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The opioid crisis is one of the largest and most complex public health tragedies that our country has ever seen. It remains the biggest public health crisis that the FDA faces. The balance of dependency, in lost lives and broken families, affects all communities in America. Unfortunately, the magnitude of the outbreak reflects many past mistakes and many parties that have missed the opportunity to put an end to the crisis, including the FDA.
At the FDA, we have worked to learn from the mistakes of the past and we intend to ensure that we act with sufficient force to deal with new threats that could prolong this crisis. Addressing the opioid crisis is one of the top priorities of the Secretary of Health and Human Services and the entire administration. The FDA is a key part of this effort.
We are a deliberative and scientific agency. We calibrate our policy and regulatory actions carefully, based on rigorous evidence that can often take months or even years to collect. This sets our golden rule for regulatory decisions. But given the scale of this crisis and its human cost, we are committed to acting faster in the face of new risks. We have changed our approach and are taking a much more aggressive approach to regulation. At the FDA, we are committed to taking faster action on new threats, such as the growing prevalence of illicit fentanyl, which contributes to overdose deaths or the continued prevalence of prescribed prescriptions for too long periods of use. . the clinical circumstances for which they are intended. We have changed the way we approach these problems and intensify our intervention in the area of opioids. In this epidemic, waiting for the accumulation of irrefutable evidence of harm has left us one step back from a crisis that was evolving rapidly, sometimes stealthily, in vulnerable communities too often tragically ignored.
To deal with this crisis differently and more definitively, we have taken decisive action in recent years and other measures are already under way for 2019, and new measures are planned for this year.
We are determined to take this crisis in advance. We do not want to look back in five years, in the face of an even deeper crisis, with the regret that we have taken more forceful steps than we could have taken earlier. All options are on the table. Addressing this crisis is one of the FDA's top public health priorities. With this statement, I want to evaluate some of the actions we have taken and describe the new actions we are going to take.
FDA shares in 2018
Prescribers have a vital role to play and we must ensure that they have essential information about opioids through drug labeling. In the fall, we expanded the requirements of the Risk Assessment and Mitigation Strategy (REMS) to opioid long-acting and long-acting opioid analgesics (ER / LA) to opioid immediate-release (IR) to be used in an outpatient setting. We have also updated the boxed warnings in the labeling of these products to include information about the REMS system.
The REMS program has also been expanded to require, for the first time, that training be made available to all health care providers, including nurses and pharmacists, involved in the management of patients with Alzheimer's disease. of pain (in addition to the doctors who prescribe these products). . The training content has also been expanded to encompass information on the management of acute and chronic pain, the safe use of opioids or other non-opioid or non-drug treatments, as well as information on the treatment of drug addiction and disorders of the use of opioids.
The FDA has also developed new solutions to address the unique risks of opioids, in connection with our request to withdraw Opana ER from the market in 2017. We will continue, if necessary, to take strict regulatory measures to attempt to limit or restrict access to certain medications. , based on a formal assessment of the risks associated with illicit use, as we did in the case of Opana ER with the risk of intravenous abuse. As part of our efforts to consider the risks associated with the illicit use of opioids as part of the way we evaluate the overall risk and benefits of these drugs, we have also worked with Congress to obtain the explicit power of act, where appropriate, on the basis of taking into account these risks. This authority has been included in the Substance Use Disorders Prevention Act, which promotes the recovery and treatment of opioids (SUPPORT) for patients and communities. In 2018, we also opened a dialogue on the potential for evaluating the comparative benefits and risks of new opioids compared to other opioids already on the market. In the future, we have raised the question of whether there should be such a standard for new opioid authorizations in order to provide an advantage over the existing arsenal. We have raised this issue in the context of the approval of the product sufentanil Dsuvia. We plan to continue to evaluate this concept in the questions we will be asking as part of a public list in conjunction with the draft guidance document we will be publishing to modernize the FDA risk assessment framework for risk assessment. and the benefits of opioid medications.
