FDA and DEA Leaders Call for More ADHD Meds, But Ignore Rx Opioid Shortages

By Pat Anson, PNN Editor

Leaders of the Food and Drug Administration and the Drug Enforcement Administration say they’re working to end one of the worst drug shortages in decades.

“The lack of availability of certain medications in recent months has been understandably frustrating for patients and their families,” FDA commissioner Robert Califf, MD, and DEA Administrator Anne Milgram said in an unusual joint letter. “We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, to do all they can to ensure access for patients when a medication is appropriately prescribed.”

Those should be welcome words for pain patients across the U.S. who have trouble getting their prescriptions filled for opioid medication. Unfortunately, the letter has nothing to do with opioids. It’s only about shortages of Adderall and other prescription stimulants, which are used primarily to treat attention-deficit/hyperactivity disorder (ADHD).

The letter is the latest example of how the FDA and DEA have turned a blind eye to opioid shortages, which both agencies have played prominent roles in creating. Two widely used painkillers, oxycodone and hydrocodone, have been difficult to get for months, leaving thousands of patients in uncontrolled pain or going into withdrawal. Even big chain pharmacies like CVS are out of opioids or have a limited supply.   

“I had to once again follow up with CVS, just to be told they received absolutely nothing! Pain management provider in response sent another prescription to the outpatient pharmacy,” says Christine Kucera, a pain patient who recently wrote a column for PNN about her problems getting prescriptions filled for oxycodone.

“I'm currently sitting in the waiting area at the outpatient pharmacy, stressing, waiting for another bomb to drop.”

The American Society of Health-System Pharmacists (ASHP) first warned about a shortage of immediate release oxycodone in March. Over the next few months, hydrocodone/acetaminophen tablets (Vicodin) and oxycodone/acetaminophen tablets (Percocet) were added to the ASHP’s shortage list. Those shortages could soon grow even worse, because one of the largest generic drug makers in the world, Teva Pharmaceutical, is discontinuing production of immediate release oxycodone. 

Despite these warning signs, the FDA and DEA have yet to acknowledge shortages of either oxycodone or hydrocodone, and appear to be doing nothing about them. But they are moving to boost production of stimulants used to treat ADHD. The agencies say drug makers have sold only 70% of the stimulants they were authorized to produce.   

“We want to make sure those who need stimulant medications have access,” Califf and Milgram said in their letter. “We have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount.” 

“What this latest notice shows is that the FDA and DEA could get involved with the opioid shortage if they wanted to,” says Rick Martin, a retired pharmacist disabled by back pain. Martin recently had to switch to a weaker opioid for pain relief because he can’t find a pharmacy with hydrocodone in stock.

“Teva said they were going to stop making oxycodone. The DEA/FDA could be proactive and ask Teva to relinquish their remaining 2023 quota allotment, then redistribute to other manufacturers,” Martin told PNN. 

Lower Production Quotas

The DEA sets annual production quotas for opioids, stimulants and other controlled substances, working closely with the FDA in assessing demand. Last year, the FDA advised the DEA that demand for hydrocodone, oxycodone and other Schedule II opioids would fall by 5.3% in 2023, which resulted in another year of cuts by the DEA in opioid production. Since 2013, the supply of oxycodone has fallen by 65 percent and hydrocodone by 73 percent. 

The FDA also advised the DEA that domestic medical use of stimulants would fall by 0.1% in 2023, even while warning that shortages were developing. The DEA’s response last December was that amphetamine and other stimulants were overprescribed to patients who didn’t really need them, and that its proposed production quotas (APQ) for the drugs in 2023 would be adequate.

“The majority of the manufacturers contacted by DEA and/or FDA have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs,” the DEA said in the Federal Register. “Based on this trend, DEA has not implemented an increase to the APQ for amphetamine at this time.”

That kind of background detail is missing from Califf’s and Milgram’s letter, which disingenuously claims that there is little that the DEA and FDA can do to ensure that there are adequate supplies of medication. 

“This is not a problem that the FDA and DEA can solve on our own,” Califf and Milgram wrote. “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.” 

Only briefly do Califf and Milgram acknowledge that their own production quotas are part of the problem, saying they were “committed to reviewing and improving our quota process.” 

