FDA’s 2019 policy and regulatory agenda

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse – from FDA.gov – Feb 2019

I believe this is Mr. Gottlieb’s goodbye to go along with his resignation.

The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced. It remains the biggest public health crisis facing the FDA.

The toll of addiction, in lost lives and broken families, touches every community in America. Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.

I’m surprised that he admits right off the bat that this crisis could have been mitigated if they had acted sooner, though not in the manner he imagines. 

As long as they’re addressing the wrong source of the overdoses, their efforts to reduce opioid medication won’t make any difference in the opioid overdose numbers. Prescribed opioids are not the ones causing overdoses: most involve illicit fentanyl and poly-drug cocktails, not prescribed opioid medication.

These two “opioids” are also used by entirely separate populations: illicit opioids are used and abused by mostly young people while seniors use prescribed opioids to maintain their quality of life as diseases of old age, like osteoarthritis, leave them in permanent pain.

As the opioid crisis has evolved, so has the nature of the threat.

Opioids are still too commonly prescribed and lawful prescriptions still contribute to the development of new cases of addiction.

But illicit opioids are accounting for a sharply increasing fraction of the total exposure to these drugs, and fueling a growing addiction crisis.

Finally, he gives the correct name to the current crisis: it’s a crisis of addiction, not any particular drug.

Within the scope of our work, we’re especially focused on illicit online purchases. The flow of drugs on the surface and dark web has become a significant part of the epidemic relative to prescription opioids.

In that case, why are they still harassing doctors for prescribing medication to pain patients?

To address the evolving nature of this threat, since 2017, we’ve warned a total of 23 networks operating more than 450 websites for illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol and oxycodone.

Cutting off this illicit internet traffic is critical. We’ll continue to pursue all available means of enforcement to stop these online drug dealers.

In 2018 we also took actions to increase our interdiction work in the International Mail Facilities (IMFs).

Specifically, as the nature of this epidemic has evolved to encompass greater flows and use of illicit opioid drugs, we’ve expanded our enforcement efforts to include increased interdiction work aimed at stopping the illegal flow of counterfeit and unapproved prescription drugs, which in numerous cases includes opioids.

This doesn’t sound like a job for the FDA because it’s an enforcement action and the FDA is not an enforcement agency like the DEA is. 

The FDA continues to have a critical and unique role to play in preventing cases of new opioid addiction – helping to reduce avoidable exposure to opioid analgesics and thereby reduce the rate of new addiction.

This is their theory, that exposure to opioids can start an addiction. But we know that’s not really true.

Until now opioids were routinely prescribed after surgeries, and most people who had some kind of surgery needed a few doses of opioids until they healed. I know of several people who had leftover opioids and chose to “keep them around” for emergencies.

It’s only the addiction-obsessed folks that see drug addiction wherever they look. Most people don’t have a problem with opioids, don’t get euphoric or “high” from them, and don’t particularly like how they feel and so avoid taking them when possible. 

In all the decades that opioids were being prescribed for medical pain, there was not mass addiction. Neither was there a high rate of diversion, where the drugs could be found on the street anytime. 

Support Addiction Recovery and Reduce Overdose Deaths

To help those suffering from opioid use disorder, the FDA is prioritizing new efforts to advance the development and use of safe and effective MAT.

This includes new guidance aimed at supporting the development of novel medicines as well as novel medical devices such as digital health tools, advancing new policies to promote the adoption of safe and effective MAT, and working with partner organizations/stakeholders to reduce the stigma associated with MAT.

Almost all of the addiction-recovery industry is centered on the 12-step model and is committed to the belief that addiction requires a spiritual cure and permanent abstinence. 

Unfortunately, for purists, this even includes the proven benefits of medication-assisted therapy.

Research and Innovation in Non-Addictive Pain Treatments

Another critical part of our efforts for 2019 is new steps to promote the development of drugs to treat pain that are not addictive.

I find this extremely unlikely. Because pain is something generated in our brain from nociceptive input, any drug that affects physical pain will also have other effects on perception.

Strengthen Enforcement Against Illicit Opioids

The FDA will continue to strengthen its enforcement activities that target those who unlawfully market or distribute illicit opioids and other unapproved drugs.

We’ll step up our efforts aimed at the interdiction of opioids being illegally shipped into the United States and will continue to increase the number of investigators, both civil and criminal, in the IMFs.

This seems a considerable overlap with the job of the DEA.

Right now, seizures of opioids like fentanyl are typically reported in pounds of drug product seized. But that doesn’t give a full picture of the total amount of drugs that are being illegally shipped into the U.S. because these weight-based measures don’t account for potency.

Some of the drugs being illegally brought into the U.S. may consist of fentanyl premixes ready for pressing into tablets, while others are super-potent formulations of compounds like fentanyl.

By additional testing to develop a chemical profile of more seized samples, we can develop a better picture of the illicit drug trafficking landscape, which can better inform our policy work.