To reduce the rate of new addictions, we must reduce opioid exposure. This means streamlining the prescription, which means not only that we must take steps to reduce the number of opioid prescriptions, but also that when these medications are prescribed, the dosage and duration of the drug will be reduced. use closely match clinical circumstances. and the medical need of the patient. This means that there is no longer prescription of 30 tablets for tooth extraction. To pursue these public health goals, we are working with stakeholders such as the National Academies of Science, Engineering and Medicine to create a scientific framework for the development of evidence-based prescribing guidelines, which provide specific recommendations on the appropriate dosage and distribution of opioids. specific clinical indications (such as outpatient surgeries).
This will help support evidence-based guidelines in areas where they do not currently exist. This report will be ready by the end of 2019. We are also studying product application data, in collaboration with a university partner, to determine if there is sufficient evidence to support the new guidelines. We believe that there are clinical circumstances in which evidence is already sufficient to make evidence-based prescribing recommendations, and we will continue to develop these guidelines.
In 2018, the FDA also continued to work with other federal and state partners on many other changes initiated in recent years to obtain a more appropriate prescription. Streamlining provider prescribing practices remains the cornerstone of our efforts to reduce the rate of new addictions. And reducing the rate of new dependencies is a key part of our overall approach to dealing with this crisis. These combined actions in many federal, state and professional entities have an impact. Since 2015, the estimated number of prescriptions for opioid analgesics dispensed in American street retail pharmacies (which may be the most vulnerable to prescription drug abuse or diversion) has decreased by 24%. Notably, the more potent opioid prescriptions (over 90 equivalents in milligrams of morphine / unit) have dropped even more sharply since 2015, accounting for less than 1% of opioid analgesic units (for example, tablets ) issued in 2018.
Although the appropriate use of opioids from prescription data can not be determined, the risk of overdose has been shown to be closely related to the increase in dose and duration of use. opioid analgesics. Overall, the total number of prescriptions for opioid analgesics peaked in 2012, 145 million in 1997, compared to 260 million in 2012. The total number of total morphine equivalents (MMEs) estimated by prescription was peaked in 2010, at 950 MME, before falling to 905 MME in 2015 However, the rate of overdose deaths continues to increase. This is due in part to the growing abuse of powerful adulterated or illegally manufactured fentanyl products, purchased on online channels and sold as street drugs.
As the opioid crisis has evolved, so has the nature of the threat. Opioids are still too often prescribed and legal prescriptions still contribute to the development of new cases of dependence. But illicit opioids represent a sharply increasing fraction of total exposure to these drugs and fuel a growing crisis of addiction. As part of our work, we are particularly focused on illicit online shopping. The flow of drugs on the surface and on black canvas has become an important part of the epidemic compared to prescription opioids. To address the evolving nature of this threat, we have since 2017 been warning a total of 23 networks operating over 450 websites for the illegal commercialization of potentially dangerous, unapproved and misidentified versions of opioid drugs, including tramadol and oxycodone. Cutting this illegal Internet traffic is essential. We will continue to seek all available means of enforcement to stop these online drug traffickers.
In 2018, we also took steps to increase our interception work at international mail facilities (IMFs). Specifically, as the nature of this epidemic evolved to encompass more and more illicit opioid drugs, we expanded our enforcement efforts to include increased interdiction work to end the flow of illicit opioid drugs. illegal counterfeit and unapproved prescription drugs. includes opioids.
The FDA has expanded the capacity of import operations and made significant investments in our criminal investigation office and in our laboratories, including our forensic chemistry center. These are important investments to help us identify and stop illegal drugs seeking entry into the United States, including through the IMF.
In the last two months, the Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) have made significant progress in ending the activities of sophisticated, bad actors trying to escape. to the FDA at the border.
