Academic journal article
By Kleiman, Mary Ellen Fleck
American Journal of Law & Medicine , Vol. 32, No. 2/3
"This Constitution, and the Laws of the United States . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding."1
Under the Supremacy Clause of the United States Constitution, federal law, such as the Federal Food Drug and Cosmetic Act ("FDCA")2, is supposed to be the "supreme Law of the Land." The FDCA establishes a national closed domestic distribution system for approved prescription drugs in an effort to ensure drug integrity and safety.3 In doing so, it purportedly sets the "gold standard" for prescription drugs regulation around the world.4 Lately, though, this "gold standard" has been tarnished by personal importation, the practice of buying prescription drugs directly from foreign pharmacies-primarily Canadian-in conflict with the FDCA's restrictions on unapproved drugs and importation.5
States are pursuing programs and passing laws which are only exacerbating the problem.6 Critically, the responsibility for our "gold standard" system is not solely that of the federal government - states are responsible for regulating and ensuring the integrity of the practice of pharmacy in their respective jurisdictions through their state boards of pharmacy (BOPs).7 But some states are implementing initiatives, passing laws, and enacting regulations aimed at allowing foreign pharmacies to import prescription drugs into the United States in an effort to aid their citizens in obtaining less expensive prescription drugs.8 Yet these activities come into direct conflict with the express terms and purposes of the FDCA. As a result, the FDCA these days seems to be followed by an asterisk which qualifies its supremacy as federal law. This qualification seems to be that the FDCA is supreme "unless Americans want to obtain cheaper prescription drugs from foreign pharmacies."
This article will summarize and explore the FDCA provisions most relevant to the prohibitions on the importation of prescription drugs and their underlying purposes. It will then turn to the states, starting with how states have traditionally regulated non-resident pharmacies. Then, it will move on to what the states are now doing at the legislative, regulatory, and executive levels to facilitate importation from foreign pharmacies, regardless of the restrictions contained in the FDCA. From there, this article will examine whether the states are violating the Supremacy Clause of the United States Constitution in pursuing initiatives to import drugs from Canada and elsewhere. Finally, the article will conclude with a discussion about how the states' promotion of foreign pharmacies may impact the practice of pharmacy and safety of patients if left unchecked.
II. FDCA CREATES THE "GOLD STANDARD" OF PRESCRIPTION DRUG REGULATION
A. FDCA PLACES STATUTORY RESTRICTIONS ON IMPORTATION OF PRESCRIPTION DRUGS
Under the FDCA, re-importation and importation (referred to jointly as "importation") of prescription drugs for a consumer's personal use is illegal. A prescription drug that is manufactured in the United States and then exported may not be reimported back into the U.S. by anyone other than the manufacturer of the drug.9 In addition, prescription drugs made elsewhere for non-U.S. markets are not approved by the FDA,10 properly labeled,11 or dispensed with a valid prescription and, therefore, cannot be introduced into interstate commerce.12 According to the FDA, "[i]n general, all drugs imported by individuals fall into one of these prohibited categories."13
The reason is that all prescription drugs are not created equal.14 FDA drug approvals are specific in terms of several factors.15 "Generally, drugs sold outside of the United States are not manufactured by a firm that has FDA approval for that drug. Moreover, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all the requirements of the United States approval, and thus is considered unapproved. …