Fda commissioner histiocytoma dog castor oil scott gottlieb, m.d., on the ongoing efforts to stop the spread of illicit opioids masscentral

The opioid epidemic continues to be one of the greatest histiocytoma dog castor oil challenges facing this nation and the FDA. As we continue to take a range of steps to histiocytoma dog castor oil forcefully confront the opioid crisis plaguing our country, most people think first and foremost about the agency’s work to encourage more appropriate prescribing to decrease exposure histiocytoma dog castor oil to opioids and prevent new addiction, as well as our initiatives to advance innovations in both histiocytoma dog castor oil novel pain therapies and better treatments to help those with histiocytoma dog castor oil opioid use disorder. Our efforts to combat this public health emergency, however, extend also to stopping the spread of illicit opioids and histiocytoma dog castor oil further securing all aspects of the supply chain for legitimate histiocytoma dog castor oil medications, including opioids.

On the illicit drugs front, we’ve worked to increase our enforcement and interdiction work targeting histiocytoma dog castor oil illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international histiocytoma dog castor oil mail facilities (imfs). Tens of millions of packages are estimated to contain FDA-regulated products, and a surprisingly high percentage of these products are illegal. In fact, in recent years, 86 percent of the packages that were suspected of containing histiocytoma dog castor oil FDA-regulated products and were pulled for FDA review indeed contained histiocytoma dog castor oil illegal, illicit, unapproved, counterfeit and/or potentially dangerous drugs. In 2017, the U.S. Postal service processed nearly one half billion international parcels, a volume that has been growing at roughly 50 percent histiocytoma dog castor oil annually. In fact, the USPS office of inspector general reported that 80 percent histiocytoma dog castor oil of the websites providing guidance on how to mail illicit histiocytoma dog castor oil drugs instructed traffickers to use the postal service for shipments.

The FDA also has special agents that are assigned to histiocytoma dog castor oil the imfs who work closely with U.S. Customs and border protection and FDA regulatory staff, who identify and refer suspect shipments, and who, along with the U.S. Department of justice, bring criminal cases to prosecution. These port of entry investigations have proven to be successful histiocytoma dog castor oil in holding criminals accountable, resulting in hundreds of arrests, prosecutions, guilty pleas and convictions. In addition to our work at the imfs, we’re also working with federal partners to conduct criminal investigations histiocytoma dog castor oil targeting the operations of international criminal groups, both public and on the dark web. Every package stopped, every online network shut down and every criminal convicted reduces histiocytoma dog castor oil the risk that illegal and dangerous drugs will get into histiocytoma dog castor oil the hands of unknowing patients.

We’ve also been active in combating the illegal online sales histiocytoma dog castor oil of opioids. Over the last year, the FDA has sent a series of warning letters to histiocytoma dog castor oil online networks, operating at least 70 websites, illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications. Increasingly, patients are going online to illegally buy opioids like vicodin, percocet or oxycontin but are either not receiving what they histiocytoma dog castor oil ordered, or they are simply being scammed out of their money. Last june, the FDA hosted internet stakeholders and thought leaders, government entities, academic researchers and advocacy groups at an online opioid summit histiocytoma dog castor oil to discuss ways to collaboratively take stronger action in combatting histiocytoma dog castor oil the opioid crisis by reducing the availability of illicit opioids histiocytoma dog castor oil online.

Just as critical are the FDA’s efforts to protect patients from exposure to drugs that histiocytoma dog castor oil get into the legitimate U.S. Supply chain that may be counterfeit, stolen, contaminated or otherwise harmful, as well as making sure these same drugs aren’t being diverted for illegal sale. Entities within the supply chain must also comply with the histiocytoma dog castor oil law and do their part to respond quickly and thoroughly histiocytoma dog castor oil when notified of potential counterfeit, stolen or diverted products entering the supply chain. While the U.S. Drug supply chain is among the safest in the world, complacency isn’t an option. Every link in the supply chain must be secure to histiocytoma dog castor oil ensure patient access to safe and effective medicines. We all need to remain vigilant to protect patients and histiocytoma dog castor oil make sure drugs meant for patients aren’t being stolen or diverted. That means accountability throughout the supply chain, including important oversight by the FDA to ensure every entity histiocytoma dog castor oil within the chain is complying with the law.

Today, as part of our work to secure the drug supply histiocytoma dog castor oil chain, we’re announcing that the FDA has issued its first warning histiocytoma dog castor oil letter under the drug supply chain security act (DSCSA) to mckesson corp. For violations highlighted by a concerning tampering incident that involved histiocytoma dog castor oil opioid medications. Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder and high blood pressure. Under the DSCSA, manufacturers, repackagers, wholesale distributors and dispensers – which are mainly pharmacies – are all required to have systems and processes in place histiocytoma dog castor oil to quarantine and investigate suspect and illegitimate medications. These systems must be in place in order to respond histiocytoma dog castor oil rapidly to notifications of illegitimate products and to notify trading histiocytoma dog castor oil partners and the FDA when illegitimate products are discovered. The warning letter to mckesson outlines violations observed during inspections histiocytoma dog castor oil that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in histiocytoma dog castor oil their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition histiocytoma dog castor oil of illegitimate product as the law requires.