Among these new steps, we are pleased to announce that we are applying one of the new provisions of Article 3022 of the SUPPORT Act relating to the restriction of the entry of illicit articles containing active pharmaceutical ingredients. This new authority (new Section 801 (u) of the Federal Food, Drugs and Cosmetics Act) allows the FDA to treat illegally imported items as drugs as long as they meet certain requirements – and stop them if necessary – even in the absence of some evidence of intended use. ORA has updated its IMF procedures to support the implementation of this new authority to prevent the entry of illegal drugs into our country. We are also working on new tools to identify API analogues that pose a significant public health problem, to ensure that this important new tool against illicit drugs has the desired effect. The FDA will begin to apply the new 801 (u) authority to any imported product entering the United States by international mail and labeled as being or containing, or resulting from laboratory testing as being, or containing any ingredient identified as having a nutritional problem. public health. These new measures will make our operations in the IMF more effective and help us improve our interdiction work.
By supporting the appropriate prescription, education and labeling of opioids, we are reducing the excessive amounts of opioid analgesics available for abuse or diversion and helping to reduce the rate of new addictions to prescribed opioids. By strengthening our control and control over US online and incoming packages from abroad, we help stem the flow of even more powerful and deadly drugs (such as illegal Chinese fentanyl) and deal with the changing nature of this crisis. By increasing the accessibility of medication-assisted treatment (ART) and reducing the stigma associated with it, we are helping people with addictions to find a sober life in their community.
These are just some of the areas in which we are working to deal with this crisis using all our tools and authorities. We know we have to treat opioids very differently from other classes of drugs, and Congress has supported us in this effort by giving us new, very specific opioid authorities.
FDA shares in 2019
These are just some of the steps we have taken in 2018 to deal with this crisis. In 2019, we plan to take further steps to strengthen these efforts and adapt our response to deal with the changing nature of the threat. We will continue to make new efforts to deal with this tragedy in an aggressive and compassionate way.
Reduce the misuse and abuse of opioid drugs
The FDA continues to play a pivotal and unique role in preventing new cases of opioid addiction – helping to reduce preventable exposure to opioid analgesics and, therefore, reduce the rate of new addictions.
We are taking further steps to reduce exposure to opioid analgesics by ensuring that these medications are properly prescribed, with the dosage, amount and duration of treatment that corresponds to the indication. The promulgation of the SUPPORT Act has provided the FDA with important new authorities to help us reduce the risk of addiction and abuse associated with opioid analgesics. For example, the new law allows the FDA to require the availability of certain packaging for opioids and other drugs with a serious risk of abuse or overdose if it determines that such packaging can mitigate these risks. We plan to implement the initial steps requiring a dose packaging unit in the first half of 2019. More specifically, the FDA plans to use this new authority to require certain solid oral dosage forms of immediate release of opioid analgesics indicated the treatment of acute pain be available in short-term packaging for dispensing outpatient. Such packaging could reduce over-prescribing by offering providers a convenient option containing only enough doses of medication for opioid treatment up to a few days at the standard dose. Our data suggest that for many indications of acute pain where opioids are used, a day or two of distributed medication is the appropriate amount. Small amounts in blister packs, which suggest that a day or two of medication is enough, could reduce the total amount of drugs dispensed available for inappropriate, abusive and misused use.
The SUPPORT Act also allows the FDA to require manufacturers to develop disposal technologies (such as flip bags) to extract unused drugs from medicine cabinets. This is another new authority we are prioritizing for the first half of 2019.
We are also taking further steps to consider a framework for formally evaluating each opioid candidate in the context of how a new opioid could fit into the overall therapeutic arsenal available to patients and providers, and respond to the question we are frequently confronted with. asked whether new opioid drugs should offer a comparative advantage over existing drugs. This process could include the request for revisions of statutory authorities to allow us to change the weight we attach to a significant therapeutic differentiation of proposed new opioids, including safety or efficacy benefits through compared to existing treatments.
We also plan to continue our efforts to continue to evaluate the effectiveness of REMS programs for opioid products, including data collection methods and assessment tools. Recently, we have heard concerns about the REMS program associated with a class of opioid products, fentanyl immediate-release transmucosal (TIRF) drugs, and whether the REMS program was working as expected. This is a topic that was raised by the FDA at a public advisory committee meeting in August 2018.
