Drug Importation Debate: FDA Opposition and Reform Paths

Introduction: The U.S. Drug Importation Controversy

The debate over loosening regulations on the import of foreign drugs into the United States has proven polarizing among politicians and the public. As drug costs continue to rise, many Americans have expressed shock that the same drugs are often available cheaper overseas.

In a 2003 debate on the topic, Rep. Gil Gutknecht (R-Minn.) pointed out that certain life-saving drugs cost six times more in America than they do in European countries such as Germany, and many Americans have argued that Canadian drugs are also often cheaper (Importing Drugs, 2003). There has been plenty of rhetoric suggesting that greedy pharmaceutical manufacturers — and not market and regulatory forces — are to blame for hiking drug prices and lobbying against the importation of foreign drugs. However, the Food and Drug Administration (FDA), which oversees the approval of pharmaceuticals sold on the American market, is also wary of loosening restrictions. The FDA claims that such a move would open the market to counterfeit drugs and drugs of poor quality.

However, such arguments overlook very real steps that can be taken to make foreign drugs more available in the U.S. market, perhaps bringing down prices for American consumers. By taking cues from health-critical industries that have found ways to regulate product quality, and by taking a tough stance to protect consumers and pharmaceutical manufacturers from counterfeit drugs, the American government can take important steps toward opening the U.S. drug market to more imports.

FDA Opposition: Ineffective and Counterfeit Drugs

Opponents of importing drugs from foreign countries — most notably the FDA — have mainly argued that it would be too difficult to control quality and that there would even be instances of outright counterfeiting. Recent history has shown there is some merit to these claims.

In a statement before the Nevada State Board of Pharmacy, which was debating loosening controls on drug importation, the FDA argued that foreign governments could not be trusted to reliably police the quality of drugs manufactured on their soil (Statement of the U.S., 2006). When Vermont looked to loosen importation controls, the FDA stated that supporting such a move would "be inconsistent with FDA's statutory responsibility to protect the nation's drug supply" (Statements on Vermont's, 2004).

FDA investigations have found evidence of poor-quality drugs being manufactured overseas. In 2004, for example, the FDA was forced to issue a warning when it found that individual Americans were importing from a Mexican supplier versions of the drugs Zocor and carisoprodol that either contained no active ingredient or had substandard potency (FDA Warns Consumers, 2004).

The Canada Problem

One could argue that second- and third-world nations such as Mexico may not be reliable drug suppliers. After all, much of the debate over drug importation has centered on Canada. In 1999, Vermont Congressman Bernie Sanders led a busload of senior citizens into Montreal to purchase cheaper drugs in an act of civil disobedience (Sanders, 2006).

The FDA argues, however, that drugs originating from Canada — or claiming Canada as their country of origin — have also been problematic. In a 2004 investigation, the FDA purchased several common drugs from a website advertising "Canadian generics" and found that many were fake; in fact, one was a controlled substance (FDA Test Results, 2004). Another FDA investigation found that many drugs claiming to originate from Canada are not from Canada at all (FDA Operation, 2005).

Without question, the FDA has demonstrated that dangerous foreign drugs are available for purchase by Americans. The FDA's position that it cannot wholeheartedly endorse looser restrictions on foreign drugs appears reasonable at first glance, given its duty to protect the public health.

Solutions from Other Industries

The notion that quality cannot be controlled when pharmaceuticals are manufactured in foreign countries rings hollow, as other industries responsible for safeguarding public health have successfully overcome the same problem. The water treatment and food processing industries, like many sectors where poor quality could negatively impact public health, have both heavily sourced equipment and materials from Asian countries (Cupp, 2005).

Both the water treatment and food processing markets have created global standards enforced by a variety of certification bodies. Entities such as NSF International (formerly the National Sanitation Foundation) and Underwriters Laboratories have certification programs that manufacturing entities around the world must apply to join. These organizations visit a firm's manufacturing facilities — no matter where they are located — and rigorously inspect the process, testing the firm's products and procedures at regular intervals (About NSF). When the NSF mark appears on commercial, residential, or municipal water filters, or on food processing equipment, consumers can be certain that the parent company has undergone this rigorous certification process.

The market reinforces these standards. No restaurant chain operator would purchase food processing equipment that had not been certified and could contaminate food. The same logic applies to engineers selecting equipment for a municipal water treatment facility serving an entire city.

It is not difficult to extend this logic to the pharmaceuticals industry and require that any drug manufactured overseas be certified by an independent agency. Such certification could add to the price of drugs — the process carries inherent costs — but competition among multiple certification firms could keep those costs in check.

Conclusion

Increasing the importation of foreign drugs is a controversial concept that presents new and difficult challenges to federal and state governments — and to pharmaceutical manufacturers — as they seek to protect the public health. The potential certainly exists for ineffective drugs from disreputable suppliers to find their way into the market, to the public's detriment.

With that said, the challenge is not insurmountable. It is shortsighted to claim that there is no way to police quality at the government level when private industries have already found ways to accomplish the same goal in other health-critical sectors such as water treatment and food processing.

Prescription drug costs are rising and are cost-prohibitive for some Americans. The debate needs to shift from whether the loosening of importation restrictions is possible to how to make it work. The end result will require creativity from a regulatory standpoint — possibly involving private regulatory bodies — and tough action from the U.S. government to protect the public and safeguard the rights of pharmaceutical manufacturers.

Works Cited

About NSF (No Date). Retrieved Sept. 16, 2006 at

Cupp, Tricia (2005). In the Spotlight: Rod Carmer. Retrieved Sept. 15, 2006 at

FDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries (2005). Retrieved Sept. 15, 2006 at

FDA Takes Action Against Company for Illegal Importation of Unapproved, Potentially Unsafe Drugs (2004). Retrieved Sept. 16, 2006 at

FDA Test Results of Prescription Drugs from Bogus Canadian Website Show All Products Are Fake and Substandard (2004). Retrieved Sept. 15, 2006 at

FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico (2004). Retrieved Sept. 17, 2006 at

Importing Drugs (2003). Online Newshour, July 25, 2003. Retrieved Sept. 18, 2006 at http://www.pbs.org/newshour/bb/congress/july-dec03/drugs_07-25.html.

Sanders, Bernie (2006). Prescription Drugs. Retrieved Sept. 15, 2006 at

Statement of the U.S. Food and Drug Administration Before the Nevada State Board of Pharmacy (2006). Retrieved Sept. 16, 2006 at

Statement on Vermont's Lawsuit on Importing Prescription Drugs from Canada (2004). Retrieved Sept. 16, 2006 at