked to DEA to make the 2018 cuts in the opioid supply at least as deep as they were in 2017. 

Opioid prescriptions have actually been in decline for several years.  According to the Centers for Disease Control and Prevention, opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

In recent years, heroin and illicit fentanyl have emerged as the driving forces behind the overdose crisis, which killed an estimated 64,000 Americans in 2016. Despite that, federal efforts to prevent overdose deaths remain largely focused on reducing the use of prescription painkillers.

The CDC, for example, is spending $4.2 million on an Rx Awareness campaign in four states; running ads on billboards, radio, newspapers and online that warn about the risks of prescription painkillers. Although a recent CDC study found fentanyl was involved in over half the overdoses in ten states, the agency says it has no plans to include fentanyl or heroin in its awareness campaign.

“Our aim with this campaign is to prevent prescription opioid overdose deaths, since prescription opioids continue to be involved in more overdose deaths than any other drug. Based on studies of people entering treatment, the majority of people with opioid use disorder (including heroin use disorder) still start with prescription opioids,” CDC spokesperson Courtney Lenard said in an email.

DEA Proposes Further Cuts in Opioid Supply

By Pat Anson, Editor

The U.S. Drug Enforcement Administration has proposed an additional 20 percent reduction in the manufacture of many opioid painkillers, including oxycodone, hydrocodone, codeine and morphine. The proposed cuts in the opioid supply, which would be effective in 2018, are in addition to those imposed by the DEA in 2017.   

“Demand for these opioid medicines has dropped,” the DEA said in a news release, citing sales data released by the QuintilesIMS Institute, which tracks prescription drug use. About 7 million fewer prescriptions were filled for hydrocodone in 2016, the fifth consecutive year that hydrocodone prescriptions have dropped.

“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said DEA Acting Administrator Chuck Rosenberg. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

Many pain patients tell PNN that demand for opioid medicine has not dropped, but that doctors are increasingly reluctant to write opioid prescriptions because of increased oversight by the DEA, insurance companies, and federal and state regulators.  

“It is discrimination, plain and simple. I have a well-documented chronic pain condition. Social Security has deemed me 100 percent disabled,” wrote Lora Lemons. “No other chronic condition that requires medication to combat the disease is flagged the way pain producing diseases are.”

“I am prepared to commit suicide if my pain meds are drastically cut,” wrote a woman who has adhesive arachnoiditis, a chronic and disabling spinal condition. “We don't want to die, but the legislators in the federal and state governments are going to force it for those in intractable pain.”

“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 doctors are afraid to treat us humanely and adequately,” said Candi Simonis.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Despite those deep cuts, the DEA remains under political pressure to combat the overdose epidemic by reducing the opioid supply even further. Last month, a group of 16 U.S. senators wrote to Rosenberg saying additional cuts “are necessary to rein in this epidemic.”

The DEA published notice of its intent in the Federal Register and is accepting public comments on the proposal until September 6.

Click here to post your comment on the 2018 production quotas.

FDA Nominee Called for DEA to Stop Policing Pain Care

By Pat Anson, Editor

President Trump has nominated a doctor who has proposed radical changes in the regulation of opioid pain medication as the next head of the Food and Drug Administration.

Scott Gottlieb, MD, is a former deputy FDA commissioner and has worked as a consultant to several drug companies. He is currently a fellow at the conservative American Enterprise Institute.

If confirmed by the U.S. Senate as FDA commissioner, The Washington Post reports the 44-year old Gottlieb is “likely to try shaking it up in significant ways,” by speeding up the agency’s approval of new drugs – what President Trump has called a “slow and burdensome” process.

Also of note to pain patients, pharmacists and doctors is that Gottlieb may seek to reduce the role of the U.S. Drug Enforcement Administration in regulating and policing opioid pain medication.

In a column published in The Wall Street Journal in 2012 – which carried the headline -- "The DEA’s War on Pharmacies – and Pain Patients” – Gottlieb wrote that patients would suffer less if medical regulators, not law enforcement agencies, monitored the dispensing and consumption of opioid medication.

scott gottlieb, md

scott gottlieb, md

“What can be done? We should free the DEA from the dual mandate to be both regulator and cop,” Gottlieb said. “This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need. But the DEA tactics aren’t stemming the illegal activity.”

At the time the DEA had just slapped severe penalties on drug wholesaler Cardinal Health for shipping large amounts of opioids to four Florida pharmacies that were essentially operating as pill mills. The backlash from that case led pharmacies across the country to start turning away pain patients with legitimate opioid prescriptions.

“Cardinal has suspended sales to hundreds of pharmacies that it deems ‘suspicious,’ even those in good standing that retain their DEA license to sell narcotics,” wrote Gottlieb. “Pharmacies, in turn, are closely scrutinizing which prescriptions they will fill, making things like baggy pants and a tattoo a liability if you need medicine.”

Calling the DEA the “wrong enforcer” for the job, Gottlieb proposed a radical move: Have the DEA concentrate on street drugs and drug cartels, while the Department of Health and Human Services regulates doctors, pharmacies and others involved in dispensing pain medication.