These products are medically important for a specific group of patients with acute pain that may not be managed by an opioid analgesic available 24 hours a day. But these drugs also pose serious risks. This is why the agency has made efforts to ensure that the TIRF REMS program achieves its public health goal of ensuring safe use and mitigating the risk of abuse. abuse, addiction, overdose and complications due to medication errors. The agency has actively evaluated the recommendations of our advisory committee on the effectiveness of the REMS and the necessary changes. Based on these recommendations and our analysis of our own data, the FDA will soon communicate next steps, including changes to strengthen the current REMS TIRF system. The prescription of TIRF products has significantly decreased compared to the peak years of 2014 and 2015. Nevertheless, substantial risks remain if these potent drugs are not used properly and in the indicated patients. The changes we will make to the TIRF REMS programs will aim to ensure that the program is committed to mitigating the known risks of these drugs and that these drugs are only prescribed for opioid-tolerant patients, and that these patients understand risks and how to use TIRF drugs safely.
Help addiction recovery and reduce the number of overdose deaths
To help people with opioid use disorder, the FDA prioritizes new efforts to advance the safe and effective development and use of MAMs. This includes new guidelines to support the development of new medicines as well as new medical devices such as digital health tools, to advance new policies to promote safe and effective MAM adoption, and to work with organizations partners / stakeholders to reduce the stigma associated with TAPIS.
Reducing the number of overdose deaths also requires expanding the availability of naloxone. One potential way to improve access to naloxone is to make it available for cash sales. The FDA-approved versions of naloxone currently require a prescription, which can be a barrier for people who are not treated by a doctor or who fear stigma associated with seeking access to the drug or who fear to admit their addiction problems. . Having widely available naloxone, for example as an FDA-approved OTC product, would be an important step forward for public health and a need we are already working on at the FDA.
To encourage naloxone manufacturers to enter the over-the-counter market, the FDA has taken an unprecedented step in developing a label template containing drug pictograms that contain easy-to-understand pictograms. We have proactively designed, tested and validated the essential labeling requirements to approve an OTC version of naloxone and make it available to patients. These steps place in the public domain much of the regulatory work required to take over-the-counter naloxone. One of the key components of over-the-counter availability is now in place, which allows sponsors to use it to gain approval for the over-the-counter naloxone and improve their use. access. These efforts should boost the development of over-the-counter naloxone and promote wider access to this drug. This year, we are looking to work with industry partners interested in developing these over-the-counter naloxone products.
Research and innovation in the treatment of pain without addiction
Another essential part of our efforts for 2019 is new measures to promote the development of non-addictive pain medication. To achieve these goals, we will publish updated guidelines in 2019 setting out the evaluation criteria and appropriate clinical approaches for the development of non-opioid drugs for the treatment of acute and chronic pain. We will also advance new steps to promote the development of opioid-dissuasive formulations of abuse by exploring new methods of analyzing and evaluating the deterrent characteristics of abuse. ; further evaluate the nomenclature used to describe these deterrent characteristics of abuse; and facilitate the development of science for generic versions of these products.
Strengthen the fight against illicit opioids
The FDA will continue to strengthen its enforcement activities targeting people who illegally market or distribute illicit opioids and other unapproved drugs. We will intensify our efforts to ban opioids illegally imported into the United States and continue to increase the number of civilian and criminal investigators within the IMF.
Among the new measures we will take in 2019, the FDA is working in partnership with the US Customs and Border Protection (CBP) to expand information sharing and optimize inspection and reporting capabilities. detection of each agency at the border to protect the public from illegal and potentially harmful activities. products entering the United States. This includes real-time sharing of data obtained by scientists using field-based screening tools to test samples seized at MFIs and at the border. We work closely with our CBP partners as part of this program.
At the present time, opioid seizures like fentanyl are usually reported in seizure drug records. But that does not give a complete picture of the total amount of drugs that are illegally exported to the United States, because these weight-based measures do not account for the activity. Some of the drugs introduced illegally in the United States may consist of fentanyl premixes ready to be pressed into tablets, while others are extremely potent formulations of compounds such as fentanyl. By conducting additional tests to develop a chemical profile of the seized samples, we can paint a more complete picture of the illicit drug trafficking landscape, which could better inform our political work.
