Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives

Chairman Walden and Ranking Member Pallone, thank you for the opportunity to testify today before the full committee.

The epidemic of opioid addiction that’s devastating our nation is the biggest crisis facing public health officials, FDA included.

As this crisis grew, many of us didn’t recognize the consequence of this threat. We missed opportunities to stem its spread. So we find ourselves at a tragic crossroad.

We have a crisis of such massive proportion that the actions we need to take are going to be hard.

We’ll need to touch clinical practice in ways that may make certain parties uncomfortable. This may include such steps as restrictions on prescribing, or mandatory education on providers. Long ago, we ran out of straightforward options.

At FDA, we’re working across the full scope of our regulatory obligations to impact this crisis.

That means updating and extending the risk management plans and educational requirements that we impose on sponsors as a condition of a product’s approval.

It means doubling our efforts to promote the development of new, less addictive pain remedies; as well as opioids that are harder to manipulate and abuse.

It means updating our risk-benefit framework to take measure of the risks associated with misuse and abuse of opioids; and using this information to inform our decisions — including recommending that products be withdrawn from the market.

These steps and others are needed to prevent new addiction.

But given the scale of the epidemic, with millions of Americans already affected, prevention is not enough.

We must also help those who are suffering from addiction by expanding access to lifesaving treatment.

I’d like to announce three new steps towards this goal today.

First, FDA will issue guidance for product developers as a way to promote the development of new addiction treatments.

As part of this guidance, we’ll clearly lay out our interest in the development and use of novel, non-abstinence-based endpoints as part of product development. We’ll also aim to make it easier to develop new products that address a fuller range of the symptoms of addiction such as craving.

Second, FDA will take steps promote the more widespread use of existing, safe and effective, FDA approved therapies to help combat addiction. There are several FDA approved treatments. All of these treatments work in combination with counseling and psychosocial support. Everyone who seeks treatment deserves the opportunity to be offered all three options as a way to allow patients and providers to select the treatment best suited to the needs of each individual patient.

How do we know that medications work?

To start, the FDA approval process requires that all products demonstrate that they are safe and effective prior to approval.

The evidence base then grows significantly after approval.

Unfortunately, far too few people who are addicted to opioids are offered an adequate chance for treatment that uses medications. In part, this is because insurance coverage for treatment with medications is often inadequate.

To tackle the treatment gap, FDA is planning to convene experts and stakeholders to discuss the evidence of treatment benefits at the population level – such as studies that show community wide reductions in overdose following expansion of access to therapy. We will also discuss the potential for further research to assess the value of these medications in the context of today’s overdose epidemic.

There’s a wealth of information supporting the use of these medications. We’re focusing on the data in the drug labeling that can help drive broader and appropriate prescribing. So one concept that FDA is actively pursuing is the research necessary to support a label indication for medication-assisted treatment for everyone who presents with an overdose, based on data showing a reduction in death at a broader population-level. Such an effort would be a first for FDA. We believe that granting such an indication in labeling can help promote more widespread use of, and coverage for these treatments.

Why is it important to promote the value of these treatments at the population level? Here’s an example. Recently, the Commonwealth of Massachusetts found a greater than 50 percent reduction in the risk of death from overdose among individuals treated with methadone or buprenorphine after a nonfatal overdose. These kinds of data have immense implications for insurers and policymakers in deciding how to adopt these treatments.

A common question that arises with treatment is the proper duration of medication therapy. Clinical evidence shows that people may need treatment with medications for long periods of time to achieve a sustained recovery. Some may even need a lifetime of treatment. Recognizing this, the FDA is revising the labels of these medical products to reflect this fact.

Now I know this may make some people uncomfortable. That’s why the third step I’m announcing today is that FDA will join efforts to break the stigma associated with medications used for addiction treatment. This means taking a more active role in speaking out about the proper use of these drugs.

It’s part of our existing public health mandate to promote the appropriate use of medicine. Misunderstanding around the profile of these products enables stigma to attach to their use.

This stigma serves to keep many Americans who are seeking a life of sobriety from reaching their goal. In this case, in the setting of a public health crisis, we need to take a more active role in challenging these conventions around medical therapy.

The stigma reflects a view some have; that a patient is still suffering from addiction even when they’re in full recovery, just because they require medication to treat their illness.

This attitude reveals a flawed interpretation of science. It stems from a key misunderstanding many of us have of the difference between a physical dependence and an addiction.

Because of the biology of the human body, everyone who uses opioids for any length of time develops a physical dependence—meaning there are withdrawal symptoms after the use stops. Even a cancer patient requiring long-term treatment for the adequate treatment of metastatic pain develops a physical dependence to the opioid medication.

That’s very different than being addicted.

Addiction requires the continued use of opioids despite harmful consequences. Addiction involves a psychological craving above and beyond a physical dependence.

Someone who neglects his family, has trouble holding a job, or commits crimes to obtain opioids has an addiction.

But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving more or harming themselves or others is not addicted.

The same principle applies to medications used to treat opioid addiction. Someone who requires long-term treatment for opioid addiction with medications – including those that cause a physical dependence — is not addicted to those medications.

Here’s the bottom line:

We should not consider people who hold jobs, re-engage with their families, and regain control over their lives through treatment that uses medications to be addicted.

Rather, we should consider them to be role models in the fight against the opioid epidemic.

