Wednesday, March 22, 2023
Enough Excuses on Drug Importation a New Transnational Paradigm for FDA Regulation and Lower U.S Drug Prices
Gabriel Levitt (Brooklyn Law School), Enough Excuses on Drug Importation a New Transnational Paradigm for FDA Regulation and Lower U.S Drug Prices, 49 Brooklyn J. Int’l L. 1 (2023):
The U.S. Food and Drug Administration (“FDA”), which enforces drug safety laws, asserts that under most circumstances the importation of prescription drugs is illegal. Yet because of high drug prices in the United States, over the past couple of decades, tens of millions of Americans have imported prescription drugs for personal use. For many, this was their only way to afford them. A unique array of federal laws, regulations, and policies, including the de facto decriminalization of the practice of personal drug importation, have in effect permitted personal drug importation. The same exceptions, however, are not available for commercial drug importation, also called wholesale or parallel importation. While personal drug importation has helped many people afford prescription drugs and could help even more with the correct use of executive authorities and public support, a longer-term solution to high drug prices in the U.S. may require larger, commercial-scale drug importation.
Specifically, legislative reforms to allow for the importation of prescription drugs for commercial use from the European Union (“EU”) would lead to much lower prices on patented, brand-name drugs with no additional risk to public health. That is because drug prices are far lower in Europe than in the United States and the EU’s drug supply is safer. The FDA and the pharmaceutical industry are vehemently opposed to such a policy. They wrongly conflate the importation of lower-cost drugs with counterfeit drugs and rogue online pharmacies and perpetuate the notion that the FDA remains the world’s regulatory “gold standard” in drug safety and that any drug without FDA approval or outside the U.S. drug supply chain is unsafe. These are the primary excuses used to stop drug importation.
The focus today among importation proponents is on state-based Canadian wholesale drug importation programs, which are permissible under current law, but the FDA has yet to approve them. They could help, but Canada is too small for large-scale drug importation. Drug regulatory scholars Thomas J. Bollyky and Aaron S. Kesselheim propose using importation to alleviate generic drug shortages, which can also help prevent generic price spikes, but they do not address the biggest problem: high patented drug prices. Such proposals are captive to the prevailing regulatory paradigm of drug safety that the FDA’s traditional role must be maintained to ensure the safety of the U.S. drug supply. The novelty of this Note rests in its demonstration that the FDA’s mission is better served by a new regulatory paradigm that relies on the international harmonization of drug standards, and recognition that the EU and European Medicines Agency may have eclipsed the FDA’s “gold standard” as a new “platinum standard” for drug safety. It recommends ending the pharmaceutical industry’s distribution monopoly that causes a captive marketplace that keeps domestic drug prices high.