“Public-health agencies inside the Department of Health and Human Services (HHS) would have more expertise in making the distinctions between illicit diversion and the legitimate practice of medicine. Regulating these activities requires close knowledge of how medical-practice decisions are made, as well as the ability to collaborate with provider groups to enlist them in achieving regulatory goals. Some of the DEA’s resources and mission could be statutorily given to HHS,” Gottlieb wrote.

“A good line of demarcation would be at the point of care. Doctors prescribing narcotics, drug distributors and pharmacies could come under the supervision of HHS. The department would also take responsibility for apportioning active ingredients to manufacturers of narcotics, educating doctors on proper prescribing, and investigating pharmacies and providers who appear to have gone rogue.”

Gottlieb wrote that column five years ago and it is not known if he still holds those beliefs. The current political atmosphere in Washington about opioids may also cool his enthusiasm for stripping the DEA of one of its primary jobs. But it is interesting that he proposed it.

Gottlieb’s ties to the pharmaceutical industry may come under scrutiny during confirmation hearings. Activists are already lining up in opposition to his expected nomination, calling some of Gottlieb's ideas about deregulation “dangerous.”

“Scott Gottlieb is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry and the U.S. Senate must reject him,” said Dr. Michael Carome, Director of Public Citizen’s Health Research Group

“Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. The Senate must reject the nomination and demand a nominee who is better suited to protect public health.”

DEA Delays Kratom Ban for ‘Modified Comment Process'

By Pat Anson, Editor

The U. S. Drug Enforcement Administration, which refused to allow any kind of public comment on its decision to make the sale and possession of kratom illegal, has reversed course and will now allow a “modified comment process.”

The DEA could have classified two active ingredients in kratom as Schedule I controlled substances on Friday, September 30, but apparently caved in to political pressure to leave the legal status of the herbal supplement unchanged, at least for the time being.

The decision was made public by Wisconsin Rep. Mark Pocan (D), who circulated a letter on Capitol Hill this week urging the DEA to postpone its decision. A bipartisan group of 51 congressmen signed the letter.

“Congressman Mark Pocan had a productive conversation with the acting (DEA) administrator today and learned that the DEA will be not announcing a final decision on kratom today,” Pocan’s office said in a statement released on Twitter.

“It appears the DEA will instead open up a modified comment process before a final decision will be made. While we do not know the exacting timing or details of the new comment period for kratom, Acting Administrator Rosenberg assured Congressman Pocan that we will find out more in the near future.”

No further details were released by Pocan or the DEA, although kratom activists were encouraged by the development.

“The DEA will be releasing a statement in the next few days about opening a public comment period and exactly what that will look like. Obviously we are going to need to flood them with comments!” said Susan Ash, founder of the American Kratom Association in a Facebook post.

“Aside from every single person writing in with their testimonies, we will need to get as many medical professionals (preferably MDs) and scientists to submit comment and testimony as we possibly can to challenge the claims that Kratom is an opiate and that it has no medicinal use.”

As Pain News Network has reported, in recent days it appeared increasingly unlikely the DEA would follow through on its threat to schedule kratom as a controlled substance – alongside heroin, LSD and marijuana – because of growing pressure from the public and Congress.

In an emergency scheduling order published in the Federal Register on August 30, the DEA said kratom, which comes from the leaves of a tree that grows in Southeast Asia, poses “an imminent hazard to public safety” and has been linked to several deaths.

Kratom supporters, however, say the herb is relatively harmless and is very effective at relieving symptoms of chronic pain, anxiety, depression and other medical conditions. Questions were also raised about the process the DEA used in making decision, which gave no public notice and solicited no public comment.

In addition to Pocan’s letter, a dozen U.S. senators have signed letters urging the DEA to delay scheduling kratom and to solicit more public input.

“Congress granted emergency scheduling authority to the DEA based on the need for law enforcement interdiction of new and previously unknown illegal synthetic street drugs that result in injuries and death. The use of this emergency authority for a natural substance is unprecedented,” Utah Sen. Orrin Hatch (R) said a a draft letter to acting DEA administrator Charles Rosenberg.

“Given the long reported history of Kratom use, coupled with the public’s sentiment that it is a safe alternative to prescription opioids, we believe using the regular review process would provide for a much-needed discussion among all stakeholders.”

Sen. Hatch’s involvement in the kratom controversy is important because he is a longtime supporter of the dietary supplement industry. As the powerful chair of the Senate Finance committee, Hatch also plays in a major role in determining the DEA’s budget.

Exactly what the DEA means by a “modified comment process” remains to be seen. The decision is reminiscent of a delay announced by the Centers for Disease Control and Prevention last December, when its draft opioid prescribing guidelines were met with sharp criticism by healthcare advocacy groups, patients and doctors.

The CDC opened a 30-day public comment period and received over 4,000 public comments – most of them opposing the guidelines. But in the end, very few changes were made to the opioid guidelines, which are now being widely adopted by prescribers. Many chronic pain patients say they are now unable to obtain the opioids they were safely prescribed for years.