“These (stimulant) shortages were caused by the DEA, which limited the manufacture of these medications,” says Andrea Anderson, a pain sufferer and patient advocate. “This exact problem has affected patients who require opioid analgesics to manage their severe pain. It has been affecting them for over six years, yet we see no mention of the extraordinary difficulties these patients are experiencing trying to find pain medication.  

“The DEA has no reason to be involved in deciding how many prescriptions should be written for any medical condition. This is the purview of trained medical clinicians and quantities should not be dictated by law enforcement agencies.” 

Drug manufacturers are required to report shortages and supply interruptions to the FDA. Doctors, hospitals, pharmacies and consumers can also report supply problems by sending an email to drugshortages@fda.hhs.gov.

That’s where Christine Kucera recently sent an email addressed to the FDA commissioner.

“Three different medications used in my treatment are continuously unavailable, sometimes for weeks and months. CVS IS OUT, the system is not working, and all you do is NOTHING!” Kucera wrote to Califf. 

“When will you address the unethical treatment and harms being inflicted upon millions of US citizens directly caused by government practicing medicine, limiting and denying access to essential medicines based on biased and manipulated facts, reduced quotas, faulty CDC prescription guidelines that should never have been created; and the DEA who are making up their own rules, practicing medicine, and deciding what they think appropriate medical care is?”  

FDA Head Says Drug Shortages ‘Out of Our Control’

By Pat Anson, PNN Editor

With drug shortages in the U.S. near record levels, the head of the Food and Drug Administration says there is little his agency can do to ease shortages, particularly those involving generic drugs.

“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in an interview with Medscape.  

There are currently 207 medications in short supply, according to the FDA’s drug shortage list, but the American Society of Health-System Pharmacists (ASHP) has a much higher estimate of over 300 active drug shortages, the most since 2014.

Shortages of generic medications used to treat cancer and attention deficit disorder (ADHD) have gotten the most attention, but there are also emerging shortages of generic oxycodone and other opioid pain medications. About 90% of prescribed drugs in the U.S. are low-cost generics.

“And this has caused a big problem, where a number of generic drugs are in shortage at any given time, because there's not enough profit for a company to say they want to go into the business of making that drug,” said Califf.

Teva Pharmaceutical, one of the world’s largest manufacturers of generic drugs, announced last month that it would change its business model to focus on more profitable branded drugs. Teva has already informed the FDA that it was discontinuing production of 30, 15, and 5 mg tablets of generic oxycodone.  

Another generic drug maker, Perrigo Pharmaceuticals, recently notified the FDA that it was stopping production of a cough syrup made with hydrocodone.

Pain patients have had trouble for years getting prescriptions filled for opioids, but the problem appears to have gotten more acute in recent months – and not just for generic opioids. Joy CobbWilliams told PNN she has trouble getting prescriptions filled for OcyContin, a branded formulation of oxycodone that she’s been taking for nearly a decade for chronic back pain.

“Month after month I run out of my medication while I wait for the pharmacy to get more. Some months I wait three or four days and other months I wait almost two weeks. The pain I suffer is unbearable,” she said. “Something needs to be done. We have got to do better for the patients suffering and not abusing the medication. This is the United States and there should be no reason someone suffering should have to wait days to weeks to get their 10mg OxyContin.” 

Kim Luarks told us she’s had problems with her pharmacy running out of fentanyl patches and Xtampza ER (oxycodone). She’s been on opioids for 20 years due to chronic back pain. 

“Here I sit, still waiting and have been without any long-acting opioid for (7 days) and not feeling too hot,” she said. “This could be detrimental to my life, let alone my heart and lungs that are already damaged due to the doctors just throwing pain meds at me in the early 2000’s. I've been through all the changes and federal regulations causing this nonsense.” 

The Drug Enforcement Administration, in consultation with the FDA, determines the annual production quotas for opioids and other controlled substances. Despite Califf’s contention that drug shortages are “out of our control,” it was the FDA that advised the DEA that demand for Schedule II opioids such as oxycodone would fall by 5.3% in 2023. 

DEA adopted the FDA’s recommendations and reduced the supply of opioids for the seventh consecutive year, saying it would be “sufficient to meet all legitimate needs.” Since their peak in 2013, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

In his interview with Medscape, Califf suggested that some medications are now in short supply not because of production quotas, but because they are prescribed to people who don’t really need them. He said stronger medical guidelines may be needed to discourage doctors from overprescribing.   