Finally, as part of our effort to clamp down on illicit sales of opioids – which includes our work to close down illegal portals on the internet and expand our presence in the IMFs – we’re also doing more to secure the legitimate supply chain

I’ve been complaining for years about the lax attitude towards all the employees that handle these drugs in all the steps after manufacturing and long before they reach the patients.

Under the DSCSA, manufacturers, repackagers, wholesale distributors and dispensers – which are mainly pharmacies – are all required to have systems and processes in place to quarantine and investigate suspect and illegitimate medications

This action is part of a broader policy effort to improve the security of the drug supply chain and prevent diversion of opioids.

We’ll continue efforts to ensure manufacturers, repackagers, wholesale distributors, dispensers and others responsible for maintaining the supply chain are taking measurable steps under the law to appropriately track and trace opioid medications as these products move through the supply chain, and to respond to incidents involving illegitimate products to protect the public health.

This sort of accountability and tracking should have been in place from the start. Until now, it seems the distribution chain has been left pretty much untouched, and it operates without all the testing and craziness that patients are subjected to when they need drugs like opioids

These are just some of the new steps we’ll advance in 2019 as we continue to confront this crisis. Looking back across modern times, this is perhaps the biggest public health tragedy ever created through the deliberate actions of people.

This is an interesting choice of words, “the deliberate actions of people”. 

I’m not sure what he’s talking about here. Illicit drugs or prescribed drugs, and who are these people who are committing these deliberate actions to get us into this crisis. It sounds like he’s referring to drug dealers.

2 thoughts on “FDA’s 2019 policy and regulatory agenda

  1. Kathy C

    Gottlieb is partially culpable, and he has realized that he was used. Notice he is particularly careful not to expose any of the greedy corporations, or invoke the FTC, which was supposed to be regulating health marketing. It is very clear that the administration is in the pocket of industry interests and profiteers, especially after the E Cig reversal. He can’t even counter the marketing of E cigs to kids, even though we all know that nicotine is not good for children. The JUUL company marketed E Cigs directly to children, and they will fact no penalties. This is unregulated free market capitalism at it’s finest.

    There was no enforcement of laws, the drug industry lobbyists had done away with any restrictions, on marketing opioids, or anything else. The contortions and lies that Perdue perpetuated, are typical of industry greed and the damage they have done to our health, adn what was left of our democracy. https://www.propublica.org/article/richard-sackler-oxycontin-oxycodone-strength-conceal-from-doctors-sealed-testimony

    The reason Oxycontin was dangerous was that it contained much more opiate than the stated dose. This made it very attractive to the addicted, who found a way to release the full potency. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-opana-er-risks-related-abuse
    The company that sold Opana, which they marketed as a “safer alternative” made billions, while the people with addictions easily figured out how to extract the full content of oxymorphone.

    The lies and denial continue, as whatever system we had is completely undermined. The irresponsible, unscientific and dangerous actions of the DEA, FDA, FTC, as they protected industry interests at the cost of public health. They took Oxycontin off the market without one consideration for the number of people who were addicted. The advertised high dollar, but useless “treatment centers” on reality TV, even as the subjects died. There was no more money given to addiction treatment, or behavioral health, for low income people. They created the “drug crisis.” The media misreported it all, focusing on the sensational stores to denigrate the addicted, while conflating pain patients with craven addicts. They ran false narratives about 12 step programs, and lied to the public about faith based programs, charities, that were supposed to fill in for evidence based treatments.

    So many of these thoughtful articles about this topic leave out key facts. The fail to mention how industry interests attacked OSHA, which led to more musculo skeletal injuries, that required opiates, for the long term chronic pain. They left out the profiteers at the device industry, that peddled dangerous devices as an “alternative” to opiates. They left out the fact that many Americans do not have access to healthcare, meaning that treatable conditions are left to get worse, which contributed to long term chronic pain. They also refuse to acknowledge the Epidemic of Despair in our nation. They looted and hollowed out our country, shipped jobs overseas, and left millions of American with no meaningful work, and at the very same time disparaged them.

    What we have here is the cognitive dissonance, that goes along with unregulated “Market Based”, for profit healthcare. This crisis was created by the very system that was supposed to protect us from unregulated corporate greed. Now they have an illegal fentanyl problem, and a well entrenched illegal drug supply network that adapts easily. They have not done one thing to reduce demand, like raise wages or give people hope. The media is still running false narratives to protect their corporate benefactors. They made billions marketing alternatives to opiates, peddling useless or dangerous devices, and denying healthcare to people they claimed were “addicted” legitimate pain patients. There used to be laws in this country, regulating false health claims, yet enforcing the laws and regulations are not profitable for the corporations. The “War On Drugs” failed, it created a militarized supply chain for illicit drugs, led to millions of unnecessary incarcerations and tore apart our society.

    The Impeachment is on TV, it shows how far this nation has fallen, it is an embarrassment. This is the full effect of unregulated out of control market capitalism, and unmitigated greed. The same kind of lies, dirty tricks and dark money groups, allowed opiates to be marketed to a receptive public, in despair, So many laws, regulations and norms had to be undermined or done away with, to get us all here. So many alternative facts, presented as reality.



    Liked by 1 person


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