By: Matthew Rubin, Faegre Drinker Consulting
Food and Drug Administration (FDA) has announced the successful execution of a collaborative enforcement effort with the government of India, the first bilateral operation between the two countries. Between January 28-30, 2020, enforcement officials identified significant threats to United States patients with the arrival of potentially counterfeit, substandard, or otherwise dangerous prescription drugs and medical devices at ports of entry.
Ongoing dialogue on this topic between the US and India first began in September 2019 with a US delegation trip to New Delhi and in close concert with FDA’s India Office of Global Policy and Strategy. Given the millions of packages entering the nine US international mail facilities throughout the country, bilateral enforcement operations remain a critical tool for combating the threat of illegal online drug sellers that place profits ahead of public health and safety.
The results of the joint action, Operation Broadsword, further demonstrate the potential harms associated with illegal online drug sellers and the pervasive threat of sourcing foreign drugs from unsubstantiated retailers. On February 18, 2020, FDA announced the results of a joint campaign with the government of India that identified 500 potentially dangerous or unapproved prescription drugs covering more than 50 FDA-regulated products.
US and Indian enforcement authorities targeted more than 800 shipments of suspected illicit medical products, including controlled substances such as opioids as well as those with indications for cancer or HIV. It was clear that efforts were taken to intentionally mask the point of origin for these products to deliberately evade further scrutiny.
As part of the announcement, FDA Commissioner Stephen Hahn, MD, acknowledged the importance of collaboration in combating public health and patient safety threats due to the influx of illicit products into the country. An FDA press release goes on to note that, “Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe.”
Amid the plethora of proposals and conjectures around the role of online pharmacies and the future of prescription drug importation, these efforts further underscore the need for trustworthy sources of sensitive and heavily relied-upon information, such as that related to the practice of pharmacy and delivery of health care services. Resources like www.safe.pharmacy ensure that consumers have access to legitimate, reputable, and authentic content that is unparalleled in other areas of the internet.