“If only the people that needed these drugs got them, there probably wouldn't be a shortage. There's a large amount of use which is on the margins. And this is why I say we need better clinical standards,” Califf said.

“But having said all that, we're working with the DEA frequently as they try to work out what the quotas are. And we're working with the companies to optimize production. So that shortage should go away. It's better now than it was a few months ago, and it's going to continue to get better.”

FDA Conducting Review of Opioid Regulations

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has launched an extensive review of its opioid regulations, with the goal of reducing overdoses and making revisions “to support appropriate use of opioid analgesics.”

In a blog post, FDA commissioner Robert Califf, MD, acknowledged the overdose crisis has “evolved beyond prescription opioids” and is now largely driven by illicit fentanyl and other street drugs. But he was vague about whether FDA would loosen restrictions on opioid pain medication or tighten them further.

“While the FDA’s previous strategies have largely focused on opioid use and overdoses, the evolving nature of the overdose crisis calls for both a new approach and honest reflection about what the FDA can do differently moving forward,” Califf said. “For example, during my confirmation process, I committed to undertaking a review of our opioid decisions, including labeling. We have initiated this review with the intended goal of understanding what revisions are needed to support appropriate use of opioid analgesics. Our ‘lessons learned’ will actively inform our future approach.”

One of the lessons learned by the CDC over the past few years is that rigid opioid prescribing guidelines have been harmful to patients and need to be “individualized and flexible.” The agency is currently in the process of revising its 2016 opioid guideline, with the goal of releasing an updated guideline late this year.

It’s not clear if the FDA is moving in a similar direction. One of the priorities for the agency’s new Overdose Prevention Framework is to “improve pain management and patient outcomes” – not by making opioids more accessible, but by reducing “unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.” 

Califf said the agency was studying the need for mandatory prescriber education about opioids, including a national continuing education program about the use of opioids to manage pain. Most medical schools in the U.S. and Canada do not require a course in pain education and few even offer pain management as an elective.

The FDA may also tighten the rules for getting new opioids approved, including a requirement that drug makers demonstrate that their products offer material safety advantages over existing opioid analgesics. At the same time, the agency is planning to release new guidance to speed up the development of non-opioid and non-addictive treatments for chronic pain.

This is the 70-year old Califf’s second stint as FDA commissioner, having previously served in that role during the Obama administration. He was confirmed for a second time by the U.S. Senate last December by a narrow 50 to 46 vote. At the time, he promised an extensive review of the FDA’s opioid regulations to counteract complaints that the agency did little to prevent opioid misuse and was too accommodating to drug makers.

Federal efforts to reduce drug overdoses by limiting opioid prescriptions have largely failed. While opioid prescribing has fallen by 48% over the past five years, overdoses soared to a record 107,000 drug deaths in 2021, driven primarily by illicit fentanyl.

A recent study found no “direct correlation” between opioid prescribing and overdoses. Another analysis of overdose deaths in 2020 found that prescription opioids ranked well behind illicit fentanyl, alcohol, cocaine, methamphetamine and heroin as the leading cause of drug deaths.   

FDA Head Wants New Regulations for Kratom and CBD

By Pat Anson, PNN Editor

The head of the Food and Drug Administration says his agency will need new authority from Congress to regulate both kratom and cannabidiol (CBD), two natural substances used by millions of Americans to self-treat their pain and other medical conditions.

FDA Commissioner Dr. Robert Califf testified on Thursday before a House Appropriations subcommittee, where he was asked why the agency was slow in developing new regulations for CBD and why it remained opposed to the use of kratom. Califf said new regulatory pathways were needed for both substances because they fall between the cracks of existing law that gives the FDA broad authority to regulate food and drugs.

“I don’t think the current authority we have, on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward. We’re going to have to come up with something new. I’m very committed to doing that,” said Califf.

Califf was recently confirmed by the U.S. Senate as FDA commissioner, a job he previously held under President Obama. He noted that little progress had been made at the FDA in regulating CBD and other cannabis products since he left the agency.

“You know, when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,” said Califf.

Some of the difficulty in regulating CBD comes from passage of the 2018 farm bill, which legalized hemp under federal law. At the time, it was believed that hemp had little or no psychoactive properties and would be relatively harmless. However, as PNN has reported,  some cannabis companies have found ways to concentrate delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and are using it in edibles to give consumers a mild intoxicating effect.

The FDA considers delta-8 THC an unapproved drug, but because it comes from hemp – a legal substance – its regulatory status is unclear.

