U.S. Law Against Drug Reimportation: Originally, it Was a Good Idea, But Has Outlived its Purpose

One thing has become abundantly clear over the past several years: federal laws prohibiting Americans from importing cheaper prescription drugs from other countries exist primarily for one reason. That reason is to protect Big Pharma’s exorbitant profits and allow them to continue their merciless price gouging as they bankrupt patients in the U.S. who depend on these medicines. Oddly enough, laws prohibiting drug importation go back 170 years – and back then, there were good reasons for them.

The year was 1848. The conflict that history remembers as the Mexican-American War had ended in February of that year with the signing of the Treaty of Guadalupe-Hildago. Although the U.S. prevailed, there was a number of casualties caused not by combat-related injuries, but due to weak and adulterated medications. In fact, almost since the founding of the nation a little over seven decades, European drug makers had been dumping products of questionable, and even useless efficacy that were unsaleable in their own countries. The issue was not documented until 1846, however, when author Lewis Caleb Beck published Adulteration of Various Substances Used in Medicine and the Arts.

These two related issues finally brought the scope of the problem to public attention. In also led Congress to pass the Drug Importation Act, which was signed into law by President James K. Polk in July of 1848. This law mandated that all medications imported into the U.S. meet standards for strength and purity as established by the United States Pharmacopeia (USP), an early non-profit “watchdog” organization founded in 1820. This early attempt at legislation was not especially effective due to poor enforcement, but it laid the groundwork for later intervention by the federal government.

Although several steps were taken over the next fifty years, the next significant milestone did not arrive until 1906, with the passage of the Food and Drugs Act under the Theodore Roosevelt Administration. While initially motivated by revelations of appallingly unsanitary conditions in meat packing plants – described in the novel The Jungle by Upton Sinclair, published that same year – it also addressed the problem of useless and event deadly “patent medicines” that were widely marketed and sold without any legal oversight. While this law did not prohibit a drug manufacturer from making outrageous and false “cure-all” claims about their products, it made false and misleading statements about a drug’s ingredients and identity illegal. It also prohibited the transport and sale of misbranded and adulterated medications across state lines.

By 1933, it was apparent that the 1906 law was in need of revision. A new bill was introduced that year but ran into stiff opposition from Congressional Republicans, resulting in a legislative battle that lasted for five years. Finally, Congress passed the Food Drug and Cosmetic Act of 1938, which was signed into law by President Franklin Roosevelt.

Since that time, numerous regulations have been passed in order to protect medical consumers, giving government increasing power over the manufacture and sale of prescription and over-the-counter drugs. Although the FDA had been issuing bans on certain medications since the late 1960s in the wake of the thalidomide tragedy, the current wholesale ban on reimportation of prescription drugs began with an incident that took place in California in 1999. An 18-month-old girl died from injections of an analgesic and fever medication called dipyrone, which had been illegally smuggled into the U.S. from Mexico. This resulted in a crackdown the following year and the formation of an FDA special task force known as the Health Authority Law Enforcement Task Force (HALT). Initially, the purpose of HALT was to stop the sale of drugs that are prescription in the U.S. smuggled in from Mexico, where many of the same drugs are available over the counter as well as other controlled substances.

Since then, however, the law has expanded to include any and all prescription drugs from outside the U.S. Oddly, the FDA website says the reason is “because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States,” even though in the vast majority of cases, those drugs are the same. There are a few exceptions to the FDA regulation; drugs that are used for serious conditions for which there are no treatments in the U.S. and are “not considered to represent an unreasonable risk” are permitted, providing that the patient certifies in writing that it is for his or her own personal use or is for the continuation of a treatment started overseas. Patients must also provide the name of their physicians and are limited to purchasing a three month supply.

That does not explain why it is illegal to purchase a medication from Canada that is identical to one that has FDA approval in the U.S. The excuse, according to the FDA, is that “Counterfeit drugs – phony replicas of pharmaceuticals – can surface anywhere,” adding, “historically, they have been more common in foreign countries than in the United States.” While there is some truth to that – there have been numerous documented cases of adulterated and counterfeit prescription drugs entering the U.S. from China and India – the FDA is painting the situation with a broad brush. The fact is that Health Canada (that country’s counterpart of the FDA) has been doing a fine job of ensuring its medications are safe.

Nonetheless, many pundits and organizations are sounding the alarms – among them, the Partnership for Safe Medicines. While this non-profit appears to be the watchdog organization it claims to be, the fact is that it has significant ties to the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s largest and most powerful lobbying group. Not surprisingly, the Partnership has been leading the charge against legislation that would legalize drug reimportation, thus making those medications more affordable for Americans who are burdened with the highest drug prices in the world.

In the meantime, while Congress sits on its hands and does the bidding of Big Pharma while ignoring the needs of its constituents, a number of states, city governments, private employers, and individuals are defying federal law as they obtain their prescriptions from north of the border. This makes the law difficult to enforce – and thus far, nobody has actually been arrested or sentenced for buying Canadian drugs.

Nonetheless, because Congress continues to listen to the industry and has turned its collective backs on the citizens it claims to represent, those who cannot afford to travel or are unable to access Canadian pharmacies will continue to be the victims of Big Pharma’s insatiable and predatory greed. Regulations against drug importation served a valid purpose at one time – but times have changed.

Unfortunately, unless the profit motive is removed from the equation, the law will not.