FDA recently stopped importation and sent warning letters to numerous online sellers of illegal opioids, oncology drugs and other medicines.
FDA recently stopped importation and sent warning letters to numerous online sellers of illegal opioids, oncology drugs and other medicines.
During Operation Pangea XI, FDA sent warning letters to 7 different networks operating 465 websites selling misbranded and unapproved drugs to US consumers. The sites sell “potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs,” FDA said in a statement.
Related: New naloxone provides more opioid overdose options
FDA also refused entry into the United States of 794 illegal drugs from web sites in the United Kingdom, India, and Canada. Plus, the agency brought 450 domain names, such as www.nextdaypills.com, to the attention of search engines and the appropriate domain name registries and registrars.
“The sale of potentially dangerous and counterfeit drugs by criminal networks on the internet is a large and growing threat to the public health,” said FDA Commissioner Scott Gottlieb, MD, in the statement from FDA.
Related: FDA warns CBD supplement maker
The illegal online pharmacies are often run by sophisticated criminal networks that “knowingly and unlawfully distribute illicit drugs, including potentially counterfeit medicines and controlled substances both on the surface and dark web,” Gottlieb added. “Consumers go to these websites believing that they’re buying safe and effective medications. But consumers are being put at risk by individuals who put financial gains above patient safety.”
Gottlieb said he is particularly concerned about the ease with which consumers can gain access to controlled substances and prescription opioids online. “This is one reason why we’ve stepped up our efforts, both from a policy and enforcement standpoint, to take these bad actors down.”
FDA provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.
Read more: FDA warns about fraudulent flu products
Trelegy and Breo Offer Incremental Improvement Over Generics
March 3rd 2025The Institute for Clinical and Economic Review has prepared a special report on Trelegy and Breo, two therapies that treat patients with chronic obstructive pulmonary disease that are part of CMS's drug price negotiation program.
Read More
FDA Accepts sNDA for Zoryve Cream for Atopic Dermatitis Treatment in Young Children
February 26th 2025This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The PDUFA target action date of October 13, 2025, is set for its decision on the application.
Read More
FDA Accepts BLA Resubmission for Follicular Lymphoma Drug, Odronextamab
February 26th 2025The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
Read More