“The amazing plethora of derivatives of the cannabis plant is really quite profound and astounding, and already in widespread use in a variety of means. Most of the FDA effort so far has been spent on research to figure out what the risks, if any, are of various uses of this material in its different forms,” said Califf. “The research so far has shown that there are some risks with CBD. And so, we’re going to need a different pathway than just the standard food pathway.”

FDA Kratom Info ‘Extremely Antiquated’

Califf took a similar stance on kratom, an herbal supplement that comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction — even though the FDA has not approved kratom for any medical condition.

In a recently updated online fact sheet, the agency said kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

That brought a rebuke from Rep. Mark Pocan (D-WI), who has supported efforts to keep kratom legal. He called the FDA’s position on kratom “extremely antiquated.”

“That update was not much of an update and I think it’s being very unfair to the consumers who are legally consuming kratom in this country,” Pocan told Califf.  “Honestly, there are not only arguable conclusions (in the update), but you are linking to outdated, incomplete and inaccurate information.“

“I hope to come back to you on kratom in a couple months,” Califf replied. “There are millions of people using kratom. We do have real adverse events, real negative things that have happened to people. And it does interact with multiple neurotransmitters.”

Kratom is banned in several states, but a federal effort to ban kratom nationwide in 2016 failed due to a public outcry. The Department of Health and Human Services (HHS) later withdrew an FDA request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused. A former HHS official said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse (NIDA) concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects. NIDA recently had a public hearing on kratom to further explore its therapeutic uses.

“We’ll continue to work with NIDA and we’ll go where the science takes us,” Califf said. “But like I said with regard to cannabis products, we need something different with these kinds of products that are not traditional foods, not traditional drugs.”

Senate Confirms Califf as FDA Commissioner

By Pat Anson, Editor

The U.S. Senate has overwhelmingly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration after months of controversy over his ties to the pharmaceutical industry and criticism of the agency’s regulation of opioid pain medication.

The vote was 89-4 for Califf, a cardiologist and medical researcher at Duke University, who pledged earlier this month to use tougher language in warning labels for extended release opioids and to prioritize development of non-opioid alternatives for pain. Califf also endorsed the CDC’s controversial opioid prescribing guidelines, even though some of the FDA’s own experts believe the guidelines lack scientific evidence.

"If addiction to opioids and misuse of opioids is the enemy, then we underestimated the tenacity of the enemy," Califf told The Associated Press after his nomination was confirmed. "We've got to adjust."

Califf was pressured into changing the FDA’s opioid policies after his nomination was held up by Democratic presidential candidate Sen. Bernie Sanders of Vermont, and Sens. Joe Manchin of West Virginia (D) and Ed Markey of Massachusetts (D).

DR. ROBERT CALIFF

Manchin, Markey, Sen. Richard Blumenthal of Connecticut (D) and Sen. Kelly Ayotte of New Hampshire (R) voted against the nomination. Sanders was on the campaign trail and did not vote on the nomination.

"FDA stands for Food and Drug Administration, but over the last 20 years it really stands for ‘fostering drug addiction,' " Markey said in a speech on the Senate floor.

Both Markey and Manchin have vowed to “change the culture” at FDA to combat what they call a “pandemic” of opioid abuse and overdoses.

“I just think he’s the wrong person at this time of need for the position that we need to shake it up,” said Manchin. "The FDA needs new leadership, new focus and a new culture."

Califf founded Duke University’s Clinical Research Institute, which primarily works with and is funded by pharmaceutical companies. He listed over a dozen drug makers in a conflict-of-interest disclosure for a recent article he wrote in the New England Journal of Medicine.

“Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine.  He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public,” said Dr. Stephen Ostroff, the FDA’s chief scientist, who has served as acting head of the agency for the past year.

What Alternatives do Pain Patients Have?

By Pat Anson, Editor

When the Food and Drug Administration last week endorsed the CDC’s controversial guidelines to limit opioid prescribing, the agency promised it would prioritize development of non-opioid alternatives for chronic pain relief.

“We are also working closely with industry and the National Institutes of Health to develop additional alternative medications that alleviate pain but do not have the addictive properties of opioids,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco, who co-authored a “special report” on the FDA's new opioid policies the New England Journal of Medicine.   