In one instance outlined in the letter, mckesson was notified by a pharmacy customer that multiple of histiocytoma dog castor oil their pharmacy locations received bottles that were supposed to contain histiocytoma dog castor oil potent opioid pills. However, once opened, the pharmacies discovered that bottles at three pharmacy locations did histiocytoma dog castor oil not contain the correct medications, and the opioid pills were missing, having been replaced with other non-opioid medications. The pharmacy customer notified mckesson about the discovery of illegitimate histiocytoma dog castor oil products. While mckesson’s internal investigation noted that it was likely the opioid histiocytoma dog castor oil medication was replaced while in their possession or control, mckesson did not sufficiently respond to the notification that they histiocytoma dog castor oil may have distributed illegitimate products. McKesson could not demonstrate that they took efforts to identify histiocytoma dog castor oil or quarantine additional illegitimate products that may have still been histiocytoma dog castor oil in their distribution facilities. Additionally, mckesson did not notify other pharmacy customers who may have histiocytoma dog castor oil received products with the same lot number or national drug histiocytoma dog castor oil code to make them aware of potential illegitimate product in histiocytoma dog castor oil the supply chain. Additional examples are given in the warning letter of similar histiocytoma dog castor oil failures by mckesson to: respond to illegitimate product notifications; quarantine and investigate suspect and illegitimate products; and maintain records as required by DSCSA.

A distributor’s failure to have systems in place to investigate and histiocytoma dog castor oil quarantine suspect and illegitimate products within their control is a histiocytoma dog castor oil violation of the law. But this is even more concerning given that we’re in the midst of a widespread opioid crisis. Opioids that leave the legitimate supply chain could end up histiocytoma dog castor oil being sold illegally, or a patient who was appropriately prescribed these drugs to histiocytoma dog castor oil treat pain may not get the treatment they need or histiocytoma dog castor oil may unknowingly take a medication that’s not meant for them. This may put the patient at risk of side effects histiocytoma dog castor oil or adverse drug interactions. The security of the supply chain, and continued implementation and enforcement of DSCSA, is an important tool in our efforts to ensure that histiocytoma dog castor oil the american public can have confidence in the products they histiocytoma dog castor oil receive, and that illegitimate opioid products do not find their way histiocytoma dog castor oil into the hands of patients.

We’ll continue our efforts to help ensure manufacturers, repackagers, wholesale distributors, dispensers and others responsible for maintaining the supply chain are histiocytoma dog castor oil taking measurable steps under the law to appropriately track and histiocytoma dog castor oil trace medications – including opioids – as they move through the supply chain, and to respond to incidents involving illegitimate products in order histiocytoma dog castor oil to protect the public health. These efforts are critical to protecting patients from exposure to histiocytoma dog castor oil drugs that may be counterfeit, stolen, contaminated or otherwise harmful, as well as making sure these same drugs aren’t being diverted for illegal sale on the black market. With a tighter, closed system, we’ll be able to better detect and prevent the introduction histiocytoma dog castor oil of illegitimate products and enable stakeholders and the FDA to histiocytoma dog castor oil respond rapidly when such products are found.

This is only one of many actions in our comprehensive histiocytoma dog castor oil efforts to combat the opioid crisis. Important work is continuing on our plans to, among other things, re-examine and modernize the FDA’s framework for evaluating the benefits and risks of opioids histiocytoma dog castor oil in the pre- and post-market settings to consider the individual and public health impacts histiocytoma dog castor oil including potential clinical advantages and a product’s potential risks for illicit use or its potential for histiocytoma dog castor oil abuse.

Among the new steps the FDA is taking: the agency is developing, and intends to publish in 2019, new guidance that describes our application of the risk/benefit framework to opioid analgesics, taking into consideration the full range of risks associated with histiocytoma dog castor oil these products, including the risks created by illicit use. As we solicit input from the public later this year, we’ll also ask questions about how the FDA should be histiocytoma dog castor oil evaluating the safety and effectiveness of new opioid analgesics relative histiocytoma dog castor oil to existing opioid drugs that are already on the market, and how that information might relate to our evaluation of histiocytoma dog castor oil the risks and benefits of new products at the time histiocytoma dog castor oil of approval. In addition, we’re also developing new guidance to modernize the development pathway histiocytoma dog castor oil for non-opioid analgesics for the treatment of acute and chronic pain. This new guidance will take the place of our february histiocytoma dog castor oil 2014 analgesic development guidance. The current guidance recommends sponsors to study new analgesic drugs histiocytoma dog castor oil across a range of conditions that caused pain in order histiocytoma dog castor oil to receive broad indications for the treatment of acute or histiocytoma dog castor oil chronic pain. Instead, in the new guidance documents we will encourage more focused histiocytoma dog castor oil drug development. The FDA will identify specific clinical conditions such as certain histiocytoma dog castor oil kinds of post-surgical pain or back pain, to facilitate new analgesics seeking more narrow indications. This can make the development process more efficient and lead histiocytoma dog castor oil to the approval of drugs more carefully tailored to specific histiocytoma dog castor oil patient needs. Among the issues the FDA will also address is how histiocytoma dog castor oil sponsors developing non-opioid alternatives for pain can seek claims that they decrease histiocytoma dog castor oil the use of opioid analgesics.

We’re also in the midst of work to advance the histiocytoma dog castor oil development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain histiocytoma dog castor oil resulting from specific conditions or procedures, as well as advancing requirements for certain packaging (e.G. Unit-dose packs) to limit the number of pills that a patient receives histiocytoma dog castor oil with a single prescription to mitigate the risk of abuse, misuse and diversion.

We remain committed to using our regulatory authority to the histiocytoma dog castor oil fullest extent to address this crisis, including using new authorities granted to the FDA by the histiocytoma dog castor oil substance use-disorder prevention that promotes opioid recovery and treatment (SUPPORT) for patients and communities act, and building on the important work we’ve outlined and are currently undertaking to change the trajectory histiocytoma dog castor oil of this epidemic. As we work to promulgate new policy, ensure compliance with the law, and encourage development of alternative medicines, we expect that companies will continue to do their part histiocytoma dog castor oil to help bring this epidemic under control, including ensuring the integrity of their supply chains.

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 histiocytoma dog castor oil of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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