The US Food and Drug Administration (FDA) is working towards stopping the distribution of illegal opioid drugs. FDA made this announcement on 12 February 2019.
The opioid crisis continues to be a serious cause of concern worldwide. The addiction to opioid drugs which are high dosage of pain relievers is a public health issue. Every year thousands of people die due to overdosage of opioids.
There is an illegal distribution of these drugs which forced the FDA to take serious action against this issue. The impact of opioid drugs is huge. FDA is all set to secure the supply chain for authentic and real medications including those of opioids along with stopping the spread of illegal opioids.
FDA is increasing authority, force and prohibiting unapproved products which are being shipped illegally through International Mail Facilities (IMFs). In recent years 86% of the FDA regulated packages entering the US through IMFs contained illegal, counterfeit and strongly dangerous products.
FDA has appointed special agents to the IMFs to work closely with US Customs and Border Protection and FDA regulatory staff. They identify and refer suspicious shipments and bring forward criminal cases for prosecution.
Under the Drug Supply Chain Security Act (DSCSA) FDA on 7 February 2019 issued a warning letter to McKesson Corporation for breaking the law and tampering opioid medicines along with medications for seizures, bipolar disorder, blood pressure, and HIV.
Scott Gottlieb, M.D and FDA Commissioner said, “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.”
Gottlieb also said that “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.”
Gottlieb further adds that “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.”
FDA has also been working to fight against online illegal sale of opioid drugs. Last year in 2018 FDA issued a series of warning letters against 21 websites for marketing and selling unapproved opioid drugs.
In 2018, FDA had also conducted an Online Opioid Summit to discuss the increasing rates of opioid addiction among people and track down illegal online pharmacies and drug dealers.
The FDA is working on new guidelines of the risk and benefits of taking opioid painkillers. FDA is also working on evidence-based guidelines for prescribing opioid drugs to people and to also limit the number of pills a patient receives for a single prescription.