“The FDA has approved non-opioid medications for treatment of various chronic-pain syndromes, including gabapentin (Neurontin), pregabalin (Lyrica), milnacipran (Savella), duloxetine (Cymbalta), and others, and a number of promising development programs are in the pipeline. But we need more. The FDA will use all the tools at its disposal to move these alternatives along as expeditiously as possible, while remaining mindful that all medicines have risks.”

The four drugs mentioned by Califf all have mixed track records, and many chronic pain sufferers have told Pain News Network the medications either don’t relieve their pain or have intolerable side effects.

“Gaba (Neurontin) did nothing for me and Lyrica seemed to help a very little with nerve pain but it made me very shaky, as if I drank a gallon of coffee,” wrote Pam Cushion.

“The side effects of Cymbalta were more than I could bear. I got terrible pains in the skin on my upper back and shoulders, and it made me feel downright awful,” said Tracy W.

“As opiate medications are lowered, my Lyrica dosage has gone up. It does have side effects like weight gain and next day fogginess,” wrote Kenneth McKenna. “I look for physicians to use other medicines in a similar fashion, (due to of the opioid restrictions) which may turn out to be a worse problem than the opioids themselves.”

Both Lyrica and Neurontin are coming under scrutiny in the UK because of increasing reports they are being abused by addicts to get high. Since 2012, over 60 overdose deaths in the UK have been linked to pregabalin and gabapentin.

Researchers in British Columbia also recently warned about the limitations of gabapentin, pregabalin, duloxetine, and venlafaxine (Effexor) when used to treat neuropathic pain.

“The best available evidence now indicates that as few as one in ten people can expect much pain relief from these drugs,” said Dr. Aaron Tejani, a Clinical Assistant Professor in the Faculty of Pharmaceutical Sciences and a member of the University of British Columbia's (UBC) Therapeutics Initiative Working Group. “Many people who improve are getting a placebo effect, or would improve in time without any drug treatment.  Others end up sedated, with impaired thinking, balance disturbance, dry mouth, or other side effects that cause more harm than good.”

The drugs may be ineffective for most patients, but Tejani says many doctors continue to prescribe them because of an exaggerated belief in their effectiveness. From 2005 to 2014, the number of British Columbians receiving pregabalin increased by 17 fold, according to UBC Therapeutics. Over three times as many prescriptions for duloxetine were written during that period, while gabapentin prescriptions nearly doubled. The use of venlafaxine, mostly for depression or anxiety, has been stable.

“Increasing evidence suggests that drugs have relatively little useful role for most patients with chronic pain. We should be much more cautious about prescribing them, and warn patients about their side effects,” said Dr. Tom Perry, a Clinical Assistant Professor in the Department of Anesthesiology, Pharmacology and Therapeutics and Chair of the UBC Therapeutics Initiative team.

Califf Nomination Still Stalled

The FDA’s sudden reversal on many of its opioid policies may have been intended to reduce opposition in the U.S. Senate to Robert Califf’s nomination as the agency’s new commissioner. Early indications are that strategy may not have worked.

“I will continue to strongly pressure the FDA to strengthen its oversight of opioid medications and will continue to push for the strongest possible framework for drug approval to ensure that the agency doesn’t simply continue to approve ever stronger and more deadly opioid medications under this new process,” said Sen. Joe Manchin (D) of West Virginia, one of five senators who are blocking Califf’s nomination.

Manchin has been particularly critical of the FDA’s failure on several occasions to accept the advice of its advisory committees, which have been reluctant to support the approval of new opioids. Last week Califf promised to appoint new advisory panels to review every new opioid that doesn’t have abuse deterrent properties.

“I believe the FDA should use the advisory committee’s expert advice for all opioid medications, including abuse-deterrent formulations, which are just as addictive and can be just as deadly as non-abuse deterrent opioids. The FDA also needs to commit to adhering to the recommendations that the advisory committee puts forward,” said Manchin.

Sen. Edward Markey (D) of Massachusetts also believes the FDA policy changes “fall short of what is needed.”

“While this is a good start, even more is required to ensure the FDA’s approval process protects Americans from the dangers of opioid painkillers,” Markey said in a statement. "Whether an opioid is abuse deterrent or not hasn’t prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers. That is why the FDA must change its decision not to seek expert advice about the risks of addiction before it approves abuse-deterrent opioids.”