We will also expand our collaboration with Internet stakeholders to combat illicit drugs sold online. In April, we are also hosting our second opioid summit online. The first Opioids Online Summit, held last June, initiated an open and frank dialogue with key Internet stakeholders to discuss ways to take aggressive action to reduce the availability of opioids online. Since the announcement of the initial summit, internet stakeholders have taken concrete steps to prevent the illegal sale of opioids through their platforms and their services. This collaborative dialogue with key stakeholders has led to important actions.
For example, Google is now de-indexing websites based on our warning letters that cite the illegal sale of opioids to US consumers. Social media platforms such as Facebook and Instagram are redirecting users looking to buy opioids online to the national helpline for the administration of addiction and mental health services. We look forward to the second Opioid Online Summit, which will build on these efforts by proposing additional innovative measures to protect the public against opioids sold illegally over the Internet.
As part of the 2019 budget, the FDA also received $ 20 million to create a large-scale data warehouse to improve its analytical capabilities and better assess the social and clinical trends that affect the organization. trajectory of the opioid crisis. This warehouse can facilitate data analysis, including machine learning algorithms, to better assess population vulnerability points through predictive analysis, identify early trends that may contribute to the analysis Epidemic and target the first regulatory changes to deal with the evolution of the epidemic opioids.
Finally, as part of our efforts to combat the illicit sales of opioids – which include our work to close illegal Internet portals and strengthen our presence at the IMF – we are also doing more to secure the legitimate supply chain. It means doing more to ensure that distributors are held accountable for securing the drug supply chain. As part of this effort, we recently announced that the FDA had sent to McKesson Corp. its first letter of warning under the Drug Supply Chain Security Act for violations highlighted by an intrusion incident involving opioid drugs . Under the DSCSA, manufacturers, repackaging companies, wholesalers and distributors – who are primarily pharmacies – are all required to have systems and processes in place for quarantining and investigating suspicious and illegitimate drugs. Ces systèmes doivent être en place pour réagir rapidement aux notifications de produits illégitimes et pour informer les partenaires commerciaux et la FDA lorsque des produits illégitimes sont découverts. La lettre d'avertissement à McKesson souligne les violations constatées lors des inspections de l'été dernier, notamment le fait de ne pas: répondre suffisamment aux notifications indiquant qu'il y avait des produits illégitimes dans leur chaîne d'approvisionnement; mettre en quarantaine et enquêter sur les produits suspects; et tenir des registres des enquêtes sur les produits suspects et de l'élimination des produits illégitimes, conformément à la loi. Cette action s'inscrit dans le cadre d'un effort politique plus large visant à améliorer la sécurité de la chaîne d'approvisionnement en médicaments et à prévenir le détournement d'opioïdes. Nous poursuivrons nos efforts pour veiller à ce que les fabricants, les réemballeurs, les distributeurs en gros, les distributeurs et les autres responsables de la maintenance de la chaîne d'approvisionnement prennent des mesures mesurables en vertu de la loi pour suivre et retracer de manière appropriée les médicaments opioïdes au fur et à mesure de leur progression dans la chaîne incidents impliquant des produits illégitimes afin de protéger la santé publique.
Ce ne sont là que quelques-unes des nouvelles étapes que nous franchirons en 2019 pour faire face à cette crise. En regardant à travers les temps modernes, il s’agit peut-être de la plus grande tragédie de santé publique jamais créée par des actes délibérés de personnes. La crise des opioïdes s’est installée au cours de décennies d’action et d’inaction. Maintenant, sa portée est si vaste et si dévastatrice que son bilan est évident. Malheureusement, il faudra des années d'action agressive pour inverser son cours pour de bon. Nous ne perdrons pas notre attention sur ce combat.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. L’agence est également responsable de la sécurité des produits alimentaires, des cosmétiques, des compléments alimentaires, des produits émettant des radiations électroniques et de la réglementation des produits du tabac.
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