Written by: Matthew Rubin and Libby Baney, Faegre Drinker Consulting
The Trump Administration reignited its focus on prescription drug affordability and access last month through a series of executive orders targeting several longstanding priorities intended to drive costs down. On July 24, 2020, President Donald J. Trump signed four executive orders focused on cost, and an additional fifth executive order less than two weeks later on domestic production of essential medicines and medical supplies.
Aimed at lowering prices and increasing access to prescription drugs for American consumers, the announcement outlined four key priority areas:
- increasing drug importation from foreign countries,
- eliminating kickbacks to pharmacy benefits managers,
- improved access and affordability of insulin and epinephrine, and
- reducing the costs associated with prescription drugs dispensed under the Medicare Part B program.
At this time, the fourth order pertaining to the “most favored nation” clause and benchmarking Medicare Part B prices has not yet been released. Upon the announcement, President Trump indicated that industry had 30 days to come to an agreement before the order would be enacted.
The latter executive order, signed on August 6, is focused on reshoring the medical supply chain for “essential medicines, medical countermeasures, and critical inputs.” Of particular interest to pharmacy stakeholders is the order’s focus on combating the trafficking of counterfeit products via online search and social platforms and third-party sellers. In early August, the United States Department of Justice took down 300 websites as part of a civil complaint alleging illegal conduct by three Vietnamese defendants who were operating hundreds of websites that advertised and offered for sale items such as hand sanitizer and disinfectant wipes.
The July 24 Importation Executive Order outlines three specific actions to be taken by the secretary of the US Department of Health and Human Services to expand access to lower cost prescription drugs:
- Facilitation of individual waivers for the importation of prescription drugs given no public safety risks and demonstrated cost savings under Section 804(j)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act);
- Allow for the reimportation of insulin products for the purposes of medical care under Section 801(d) of the FD&C Act; and
- Complete Food and Drug Administration’s rulemaking process outlined in the July 2019 Safe Importation Action Plan under Section 804(b-h) of the FD&C Act.
Recognizing the scope of this executive order, we encourage regulators, patients, and industry to be extra vigilant against the risks of substandard, falsified, counterfeit and diverted medicines and devices, and other products entering the US drug supply. Stakeholders, including Canadians, continue to express their opposition to importation proposals due to supply and safety concerns.
As has been chronicled in previous articles, there are clear and demonstrated patient health and safety threats posed by illegal online drug sellers. Resources such as NABP’s .Pharmacy Verified Websites Program serve as beacons of legitimate health care information during a time when misinformation online has become increasingly prevalent. From lifestyle medications and antibiotics through COVID-19 personal protective equipment, treatments, and cures, criminals consistently place profits ahead of public health and safety.