FDA Endorses CDC Opioid Guidelines

By Pat Anson, Editor

In a move that may have more to do with politics than healthcare, the U.S. Food and Drug Administration has set aside the advice of its own experts by endorsing the CDC’s controversial guidelines for opioid prescribing.

The move is part of several sweeping changes the FDA is making in its opioid policies, including some that the agency has resisted in the past. The most significant change is support for the CDC’s proposed opioid guidelines, which are designed to combat the so-called epidemic of opioid addiction and overdoses.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence. It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Califf’s nomination to be the next Commissioner of the FDA has been held up in the U.S. Senate, in large part by senators who want the FDA to go much further than it has in restricting access to opioid pain medication.  

ROBERT CALIFF, MD

“We need to change the culture of the FDA, and that will not happen if the person at the helm is not a champion who is committed to pushing back against the pressure to continually approve new opioid medications given the significant risks to public health,” said West Virginia Sen. Joe Manchin (D), who has criticized Califf for his ties to the pharmaceutical industry and threatened to filibuster his nomination.

In a news release issued late Thursday, Califf said FDA would “re-examine the risk-benefit paradigm for opioids,” use tougher language in warning labels on extended release opioids, and prioritize development of non-opioid alternatives for pain.  The FDA also promised to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties, one of Manchin's key demands.   

“I was very disappointed that Califf would release a statement like this as talk of blocking his nomination for FDA Commissioner grows in the Senate amid concerns that he was ‘soft’ on a range of issues, including genetically modified salmon, e-cigarettes, and regulation of opioids,” said Anne Fuqua, a chronic pain sufferer and patient advocate.

“I am concerned his desire for career advancement is interfering with the oath he took to ‘first do no harm’ when he became a physician.  This statement is heavily focused on the potential harms of opioids. Though it says they will seek to balance individual and societal risks, it seems that the need to prevent people from making poor choices will be given priority over providing care to individual pain sufferers for whom opioid therapy has proven to be an essential element of care. “

The FDA’s opioid policy changes are further outlined in a “special report” in the New England Journal of Medicine that was co-authored by Califf.

“We will start by launching a broad reexamination of our approach, considering how best to apply existing policies to this problem, which policies need to be improved and updated, and whether new policies must be developed,” Califf wrote.

“Accordingly, we are supporting the CDC’s Guideline for Prescribing Opioids for Chronic Pain. The draft guideline received extensive public comment, and we look forward to participating in the process when the CDC finalizes it soon. We are also supporting the Surgeon General’s efforts to engage the clinical community in a concerted approach to curbing inappropriate prescribing and proactively treating opioid addiction, while reinforcing evidence-based approaches to treating pain in a manner that spares the use of opioids. Until clinicians stop prescribing opioids far in excess of clinical need, this crisis will continue unabated.”

Some of the FDA’s own experts have been highly critical of the CDC’s proposed guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans use opioids daily for chronic pain and many fear losing access to them if the guidelines are adopted.

“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a December meeting of a federal pain research panel. Hertz said the evidence cited to support the guidelines was “low to very low and that’s a problem.” Other panel members said they were “appalled” by the guidelines, calling them an “embarrassment to the government.”

The CDC planned to implement the guidelines last month, but delayed doing so after widespread complaints about its secrecy and lack of transparency during the guidelines' development. The CDC is now reviewing changes to the guidelines recommended by an advisory committee.

“I guess it shouldn't surprise me that the FDA is selling out by endorsing the CDC guidelines,” said Kim Miller, a pain sufferer and patient activist. “Could it be the FDA was not wanting to be made to look irrelevant in light of the CDC taking care of what many see as the FDA’s territory? Either way, it's an extremely gloomy looking horizon if you're a pain patient. Just when you think it can't get any worse, it always does.”

"It is a sad day for chronic pain patients in this country. The unintended consequences of these guidelines will bring about a true epidemic; not the media manufactured so-called epidemic of overdoses from opioids," said Chrystal Weaver, a Florida woman who suffers from Complex Regional Pain Syndrome. "The last figure I heard quoted for veterans taking their life is around 42 per day. When you take away the only tool we have to help lessen the pain from war injuries you'll see that number skyrocket from 42 per day to perhaps 500 per day. It will be the same story for non-veterans as well."

Earlier this week, the Obama administration said it would ask Congress for $1.1 billion in extra funding to help fight the opioid abuse epidemic. Most of the money would be used on expanding addiction treatment programs.