The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA.
On the illicit drugs front, 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.
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.
Today, as part of 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.
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.
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.
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.
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.
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.
