States Forge Ahead on Drug Importation Legislation Amid Continued Proliferation of Illegal Online Activity and Harm
June 21, 2019
By: Libby Baney, Jeffrey Ekoma, and Matthew Rubin, Faegre Baker Daniels
As several state legislatures have or are set to adjourn this month, drug importation remains atop many priority lists. To date, Vermont, Florida, and Colorado have passed bills that would permit the wholesale importation of prescription drugs from foreign countries. Seventeen states in total have introduced legislation in 2019 alone, according to the National Academy for State Health Policy (NASHP), totaling approximately 30 individual bills.
In early June 2019, it was also reported that Vermont has extended its timeline for submission of a wholesale importation drug scheme to the Department of Health and Human Services (HHS) until July 2020 to collaborate with other states on policy development. POLITICO’s reporting on Vermont’s importation brought forth an internal state document highlighting 17 high-cost drugs that the state may seek to import. Conditions and therapeutic indications of the potential imported products varied, including birth control, antivirals, pre-exposure prophylaxis, insulins, chemotherapy, and anticoagulants. In partnership with NASHP, regulators from both Vermont and Florida will now work together to develop an appropriate scheme for state-based wholesale drug importation.
HHS Secretary Alex M. Azar has expressed doubt about the safety surrounding importation, and his sentiments are shared by former Food and Drug Administration Commissioner Scott Gottlieb, MD. Both have discussed concerns regarding the complexity and resources needed to scale such a system across the country. Despite this concern, importation efforts in Florida and Colorado have received support from United States President Donald J. Trump, who has directed Secretary Azar to work with states as they develop importation plans.
As the likelihood of state-based wholesale drug importation increases, so have indictments and settlements related to the illegal distribution of opioids, controlled substances (CS), and various other misbranded, substandard, or falsified drugs. In May 2019, the US Treasury Department placed sanctions on Goldpharma, an Argentina-based network of online pharmacies, which sold both legitimate and counterfeit CS via the internet. In a separate case, a Philadelphia man was convicted of selling steroids and other misbranded drugs, such as Viagra®, Cialis®, and trestolone, through bodybuilding websites and other online forums.
Additionally, the Department of Justice took action against the operators of DeepDotWeb in May 2019 for the sale of CS and illicit narcotics through a maze of intricate marketing schemes and website redirects on both the open and dark webs totaling more than $15 million in profit. This multinational takedown called for collaboration between Europol, the Federal Bureau of Investigation, and other international law enforcement agencies to identify and stop these efforts tied to money laundering, kickbacks, and illicit drug manufacture and distribution.
The continued spread and identification of illegal online pharmacies further emphasizes the importance for consumers to be assured that their medicines are safe when purchased in any capacity. With nearly 95% of active online pharmacy websites operating out of compliance with state and federal law and relevant pharmacy practice standards, the .Pharmacy Verified Websites Program remains a critical tool to help patients find safe online sources of medicine.