Committee members, we need to embrace long-term treatment with proven therapies to address this crisis. At FDA, we will step up our efforts to do our part to promote these goals.

I look forward to discussing these issues with the committee. And I’m grateful for the opportunity to be here.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

13 Responses

  1. So much bull crap! As 450,000 die every year from cigarettes and they are legal! And not one voice of concern! The CDC and as we know the present Criminal Regime in power now is pumping more crap into us!

  2. Lord help us. Again all about addiction getting treatment.
    I can’t.

  3. Addiction has very little to do with the Substance being abused. The substance (x) could be anything…

    “Is a deck of cards addicting?”
    Gabor Mate


    These things are abused by a relatively small percentage of the population. It isn’t the duty of government regulators to “double down.”

    We don’t blame Budweiser for alcoholism and we don’t blame Krispy Kreme for obesity.

    There is a human variable called choice that comes into play here.

    Take one substance away (let’s say it’s alcohol) and the person goes to AA. What I’ve observed over 35 years is they just start abusing sugar, food or cigs, caffeine at or after AA meetings.
    The addiction doesn’t just magically go away because the substance has been removed.

    The substance is simply the thing used to ESCAPE from feelings of helplessness or anger or whatever it is one does not want or simply can’t deal with.

    Why can’t these people grasp addiction is so much more than just the drug???

    • Well said. But their jobs are more important and for us they are completely impotent. Now the AG need opiates to appear as “bad” on all occasions or they won’t get paid. And they will not turn around, not now. What HHS said about making sure that those who need them get them is a great example of impotence.

    • …paid as easily or as much, that is the AGs – and their bought ‘investors’, the Media, CDC and the DEA, seems the FDA will be onboard to me in a bigger way than just maintaining silence very, very soon since Gottlieb got the boot for no apparent reason, a puppet is coming in to move this along before they get to old to enjoy it.

    • Amen!! This is a mental health issue and it will never be resolved until we as a Nation begin to recognize it for what it is, Mental Health!

  4. In the little bit he said bout dependence not addiction was great explaining about how pain patients lives get better and addicts lives get worse is very true. But like always its all bout addicts not who is really being impacted by this made up crisis.

  5. “We’ll need to touch clinical practice…..”
    It means interfere and restrictions to patients in pain.

    They promoting MAT, in other words just give all the opioid medication to the diagnosis addicts that they want. Seems like ultimately there could be millions of people whether addicts or not, that will be prescribed this opioid-based addiction treatment.

    I sense these same millions of people could literally be transformed into a very willing Army that could easily be controlled by whoever ends up in control of the top regulating Authority.

    The ststement said that one should be prepared for a lifelong need for this medication-assisted treatment. I wonder if we are being buttered up to look the other way as a substantial size group of subjects are being groomed to do the will of ???.

    Sounds kind of like Science Fiction but the whole program is so bizarre and not really necessary that it makes one Wonder.

    Besides, is this “effort” talking about a target group of pain patients that end up with addiction behavior? Such a group would then be absorbed into this new “program”?
    We are told that this group of addicted patients may be around 1% of total pain patients!
    They are going to have to round up another group to fill the ranks. Wonder who?
    History repeating itself.

    All of this and the resources too for such a small group, while not even mentioning the beneficial properties of opioids as medicine. What’s going on here?

    “Never let a good crisis go to waste” unknown, to me anyway. Whose?

  6. Isn’t it interesting that addicts can have medications to maintain jobs and relationships- but chronic pain patients CAN’T.

  7. Little sell out scum bag shit stain.

  8. Once again, it’s all about the addicts and eliminating opioids. No mention of the people who suffer with chronic debilitating pain.

    • Marie;
      Actually there is a bit –a very, very tiny bit: “Because of the biology of the human body, everyone who uses opioids for any length of time develops a physical dependence—meaning there are withdrawal symptoms after the use stops. Even a cancer patient requiring long-term treatment for the adequate treatment of metastatic pain develops a physical dependence to the opioid medication.” He goes on to say that dependence is not evil…what counts as a brave & bold stance these days.

      This I agree is way too little, way too late, & ignores the monstrous crimes being done against pain patients, but the mere fact that the guy admits that physiological dependence & addiction are very different is a huge improvement over Kolodny, Ballentyne, & the rest of their ilk’s propaganda….which has metastasized into public perception & down to some doctors’ offices (including my own; he thinks Ballentyne is a genius, God help me).

      nearly nothing, i realize, but there is so little facts in official publications nowadays it’s somewhat comforting to see a bit of fact. I’m sorta reaching here, I know.

    • Amen. Karma is a Bitch! I want to be able to learn of each and every one of these “Healthy Jackasses” who, and odds are imminent, they too will soon face unasked for forever life changing health issues that will leave them to be forced to live a life, suffering from EXCRUCIATING daily Chronic pain, and willing admit they will be able to have a comfortable quality of life by effing meditation and Tylenol. They better wake up and smell the cacah..because they’ll be crying in agony like little bitches! The human body (brain) was designed, having Opioid Receptors. Meaning, opioids were to created to soothe the human body of debilitating pain. It’s a test! A test to see if one can use Opioids for the relief of pain..NOT ABUSE THEM! ABUSE THEM, YOU DIE OF OVERDOSE! USE THEM RESPONSIBLY YOU ARE AWARDED A LIVABLE, QUALITY OF LIFE! VERY SIMPLE, YOU MORONS!!

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