Somewhere Beyond the Sea: The Drug Importation Conundrum

Pharmaceutical Executive

Christopher R. Smith, Senior Counsel in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the firm’s Washington, DC, office, authored an article titled “Somewhere Beyond the Sea: The Drug Importation Conundrum.”

Following is an excerpt:

In the last two years, three states have enacted drug importation legislation, at least 16 states have considered such legislation, and Senator Bernie Sanders of Vermont and Senator Chuck Grassley of Iowa each have pending importation bills at the federal level. With the recent flurry of legislation and pending legislation, Bobby Darin fans may be singing “somewhere beyond the sea, a cheaper prescription drug is waiting for me.” However, before Americans begin singing songs of hope, there are difficult questions that must be answered with regard to drug importation’s coexistence with the Drug Supply Chain Security Act (DSCSA), whether importation generates cost savings, the safety of drug importation, and the impact of importation on consumer behavior and how patients receive care.

The existing state laws and pending federal bills on drug importation vary in scope and detail.  For example, in Florida, the importation law creates a wholesaler importation program for certain drugs from Canadian suppliers which are likely to generate cost savings to Florida Medicaid. The statute also allows for Florida wholesalers, pharmacies, and pharmacists to import drugs from foreign nations, which the U.S. recognizes as adhering to good manufacturing practices. By comparison, Vermont’s law creates a program for wholesale importation of otherwise high-cost drugs from Canada, which would be sold to Vermont residents through local pharmacies.