Trump’s FDA Chief Takes Wide Aim at Opioid Addiction Crisis
The Food and Drug Administration, as part of a sweeping overhaul in how it regulates opioid painkillers, plans to look to some unusual allies to limit the flood of the addictive pills — health insurers and companies that manage prescription drug benefits.
Food and Drug Administration Commissioner Scott Gottlieb plans to meet in September with the benefit payers and insurance administrators, groups the FDA hasn’t typically worked with in its role as a drug regulator. The plan, Gottlieb said, is to stem the tide of addiction to the pills by limiting the number of people exposed to them in the first place.
“Most people who become addicted to opioids are medically addicted,” Gottlieb said in a wide-ranging interview with Bloomberg in New York. “The way to reduce the rate of new addiction is to reduce the rate of exposure, and the way to reduce the rate of exposure is to make sure people are receiving prescriptions when it’s only medically appropriate.”
Gottlieb, who was picked by President Donald Trump earlier this year to lead the agency, said he views it as part of his mandate to tackle the opioid crisis, as well as other issues such as drug costs. The sessions with insurers and pharmacy managers will be his first official meetings with health-care companies, he said. The agency doesn’t have regulatory authority over insurance companies, which are largely overseen by state regulators or other departments within the Health and Human Services Department.
Millions of Pills
More than 240 million opioid prescriptions were dispensed in the U.S. in 2014, according to the Department of Health and Human Services. Deaths from opioid pain pill overdoses in 2015 totaled almost 23,000 in the U.S., double the number a decade ago, according to the National Institute on Drug Abuse.
Gottlieb said he wants to examine whether insurers and pharmacy benefit managers, or PBMs, can reduce the number of pills dispensed. That could involve changing drug labels or requiring doctor education for longer prescriptions.
“There shouldn’t be 30-day prescriptions for a tooth extraction, or 30-day prescriptions for a hernia repair,” Gottlieb said.
Gottlieb, 45, served in several senior positions at the FDA during the George W. Bush administration. He’s also worked as an adviser to investment firms and as a fellow at the conservative-leaning American Enterprise Institute, a Washington think tank.
“I’m looking at different models that could potentially be less burdensome but be more effective at achieving the goal of making sure that prescribing conforms more closely with clinical guidelines,” Gottlieb said. “They’re not in there right now. There’s no information in the drug label about what the appropriate dispensing should be.”
Opioid Mandate
Gottlieb said that he’s altered the FDA’s focus on certain issues since he was confirmed as commissioner in May, but the agency’s opioids policy has been the biggest change in focus.
“Coming out of the confirmation process, I had a mandate to try to steer the agency in a little bit of a different philosophical direction,” he said. “I talked to 65 senators who all wanted to see the agency act differently.”
In a first, the FDA in June asked Endo International Plc to pull its opioid Opana ER from the market. Endo has since agreed to stop sales of the painkiller that became a favorite of people abusing such drugs and led to a serious outbreak of HIV and hepatitis C linked to shared needles used to inject crushed versions of the drug.
The move marked a shift in FDA policy to consider how opioids are used not just by appropriate patients but also by people addicted to the pills.
“We’re constantly looking retrospectively to what’s on the market and making sure that it still makes sense relative to today’s marketplace and what’s available,” he said.
Gottlieb said the agency will keep looking at how drugs that are already on the market are used, in both medical settings and also illicit ones.
“It’s like I said on the drug pricing thing, there’s no silver bullet,” he said. “There’s not going to be one thing that we’re going to do. We’re going to be doing a long list of things.”
https://en.wikipedia.org/wiki/Scott_Gottlieb
If you read Dr Gottlieb work experiences… it would appear that once he completed his internal medicine residency.. he did little/no further “practicing medicine”. Since the FDA is going in the direction of overseeing/influencing the utilization/treatment of subjective diseases ( pain, anxiety, depression, ADD/ADHD, mental health) having someone “at the helm” of the agency… that has little hands-on experience and must depend on their “book smarts” which can be biased by the author of the academic books and/or the biases of professors/instructors… which could have been developed in the “vacuum” of little/no hands-on clinical experience.
Just look at the numbers in this particular article… 240 million opiate prescriptions and 100+ million chronic pain pts would suggest that each chronic pain pts.. could now be getting TWO PRESCRIPTIONS PER YEAR ???
