Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

SILVER SPRING, Md., Feb. 12, 2019 /PRNewswire/ -- The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA. As we continue to take a range of steps to 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 to opioids and prevent new addiction, as well as our initiatives to advance innovations in both novel pain therapies and better treatments to help those with opioid use disorder. Our efforts to combat this public health emergency, however, extend also to stopping the spread of illicit opioids and further securing all aspects of the supply chain for legitimate medications, including opioids.

On the illicit drugs front, we've worked to increase our enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international 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 FDA-regulated products and were pulled for FDA review indeed contained 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 annually. In fact, the USPS Office of Inspector General reported that 80 percent of the websites providing guidance on how to mail illicit drugs instructed traffickers to use the Postal Service for shipments.

The FDA also has special agents that are assigned to 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 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 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 the risk that illegal and dangerous drugs will get into the hands of unknowing patients.

We've also been active in combating the illegal online sales of opioids. Over the last year, the FDA has sent a series of warning letters to 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 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 to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online.

Just as critical are the FDA's efforts to protect patients from exposure to drugs that 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 law and do their part to respond quickly and thoroughly 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 ensure patient access to safe and effective medicines. We all need to remain vigilant to protect patients and 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 within the chain is complying with the law.

And I want to be clear, the FDA won't hesitate to act when companies violate the law and jeopardize the safety of Americans by neglecting their responsibilities to maintain the security of the supply chain, especially when it comes to opioids.

Today, as part of our work to secure the drug supply chain, we're announcing that the FDA has issued its first warning letter under the Drug Supply Chain Security Act (DSCSA) to McKesson Corp. for violations highlighted by a concerning tampering incident that involved 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 to quarantine and investigate suspect and illegitimate medications. These systems must be in place in order to respond rapidly to notifications of illegitimate products and to notify trading partners and the FDA when illegitimate products are discovered. The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires.

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

This is simply unacceptable.

A distributor's failure to have systems in place to investigate and quarantine suspect and illegitimate products within their control is a 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 being sold illegally, or a patient who was appropriately prescribed these drugs to treat pain may not get the treatment they need or may unknowingly take a medication that's not meant for them. This may put the patient at risk of side effects 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 the American public can have confidence in the products they receive, and that illegitimate opioid products do not find their way 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 taking measurable steps under the law to appropriately track and trace medications – including opioids – as they move through the supply chain, and to respond to incidents involving illegitimate products in order to protect the public health. These efforts are critical to protecting patients from exposure to 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 of illegitimate products and enable stakeholders and the FDA to respond rapidly when such products are found.

These steps complement our enhanced enforcement and interdiction activities aimed at drugs such as illicit opioids being shipped illegally through the IMFs and our crackdown on illegal online sales. We'll continue to hold all parties accountable for further securing the U.S. drug supply chain and stopping the spread of illicit drugs.

This is only one of many actions in our comprehensive 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 in the pre- and post-market settings to consider the individual and public health impacts including potential clinical advantages and a product's potential risks for illicit use or its potential for 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 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 evaluating the safety and effectiveness of new opioid analgesics relative to existing opioid drugs that are already on the market, and how that information might relate to our evaluation of the risks and benefits of new products at the time of approval. In addition, we're also developing new guidance to modernize the development pathway for non-opioid analgesics for the treatment of acute and chronic pain. This new guidance will take the place of our February 2014 analgesic development guidance. The current guidance recommends sponsors to study new analgesic drugs across a range of conditions that caused pain in order to receive broad indications for the treatment of acute or chronic pain. Instead, in the new guidance documents we will encourage more focused drug development. The FDA will identify specific clinical conditions such as certain 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 to the approval of drugs more carefully tailored to specific patient needs. Among the issues the FDA will also address is how sponsors developing non-opioid alternatives for pain can seek claims that they decrease the use of opioid analgesics.

We're also in the midst of work to advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain 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 with a single prescription to mitigate the risk of abuse, misuse and diversion.

We remain committed to using our regulatory authority to the fullest extent to address this crisis, including using new authorities granted to the FDA by the 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 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 to help bring this epidemic under control, including ensuring the integrity of their supply chains.

For more information:

Drug Supply Chain Security Act (DSCSA)

FDA Warning Letter: McKesson Corporation Headquarters 2/7/19

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.

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SOURCE U.S. Food and Drug Administration

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