240 million opiate prescriptions and a total of 4.5 billion total prescriptions/yr… suggests that abt 5% of all prescriptions are for OPIATES ?
Dr Gottlieb in the above wikipedia link … The nominee testified before Committee on Health, Education, Labor and Pensions (HELP).[24] There, Gottlieb equated the spread of opioid addiction with the previous epidemics of Ebola and Zika virus. So apparently Dr Gottlieb believes that addiction/substance abuse should be considered the same as a EPIDEMIC from a CONTAGIOUS DISEASE(s) ?
Apparently Dr Gottlieb has not made himself familiar with the statement from our previous Surgeon General that addiction(s) is a mental health disease and not a moral failing http://www.huffingtonpost.com/entry/vivek-murthy-report-on-drugs-and-alcohol_us_582dce19e4b099512f812e9c It would be nice for the head of the FDA to be “up to date” on current beliefs on the real cause of addiction
Filed under: General Problems
1. If these 23,000 died from overdose, (that means the ingestion or application of a drug or other substance not recommended )So if the doctor recommended that they take such a large dose then the doctor is at-fault if the patient took to many of his pills and didn’t take his prescription as perscribed then it’s the patient’s fault that they died how can an inanimate object – the pain pills be at fault for an action perform by a human, those pills didn’t just hop in their mouth and run down their throat and into their system they knowingly and willingly took an excessive amount of their prescribed medication for the soul purpose of either they decided it was time to stop the pain the only permanent way it can be stopped or they took an excessive amount of the prescribed medication trying to get higher than the last time they took an excess amount of the prescribed medication and death resulted.
What planet is he from? 30 scripts for teeth, I’ve never gotten that. The problem is people making rules when they have no freaking clue what they are talking about
One more thing – When I first learned the DEA was going to reschedule hydrocodone as a II, I told anyone who would listen to me that within two years of that, heroin rates will skyrocket because many people in severe chronic pain will be unable to access hydrocodone or any other II and would become desperate for just a little relief. I just didn’t realize how much the rates would skyrocket. Mark my words – this will backfire, as all of this excessive legislation has, and explode in their face. If they think the heroin and alcohol use rates, along with the suicide rates, are bad right now, they haven’t seen nothing yet.
It was only a few years ago when the little Nazi Gottlieb wrote an article stating that the government needs to be careful about interfering with doctors’ ability to prescribe pain medications to their patients, most importantly their chronic pain patients. I wonder how much money it took to bribe him into doing a 180 on his beliefs …
At this rate, they might as well establish standard meds and dosages for every dam medicine there is! Those with long term pain are the only ones who get 100% cookie cutter medicine, yet pain comes from a multitude of injuries and illnesses, many different types of pain and severity. So, let’s start giving the same dose of penicillin to every man, woman and child for infection, no matter what. One blood pressure med, same dose for all, one diabetic med, same dose for all… but if they are overweight, then let’s say they are abusing it and take it away. One cancer treatment per cancer patient, same dose. No I do not want all that, but stating how long a post op patient gets meds, or how long one with chronic illness gets meds is the same thing. Shoot me now.
Well said!!
I worry his “scope” may be too wide.He mentions they need to make sure people receiving prescriptions do so only when medically appropriate.Isnt that what they should be doing? But they need the doctors to determine when it’s medically appropriate,not the FDA or DEA,or politicians.
He also mentions hernia repair.I had one done just about 30 days now,and I’m still in pain.Who will determine what is appropriate?I have been treated with hydrocodone for 7 years now for medical conditions that have left me disabled and in constant pain.Ive used the exact same amount for years now,40 mill.per day.Ive never abused or misused.They increased the amount to 40 mill. about 4 years ago.It has been deemed medically appropriate for my condition of continual pain and disability,yet every time my clinic changes doctors,I have the stress concerning if the new doc will continue the treatment.
He mentions a 30 day limit after hernia repair.I don’t know about others,but I do know in my case My monthly prescriptions for my condition,have been very helpful with the extra pain from the hernia repair,and 30 limit would not be sufficient for the pain I still suffer 30 days later.So who determines what amount is necessary for each patient? This is how many become Undertreated,but also how many lie and become abusers.It is a fine line,and should be left to the doctors to make those decisions.If the doctors are being pressured and become fearful to prescribe,people will suffer as a result of that.The need to prevent addictions in some,will be harmful for others who will be Undertreated,or not treated at all.